Regulatory Affairs Update; FDA 483 and Warning Letters Trends for 2012
Those of you who manufacture products approved by the US Food and Drug Administration (FDA) are well aware of the importance of complying with Current Good Manufacturing Practices (cGMP) during FDA mandated inspections of your manufacturing facilities. Failure to comply with cGMP requirements during an inspections results in the issuance of 483s. And if you fail to adequately address the concerns of the agency outlined in 483s, it may ultimately result in issuance of warning letter to your company.
FDA is more vigilant and aggressive than ever before with its 483 and warning letter enforcement procedures. In the words of Commissioner Margaret Hamburg, FDA is quick, visible and vigilant. With this in mind, it may be worthwhile to participate in a webinar offered by Expert Briefings.com entitled “Top Compliance Trends for 483 and Warning Letters for 2012—Based on Rare FDA Data.”
The webinar will be held on March 8, 2012 from 2:00-3:30 PM EST and Dennis Moore, Managing Partner, AUK Technical Services and a 28 year veteran FDA investigator will lead it.
Topics to be covered include:
- Top warning letter trends for 2012, such as more 806 enforcement
- The Top 10 QS 483 Observations for 2010 and 2011
- Most common quality system failures for drugs for 2010
- Top drug and device citations in 483s for 2010
- Top drug and device warning letter citations for 2010
- Total 2010 BIMO inspections for CDER, CBER, CDRH, and CVM
- Details on clinical investigator, sponsor/monitor and IRB audits for 2010
- Most common sponsor deficiencies for 2010
- The rising trend of ‘cease to market’ letters, one of which hit a NY pharma company in 2011
- The total number of 483s issued in 2010 and 2011 – an all time high
- Total CAPA 483 observations in 2010
- How long to receive a warning letter, based upon which offices issues it
- 483 inspection targets for drugs and devices for 2010, 2011, and 2012
- Total warning letters issued by drug and device category in 2010
- Which district offices write the most warning letters
- How long to receive a warning letter, based upon issuing office
- Warning letters issued by QS system for 2010
- 483s broken down by QS subsystem for 2010
- Warning letters by CFR section
- Top device 483 observations for 2010
- Details on process validation observations for 2010
- Design control 483 observations by category for 2010
- Click here to visit Expertbriefings.com.
Click here to visit Expertbriefings.com.
I hope to see (hear ?) you at the webinar!
Let’s start with the good news first. A 
Sandoz, the generics division of Novartis, is currently the world leader in the biosimilar market. In fact, if it was not for Sandoz, the biosimilar industry may never have gotten started in the first place! As some of you may know, Sandoz sued FDA (and won) to gain approval of its biosimilar human growth hormone. While FDA contends that Omnitrope is not really a biosimilar (it was approved as a “drug” rather than a biologic) most analysts agree that it was the first biosimilar product ever approved and sold in the US. 
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Mark Senak, author of the (1).jpg)
About two years, I posted an 
Last week, I reported in a 
Last week, the US Food and Drug Administration issued a .jpg)
Last week, US Food and Drug Administration (FDA) Commissioner 
Late last week, Janet Woodcock, head of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation (CDER) made 
Over two years ago at the beginning of the social media/pharma debate, I 
While there is enormous unmet medical need out there, I never knew that the morbidity and mortality resulting from scorpion stings was so great. But, as the old adage goes; you learn something new everyday. To wit, the US Food and Drug administration earlier this week approved the first-ever treatment for scorpion stings..jpg)
The recent E. coli 0104:H4 outbreak of gastroenteritis in Europe that sickened thousands and killed over 20 people was one of the largest foodborne disease outbreaks in the world (for the latest updates check out this
For the past few years, I along with many others have advocated the use of social media platforms (mainly Facebook, Twitter and YouTube) by life sciences companies. Despite a very positive beginning by companies like Novo Nordisk, Johnson and Johnson and others, the implementation of social media in the life sciences industry has been stymied by a lack of regulatory guidance by the US Food and Drug Administration (FDA) and legal and commercialization concerns. While many believe that FDA guidance on the topic will be the panacea that they were waiting for, I personally don’t believe that it will make one bit of difference. That said, 
About a year ago, I suggested that real time
During the Bush Administration I, along with many others, was a harsh critic of the US Food and Drug Administration (FDA). The criticisms that I levied against the agency were mainly based on its inability to adequately maintain the safety of the American drug and food supply and Bush’s repeated attempts to politicize the organization and render it useless. That said, it is amazing how much has and will change at the agency during the Obama Administration. To wit, Margaret Hamburg, the current FDA Commissioner yesterday
Mark Senak, author of the highly informative and well written Eye on FDA blog, 
Big pharma continues to lament the increased scrutiny being imposed on it by the US Food and Drug Administration (FDA). Like it or not, the agency’s directive is to insure that the drugs that it approves are safe and effective for the American public. And, for the most part, the agency does its job and frequently catches companies that attempt to break the rules..jpg)
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As many BioJobBlogger readers know, the life sciences industry is highly regulated. And, companies that market and sell drugs must be compliant with the Current Good Manufacturing Practices (CGMPs) mandated by the US Food and Drug Administration (FDA) and other regulatory agencies.
