It seems we stirred the hornet’s nest when we posted that Indian drug manufactures are not as bad in GMP compliance as the prevailing perceptions the media would have us believe. A review of the FDA’s Inspections database indicates that auditors find similar numbers of major and minor findings in India as at sites located in other … Read more
Since the passing of Tobacco Control Act in 2009, FDA has been actively and aggressively going after all tobacco products. Last week we discussed in details the actions FDA has taken to strictly regulate sale of tobacco products, primarily cigarettes. One thorn on FDA’s side has been e-cigarettes which currently FDA cannot regulate. In the 2009, FDA … Read more
Two weeks ago, I wondered if Indian GMP manufacturers are indeed as bad as one would be led to believe based on the constant headline news of FDA’s audit notices to manufacturing sites in India. A review of FDA’s inspections database shows that the truth may be somewhere in the middle. Indian GMP sites are found to have issues … Read more
New drug approval by FDA is based on multiple clinical trials. It has always been hard for consumers to get a summary of all clinical trials conducted in support of a given drug. FDA recently created a tool to summarize the main clinical trials done to seek FDA approval. FDA recently released a web-page called Drug … Read more
Since the passage of the Tobacco Control Act in 2009, FDA’s Office of Tobacco Products (OTP) has been aggressively asserting its authority over all kinds of tobacco products. In its short 5 year life, the OTP has issued more Warning Letters than both CDER and CBER combined. OTP issued 331 Warning Letters to 273 by CDER and a measly 26 by … Read more
If your prescription drug is too expensive, can you simply buy a compounded drug to get a cheaper version? And if this goes forward, does it not create a challenge for all developers of 505(b)(2) or even generic drugs? What about expanding this logic to the very expensive biological drugs? Would FDA allow that? The … Read more
In recent years, any event of an FDA Warning Letter or other actions towards drug manufacturers located in India is headline news for most media sources. Warning Letters to Indian manufacturers are projected as evidence of an industry wide culture of non-compliance and there seems to be a strong perception that Indian drug manufacturer may be the worst GMP offenders in the entire industry. … Read more
In the last 4 weeks, two things happened in the genetic diagnostic kits. The genetic diagnostic kit developed by 23 and Me got approval from FDA, albeit for a much more specific area than the company wanted. And Pathway Genomics got a letter from FDA asking to stop selling its cancer genetic diagnostic kit. This story is an … Read more
Each year the medical device reviewers release the top 10 areas of priority for the coming year. For the coming year, CDRH’s list of top priorities includes increased emphasis on human factors in regulatory decisions. Of the 10 areas of priority, about 5 discuss review and evaluation of human factors in medical device design, approval and post-market … Read more
Recently several reports have raised the question of authenticity of the cell lines used in research and development activities. Most testing labs and academic centers do not validate cell lines before use. Rather it follows the honor code of trusting the label given by the provider. But cell-line misidentification has been a major concern for a few … Read more
