There are numerous FDA-approved combination cough syrups on the market. In addition, Codeine with Guaifenesin is an OTC monograph product that can be sold without prescription in many states. The use of these products in pediatric patients (under 18 years of age) can cause breathing and respiratory problems.
June 2015 saw the largest number of approvals in a single month since the start of GDUFA, at 57 full approvals and 10 tentative approvals, while receipts were a meager 37. This reverses a long trend of receipts outpacing approvals and represents a month where the backlog actually has an absolute decrease of at least 30 applications.
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 […]
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.
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.
While I rarely use others’ comments in full to populate this blog, I think that Ralph Neas, President and CEO of GPhA, said all that needs to be said on the state of GDUFA and the hope for future improvements – so here is.