The Pharmalot Blog 
The NY Times
US Food and Drug Administration (FDA) inspections of drug and devices manufacturing facilities are typically anxiety ridden exercises that can strike fear into even the most seasoned quality and regulatory affairs professionals. And, most manufacturing facilities do not escape these inspections unscathed and are routinely cited, in many cases, for minor infractions.
The US Food and Drug Administration 
Like it or not, the possibility of money and profit drives science just like it does any other field. Therefore, it should come as no surprise that a few genetic testing companies .jpg)
BioJobBlog readers who understand .gif)
Last week, the US House of Representatives voted to cut FDA funding by $220 million. The House vote was not surprising given the prevailing attitude among many pharmaceutical and biotechnology company executives that FDA approval of new drugs and devices has become increasingly difficult. While there is no question that the current approval process for new drugs and devices has become more rigorous as compared with the incredibly lax process (and in some cases, the almost non-existent process) used during the Bush Administration, the FDA is simply fulfilling the mandate for the agency when it was created in 1938. That is: to provide the American public with SAFE and efficacious drugs to treat unmet medical need. 
Many life sciences company executives will tell you that getting US Food and Drug Administration (FDA) approval for their products has gotten tougher than it has been in the past 10 years or so. This shouldn’t come as a surprise to most BioJobBlog readers because there was almost know regulation of pharmaceutical, biotechnology and medical devices products during the eight years that Bush was in power. Seemingly, many life sciences companies have forgotten that FDA’s mission is to provide the American public with SAFE and efficacious drugs and devices; not to quickly approve products to bolster a company’s stock share price. That said, some medical devices companies, like their pharmaceutical and biotechnology cousins, have begun to complain about the FDA regulatory process for medical devices..jpg)
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Two years ago Merck .jpg)
The US Food and Drug Administration (FDA) is one of those federal agencies that everyone loves to hate. Sometimes I think the FDA is more vilified than the Internal Revenue Service! Nevertheless, FDA’s mission is to provide the American public with safe and efficacious foods, medicines and cosmetics. And, despite some highly publicized missteps like Vioxx and Avandia in recent years, the agency has done a great job since it was created in 1930.
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A new 
Biocon, one of India’s leading biopharmaceutical companies today
Late last week the US Food and Drug Administration (FDA) .jpg)
Whether you like President Obama or not, the changes he made in the leadership at the US Food and Drug Administration (FDA) is beginning to yield results. After just two years, the agency is well on its way to modernization and overcoming its descent into the dark ages during the failed Bush Administration.
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The pharmaceutical industry, not unlike all big business during the disastrous Bush Administration, was virtually unregulated. Bush and his cronies managed to accomplish this feat by destabilizing the US Food and Drug Administration (FDA) and essentially hamstringing any regulatory authority that it had. Not surprisingly, many pharmaceutical companies saw an opportunity to increase their bottom lines by engaging in off label marketing of many of their approved drugs—a practice clearly forbidden by the agency. 
