With the first quarter of GDUFA 2015 and metrics behind us, we are seeing what FY 2015 may have in store for us, and importantly, we have observed that (at least right now) you cannot always believe all of the numbers you see.
For years, FDA has been indicating that it was planning to take enforcement action against certain marketed unapproved prescription and OTC ear drops, but, yesterday, the final shoe dropped on the marketing of such products, as FDA published its intent to take enforcement action against these products in a Federal Register notice (here). The FDA […]
FDA first released its guidance on Controlled Correspondence Related to Generic Drug Development in August 2014. We previously blogged about this guidance (here). In today’s Federal Register notices, FDA provided its response to comments received on the Guidance document.
In the latest salvo fired over the controversial FDA proposed rule that would permit generic drug ANDA holders to unilaterally change their drug product warnings, Senator Lamar Alexander, Ranking Member, Committee on Health, Education, Labor & Pensions and Congressman, and Bob Goodlatte, Chairman of the Judiciary Committee asked the Office of Management and Budget’s Administrator of the Office of Information and Regulatory Affairs (OIRA) to explain a few things about the FDA position.
The buzz about abuse-deterrent opioids (no pun intended) in some camps seems to view these products as a panacea for the prescription drug abuse problem. In my view, that is far from the reality of the problem and clearly miles from the solution.
In response to stakeholder requests, the FDA has delayed the enforcement date only for dispensers under the Drug Supply Chain Security Act (DSCSA) until November 1, 2015.
The FDA has posted a Drug Safety Podcast on its website (here) that describes an adverse drug event (ADE) associated with use of a drug indicated to treat attention deficit hyperactivity disorder (ADHD).
After reading a nice blog post by Kurt Karst and Josephine Torrente on the FDA Law Blog (here) on a push to release Complete Response Letters (CRL), I thought to myself (at first),
The FDA is looking for a few (or a lot) more good employees and is holding another virtual hiring event. Could FDA be looking to obligate a portion of the $277 million excess of GDUFA funds that have not yet been spent from the fees collected in the first 2.5 years of the program?
Not surprisingly, the FDA said they were doing the best that they could with a new program, and industry said, so far, not good enough. While these may seem like diametrically opposed views, my understanding is that the apparent positions are not as far apart as they might appear.
