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Under PDUFA V, FDA committed to obtain patient perspectives on at least 20 disease areas and their treatment options by the year 2017. The purpose was to include patient perspectives on their conditions, its impact on daily life, and available therapies for better patient-focused and patient-centric clinical trials. FDA committed to hold public meetings to … Read more

Sometimes you see a new guidance document from FDA and you scratch your head, trying to understand the intent of this new document and then it dawns on you; FDA is trying its best to help the novice sponsors understand internal processes. Last week, FDA released a new Guidance Document on best practices to discuss with FDA, … Read more

About three weeks ago, on 16th November 2014, FDA released an internal report highly critical of Lab Developed Tests (LDTs) using 20 such tests as examples. This report highlights several of FDA’s concerns regarding LDTs. According to this report, unregulated LDTs are dangerous to the public not only by giving false positive or negative results, but also … Read more

Scientific disputes are a common between sponsors and FDA reviewers. Most of the disputes occur because of interpretation of results of clinical and nonclinical studies and can be resolved with meeting the reviewers and addressing their concerns either by providing additional information or better explanation. But what should a sponsor do if there is continuing disagreement … Read more

In March of this year, FDA gave a Warning Letter to Kind LLC, the makers of Kind snack bars for use of the word “healthy” on the label of 4 of its products, among other things. FDA warned that the company does not meet the nutritional requirements defined in the law to legally call its products “healthy”. … Read more

FDA-regulated companies are subject to severe monetary and regulatory penalties when found to be non-compliant. In the last 10 years, fines of more than $20 billion were imposed just for off-label promotion by top 15 pharma companies. However, few individuals have been prosecuted, and very few senior executives have ever been personally accused of breaking the law … Read more

Three bioethicists, one each from NYU, Harvard and Yale, published a review of public reporting of clinical trial data used to support FDA approval by 10 major pharma companies of 15 new drugs in 2012. It was found that results from only about a third of the clinical trial trials were published. A total of 318 clinical … Read more

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