Mark Senak, author of the EyeonFDA blog and a feisty social media advocate and enthusiast today 
When I saw one of today’s 
Regulatory affairs professionals (RAP) are by far some of the most important employees at pharmaceutical, biotechnology and medical devices companies. Without RAPs, the requisite regulatory documents would not be filed and new drugs and devices would not be approved for marketing and sale.
Mark Senak, a pharmaceutical social media advocate and the author of the 
Can things get any worse at Genzyme? First there were the 
The New York Times 
The .jpg)
Earlier this month, Merck BioVentures, the company’s new division focused on developing follow-on biologics aka biosimilars announced that it was 
Pfizer today 
Johnson & Johnson’s McNeil Consumer Healthcare, already under Congressional investigation for selling allegedly tainted Tylenol, announced late Tuesday that it was recalling other products made in the Puerto Rico manufacturing facility in question..jpg)
After weeks of bad press regarding
The US Food and Drug Administration (FDA)
Johnson & Johnson is arguably one of the world leaders in bringing social media to the pharmaceutical industry. Marc Monseau and his dedicated team oversee a network of blogs, video channels and Twitter feeds while some of J&J’s brand companies even sponsor patient advocacy communities like ADHD Moms and ADHD Allies. However, the company’s recent handling of manufacturing problems and recall of Tylenol and other pediatric medicines seemingly flies in the face of openness and transparency; two of the underlying tenets and guiding principles of social media.
Genzyme 
About a year ago I posted an .jpg)
The recent .jpg)
Orphan drug manufacturer Genzyme today issued a .jpg)
The US Food and Drug Administration (FDA) has advised GlaxoSmithKline (GSK) to 
Medicis Pharmaceutical, the maker of Dysport a drug approved by the US Food and Drug Administration (FDA) to smooth skin furrows between the eyebrows, recently
Mark Senak, author of the incisive 
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The rising cost of healthcare, increasing drug prices and the restrictive nature of the formularies of many insurers and third party payers is forcing a growing number of Americans to rely almost exclusively on generic prescription drugs. The trouble is that most Americans know very little about generic drugs; mainly because big pharma has done its best to minimize the discussion about generics and continues to portray generic manufacturers as less than reputable purveyors of prescription drugs. Because of this, I think that American ought to begin to understand an industry that increasingly will play a major role in the US healthcare system. So here goes:.jpg)
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A rare or orphan disease is defined in the US as one that affects fewer than 200,000 at any given time. It is estimated that there are 6000 to 8000 rare diseases in the world today. Because the number of patients afflicted with orphan diseases is so small, drug companies have historically been reluctant to invest money to discover and develop new treatments for them. The dearth of treatments for rare diseases induced Congress to pass the.jpg)
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Harrison Ford’s new movie “Extraordinary Measures” (also starring Brendan Fraser) is loosely based on 
As Jonathan Richman, author of the Dose of Digital blog focused on pharmaceutical marketing aptly put it, its time to “stop talking about social media.” “.jpg)
For many years, I taught medical students that the emergence of antibiotic resistant strains of bacteria primarily resulted from the overuse and misuse of antibiotics by physicians. While this seemed to make sense, I started chatting in the late 1990s with .png)
Mark Senak, author of the 
Jonathan Richman, author of the Dose of Digital Blog, got it exactly right in today’s post entitled “(2).jpg)
Earlier this week, Mark Senak who writes the EyeonFDA blog, offered his i
I was chatting with a fellow medical writing colleague the other day and the topic of direct-to-consumer (DTC) advertising came up. I suggested that DTC advertising is largely ineffectual but my colleague suggested otherwise. To prove his point, he sent me a fascinating article entitled “Direct-to-Consumer Advertising: An Attitude Survey of Psychiatric Physicians (.jpg)
Mark Senak who writes the EyeonFDA blog has .jpg)
In a previous 
Mark Senak, social media advocate and author of the EyeonFDA blog, has been spot on with his commentary on the recent public hearings held by FDA to unravel the social media conundrum facing the life sciences industry. Despite its good intentions, the agency is intent on applying an anachronistic method of developing guidance (designed for processes that undergo incremental changes) for a technology that changes rapidly and is ill-defined. In other words, they are trying to force a square peg into a round hole—it simply won't work!
