We all know how to reset the clock at daylight savings time (albeit the first morning we may find ourselves a bit behind or ahead). We all know how and when to change our watches when we cross time zones. FDA now needs to find out how to reset the clock on several ANDAs, and […]
Once a vibrant means to bring various changes from a reference listed drug (RLD) to market, the ANDA suitability petition seems to have become the bottom of the totem pole, the last one in line, or a member of the forgotten world. As outlined under section 505(j)(2)(C) of the Federal Food Drug and Cosmetic […]
Just as the various User Fee Acts (UFA) go to congress for mark-up and reauthorization, a proposed administration budget contains a suggested doubling of fees charged for medical product reviews. Am I seeing this correctly? Industry and FDA have worked tirelessly over the last year and a half to get the various User Fee programs […]
OGD has revised its bioequivalence (BE) recommendation for rifaximin 200 mg and 550 mg tablets. Quite interestingly, the requirements for products that are qualitatively and quantitatively (Q1 & Q2) the same as the reference listed drug (RLD) will have a reduced burden and may eliminate conducting bioequivalence studies with clinical endpoints (albeit pharmacokinetic [PK] studies […]
We don’t like to mention specific products in this blog, so let’s just say an FDA panel yesterday gave a less-than-stellar review of the benefits of an abuse deterrent product by stating that the benefits of a firms’ long-acting opioid pain reliever no longer outweighed its risk. A crushing blow to the product for […]
First of all, this is not a political blog. Second, I am certain that someone will still think it is. Third, in this case, I do not care as I am an ex-FDAer that truly believes in the Agency and wants to see it succeed. I was rooting for Scott’s nomination for many reasons, […]
After yesterday’s post (here), final numbers for February are out and, while good, it was not the jump we have hoped for. The total approvals for February, 61, were very close to the 60 reported on the New and Generic Drug Approvals site for the month. This is the lowest discrepancy seen in many months. […]
Almost every health-related headline today mentions costs. Whether it be cost of health insurance, cost of hospital stays, doctor’s charges, and (of course) cost of drugs. While there are some shockers out there for drug costs, most are in line with expectations. One of the big problems is that even moderately priced drugs are most […]
Irritation has been building between the Office of Generic Drugs (OGD) and industry over the use of the terms backlog vs. workload, particularly over the last few months. At the recent Annual Meeting of the Association for Accessible Medicines (AAM), formerly the Generic Pharmaceutical Association (GPhA), the semantics pot almost boiled over. So why the […]
The FDA published a recertification of its Manual of Policy and Procedure (MaPP) titled, “Good Review Practices”, MaPP 6025.1 yesterday. The first iteration of this document was issued in 2006. This is its second recertification. In reviewing the document, I was reminded of several calls and discussions I have recently had with my industry colleagues […]
