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
I have always wondered why my daughter and son have different preferences even though we have consciously tried to keep our home gender neutral. Both share similar toys, wear similar clothes, eat similar food and are provided similar nurture. Still my girl prefers pink clothes and stuffed animals while my son loves blue and cars. … Read more
One more survey makes bold claims regarding the risks of dietary supplements, particularly those of herbal origins. In a report published in the New England Journal of Medicine this week, researchers from CDC and FDA made an estimation of emergency room visits to more than 23000 each year which are linked to consumption of dietary supplements about … Read more
Since the passage of the Compounding Quality Act in late 2013, compounding pharmacies have had a rough experience trying to comply with tough GMP rules. Of the almost 60 compounding pharmacies that voluntarily registered with the FDA, almost 50 have gone through FDA’s audit for GMP compliance and all but one were found to be in significant GMP violations and … Read more
Much needed major updates to the GCP guidance and the Common Rule were proposed by the FDA and DHHS recently. These changes are being proposed to modernize the regulatory requirements to match the current practices for clinical trials. In one of the most comprehensive updates to the human subject protection rules that apply to clinical trials funded … Read more
The “war” against high drug prices heats up even more this week when in a court filing Federal Trade Commission (FTC) strongly criticized practices used by the pharma companies to keep the drug prices high using questionable business and regulatory practices against generics. Pharma companies use two processes to increase the competitive advantage of their products over … Read more
Two articles in the British Medical Journal this week raise questions about the utility of FDA’s expedited approval programs such as breakthrough therapies and fast-track designations. The articles challenge if in its efforts to approve drugs fast, FDA is being lax in its safety and effectiveness analysis prior to approval. It is obvious from the review that … Read more