The public hearing held by FDA last week in Washington DC to address social media and promotional advertising in the pharmaceutical seems to have altered the agency’s perspective on all things digital. Today, according to a.jpg)
I suspect that many of you (after reading the title of this post) might be expecting another rant about the need for new antibiotics to treat infections caused by multiple drug resistant strains of bacteria. Sorry to disappoint you because that isn’t what this post is about. After reading and listening to several seemingly disparate radio and newspaper stories this morning, I decided to combine three different stories into a single post that touches on several common themes..jpg)
Unlike many of my social media colleagues, I’m not attending the FDA public hearing taking place in Washington, D.C today (Friday the 13th oh my). I wanted to attend and actually testify but I didn’t understand how the process works and blew my opportunity. However, I will be prepared for rounds 2 and 3 and beyond. I can assure you that this will not be the last public meeting organized by the agency to develop guidance for the use of social media in pharmaceutical marketing and advertising. .jpg)
In today’s edition of the incisive EyeonFDA blog, Mark Senak, provides a (1).png)
e-Patients Connections 2009 
Late last week, the US Food and Drug Administration (FDA) .jpg)
Without fanfare, 
The answer to this question is not yet! However, the 
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The bad news is that the US unemployment rate is close to 10 percent. The good news is that the government is looking for scientists at FDA, NIH, USDA, CDC, EPA and other agencies. For those of you who haven’t applied for a government job, the process can be daunting and overwhelming. To alleviate some of the pain, Cyndi Fischer, MSA at the .jpg)
My son, who is a 9th grader, was recently asked to write an essay for his social studies class about the application of Machiavellian principles to modern day rulers and governments. One of 
sued the US Food and Drug Administration (FDA) in federal court yesterday because it believes that regulations banning off label promotion of prescription drugs violates the company’s right to freedom of speech and impedes its ability to provide physicians with information regarding patient safety.
that W. Scott Harkonen, MD the former chief executive of InterMune, a Brisbane, CA biopharmaceutical company, was convicted yesterday for issuing what federal prosecutors called a misleading press release that contributed to off-label sales of the company’s drug Actimmune.
A spokesperson at the US Food and Drug Administration (FDA) (3).jpg)
Mark Senak at the
Mark Senak who runs the.jpg)
The U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that clinical data support both the efficacy and safety of Cervarix®, GlaxoSmithKline (GSK) cervical cancer vaccine.
in today’s New York Times lamenting the marketing practices utilized by drug companies to inform physicians about their products. While these practices may be troubling to legislators and the American public, everybody who works in the life sciences industry including regulatory agencies like the US Food and Drug Administration (FDA) understands the “rules of the game” and how it is played. However,.jpg)
Pharmaceutical,biotechnology and other companies that sell prescription drugs and devices are deathly afraid of adverse events (AEs) associated with their products. For those of you who may not know, companies with approved prescription drugs and medical devices are required to track and report any adverse events associated with their products to regulatory agencies like the US Food and Drug Administration (FDA). If FDA receives enough AE complaints about a product, the agency will investigate to determine whether or not there may be efficacy, safety or tolerability issues with it. And, if FDA thinks that the AEs are legitimate, it may ask a company to conduct Phase IV clinical trials with the product in question or require that changes be made to the product’s label. Not surprisingly, these outcomes can be time consuming and perhaps more importantly, costly. Label changes—especially for blockbuster products—frequently lead to changes in physician prescribing habits which can translate into a loss of revenue. Despite the fact that ALL drugs exhibit AEs, many companies falsely cling to the hope that there will be few, if any, AEs reported for their products..jpg)
Mark Senak, author of the .jpg)
Until today, direct-to-consumer advertising (DTC) has received very little attention during the recent spate of debates over healthcare reform. The (1).jpg)
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BioJobBlog and 
Mark Senak, who writes the outstanding 
As the (1).jpg)
The debate, if you can call it that, over whether or not interactive social media platforms like .jpg)
Mark Sendak, a social media enthusiast and author of the 
A much-anticipated 
As we all know, the H1NI pandemic has been raging on for close too 10 ten days now. Curiously, “Fear & The Flu: The New Age of Pandemics” is the title this week’s cover story in Newsweek magazine. From an informational standpoint point, “this may be too little, too late”—as the old saying goes. While the Internet has been around for over twenty years now, government agencies, most notably the US Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) continue to rely almost exclusively on old media to communicate with the American public during infectious disease outbreaks. Apparently, the administrators who run these government agencies haven’t been listening closely enough to President Obama’s assertion that “we live in the digital age.”.jpg)
One day after the US Food and Drug Administration (FDA) approved Dysport, a new product that will compete with Botox, the 
Twitter, which is currently de rigueur in social media circles, is emerging as one of the most powerful branding and marketing social media tool that has been developed to date. .jpg)
Earlier this week, the US Food and Drug Administration (FDA) sent .jpg)
Today's New York Times reported that the US Food and Drug Administration (FDA) issued warning letters and ordered 14 pharmaceutical and biotechnology companies to stop running what it calls misleading ads on internet search pages displayed by search engines like Google. The agency faulted the companies for failing to identify product names (brand) and not listing potential side effects (only benefits) for the drugs. In other words, the ads lacked “fair balance” something that FDA stresses and that all drug makers are very familiar with. 
The US economy has lost about 7.1 million jobs since December 2007 and nationwide unemployment is hovering around 8.5 percent. Despite the lost of about 80,000 pharmaceutical jobs over the past three years and unprecedented consolidation taking place in the life sciences sector—Merck-Schering Plough, Pfizer-Wyeth and Roche-Genentech—the job prospects for scientists at biotech companies, medical devices and diagnostics, and government appear to be stronger than anticipated. While drug discovery and sales jobs may be scare, there are rapidly emerging opportunities in the fields of medical communications, regulatory affairs, biomanufacturing, clinical trials management , bioengineering, medical devices/diagnostics and website development and management..jpg)
Tainted pistachio nuts are the culprit for this week’s Salmonella outbreak. Fortunately, Kraft Foods’ quality unit was doing its job and was able to alert consumers about the problem before the outbreak reached epidemic proportions. At present, there are only two suspected cases of Salmonella gastroenteritis that may be linked to tainted pistachios. The contamination has been traced back to a California company which, according to reports, is the second leading producer of pistachios in the US..jpg)
Previously, the US Congress proposed legislation to create a regulatory approval process to allow the Food and Drug Administration (FDA) to approve generic versions of blockbuster biotechnology drugs known as follow-on biologics (FOBs). While a regulatory pathway exists for approval of generic versions of small molecule drugs (as outlined in the .jpg)
I just returned from a weekend of teaching regulatory affairs to biotechnology students at Georgetown University where I tried to convince them that the US Food and Drug Administration (FDA) is fundamentally sound despite its near demise during the Bush administration. Even before the Bush-induced wreckage, the agency was chronically understaffed, under funded and had serious leadership and morale problems. This, coupled with two nationwide Salmonella outbreaks in the past year, several highly publicized drug recalls, and steadily declining drug approval rates has prompted its critics to propose that FDA be split into two separate agencies—one that oversees the drug industry and another that would have responsibility for cosmetic and food safety. For those of you who may not know, FDA became responsible for oversight and regulation of the food and drug industries, in addition to the drugs, after passage of the Food, Drug and Cosmetic Act in 1938.
As many of you know, the life sciences industry, one of the most highly regulated industries of the economy has been hesitant and reluctant to embrace social media to reach out to patients, physicians and the lay public. This is because the US Food and Drug Administration, specifically Division for Drug Marketing, Advertising and Communications (
According to a report on NPR’s All Things Considered program, the Obama Administration has nominated Margaret Hamburg, MD to head the US Food and Drug Administration. Dr. Hamburg is a former health commissioner in New York City who has worked on issues surrounding infectious diseases and bioterrorism. In New York, she instituted a needle-exchange program to help prevent the spread of HIV. She also set up a program, in which health workers went to tuberculosis patients’ homes to help them manage their drug regimens..jpg)
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About a year ago, I was eating lunch and bunch of pharma executives were at the table next to me. I inadvertently overhead bits of their conversation and I heard the words, Facebook, MySpace and YouTube mentioned. This suggested to me that pharma was more aware of social media (and its business implications) than pharma publicly cared to admit. Pharma has been reluctant to embrace social media because of possible legal and regulatory ramifications. Nevertheless, a few companies have decided to boldly go where no pharma company has gone before—to YouTube.
Allergan, the drug maker that brought us Botox is at it again! The company has a new .jpg)
The Bush administration spent the last eight years trying to weaken and dismantle the US Food and Drug Administration (FDA). I thought the carnage at the agency would end in the waning days of one of America’s worst leaders. Sadly, I was mistaken.
Targanta Therapeutics, a Cambridge, MA-based biopharmaceutical company, announced that it 
Sometimes reality is stranger then fiction. The Pharmalot blog reported today that US Senator 
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The 
An article in today’s New York Times
After beating Wall Street expectations and disclosing positive results from an osteoporosis (densomab) clinical trial, .jpg)
A post at the Pharmalot blog.jpg)
In an attempt to assuage the jitters and financial concerns of investors who own stock in pharmaceutical, biotechnology and medical device companies, the US Food and Drug Administration announced yesterday that it will be change the format of the letter received by companies whose products are not ready for approval..jpg)
The old adage “When it rains, it pours” is particular apt for the bad news that has plagued the once venerable Merck & Co for the past five years. First, there was the Vioxx scandal, followed in short order by the Vytorin and Singulair messes and now it appears that the company’s new anti-cervical cancer vaccine, Gardasil, may have —pardon the expression — a few “warts” on it. .jpg)
Somebody once said “Jews know two things—suffering and where to find good Chinese food”. Since I am Jewish, it is not surprising that I have experienced a fair amount of suffering throughout my life and, wherever I go, I seem to know where to find “good” 
The regulatory problems at Wyeth continue. The US Food and Drug Agency .jpg)
The newest culprit in the direct-to-consumer (DTC) television ad cat and mouse game between pharmaceutical manufacturers and US regulators is Cordis, a medical device subsidiary of Johnson & Johnson. The ad in question deals with promotion of the use of a 
In 2004, the European Commission adopted a new directive that paved the way for legal approval of biosimilars in the European Union (EU). To date, five (5) biosimilars have garnered marketing approval in the EU. Of the five, two are generic versions of recombinant growth hormone (rHGH)–Omnitrope (Sandoz) and Valtropin (Biopartners). .jpg)
As I mentioned in previous posts, things are simply not going Merck’s way. Merck has been 
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seems like nothing is going right for Merck these days. 
After weathering the Vioxx storm for the past three years, Merck again finds itself in choppy and unchartered waters. Still reeling from the Vytorin flap that erupted two months ago, there are new allegations that its blockbuster allergy and asthma medicine, Singulair, may be linked to suicide. The US Food and Drug administration (FDA) was quick (this time) to announce that it is launching an investigation into reports that suggest that Singulair may cause patients taking the medication to commit suicide. Merck received approval for Singulair in 1998 and it had sales of $4.3 billion in 2007..jpg)
I spent the entire morning reading various articles, blog posts and comments about what is wrong with the US Food and Drug Administration (FDA). Not surprisingly, phrases like “drug lag”, the large size and costs of clinical trials, political and corporate influence, reduced numbers of NME approvals etc appeared ad nauseum. These are the same old, tired complaints with the agency that have been bandied about for the past 10 years or so. 
Ed Silverman over at Pharmalot reported today that Health Canada, the Canadian equivalent of the FDA has beaten the 
ephalosporin antibiotics.
FDA approvals of biopharmaceutical products have decreased in recent years. This includes recombinant proteins and monoclonal antibodies and cancer therapeutics. In the decade from 1996-2005, an average of 16.6 new drugs were approved each year. In marked contrast, there were only 11 and 12 new medications approved in 2006 and 2007, respectively. 
According to Johnson & Johnson, a panel of advisors for the Food and Drug Administration, in a surprise decision, supported keeping Epogen, Procrit and Aranesp from Amgen and Johnson & Johnson on the market for use in cancer patients who are anemic from chemotherapy..jpg)
According to a 
Erythropoietin (EPO) is a hormone (protein) that regulates red blood cell production in humans. Back in the 1980s, scientists at a fledgling biotechnology company called Amgen determined that recombinant EPO was highly effective for treating anemia. Amgen owned the intellectual property rights to the EPO gene and decided to sell the recombinant protein encoded by EPO (called epoetin) as a treatment for anemia.
After an exhaustive nationwide search, FDA Commissioner Andrew von Eschenbach decided yesterday that Janet Woodcock, a career FDA staffer, was the best choice to lead the agency’s struggling Center for Drug Evaluation (CDER). For Dr. Woodcock who has been the acting head of CDER since September, this will be the second time that she was tapped to lead the center. She was previously appointed to the top CDER job in 1994 by then FDA Commissioner David Kessler (the last time FDA had any real leadership). 
Where have the folks at FDA been hiding for the past decade? I thought that by now everybody had heard about multi-drug resistant bacteria and the need for new antibiotics. Why, I bet that even President Bush knows this –hmmmm– well, okay– but you get my point!
For the past year or more, the US media has been vociferously bashing tainted imported Chinese goods any time it can. The tainted products have ranged from toys to dog food and most recently to .jpg)
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The US Food and Drug Administration said Monday
By law, drug makers are prohibited from marketing or promoting (in any way) their medicines for uses that have not been approved by FDA. But, somewhat paradoxically, physicians who are licensed to practice in the US can prescribe drugs for uses beyond FDA-approved indications, a practice known as off-label use. The agency is no stranger to the issue of off-label drug use and has vigilantly policed the industry over the last decade to prevent the practice. Drug makers including Pfizer, Astra Zeneca, Eli Lilly, Amgen and others have been targeted by federal prosecutors for off-label marketing practices. 
The Bush administration's proposed 2009 fiscal year budget for the FDA
US Food and Drug Administration regulators 
Things are not going well these days for Wyeth or the US Food and Drug Administration. In the latest of a series of complaints over FDA's safety review of drugs and industry influence on the agency, .png)
The US Food and Drug Administration announced late last week.jpg)
Can anything else go wrong at Amgen? 
t to discuss scientific considerations for safety testing for cellular therapy products derived from human embryonic stem cells. , the committee will meet to discuss updates on the following topics: (1) Research management related to the September 29, 2005, review of research programs of the Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research; (2) 's Somatic Cell Therapy Letter; and (3) recently released FDA guidance documents." .jpg)
The FDA 
Genentech announced yesterday
In an attempt to dispel the notion that it is 
Although industry and academia share a common bond (no pun intended), which is obviously science, the lexicons of these two seemingly similar but parallel worlds are markedly different. For example, do you know what the acronyms IND, NDA, cGMP, cGLP, BLA, CTD, PK or PD stand for? If you cannot decipher any of them, you ought to forget about getting a job in industry and stay in academia. If you know what 95 % or less of them mean, I highly recommend that you get some additional training before applying for your first industrial position. If you are one of the lucky few who recognized and correctly interpreted 100% of the acronyms, you are either working in industry or recently completed some postgraduate training in drug development and regulatory affairs. The point that I am trying to make is that you cannot possibly expect to get a job in industry if can’t speak the language that you need to know in order to succeed! As the old saying goes “You need to learn how to walk before you can run”. 
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The New York Times reported today
Can anything else go wrong at Pfizer? Unfortunately for Pfizer employees, the answer is yes. 