A new draft guidance titled (quite originally) Drug Master Files (here) has replaced the Drug Master Files: Guidelines that was published in 1989. There have been many changes to the requirements and procedures for DMFs based on new laws, policies, and procedures, as well as procedures associated with GDUFA commitment letters for ANDAs, and (of […]
For the first time since GDUFA’s beginning, the number of ANDA approval actions exceeded the number of ANDAs received in a given FY (935 approvals vs 909 new ANDA receipts). In addition, OGD smashed the FY approval record with the 935 approval actions by 154 (or 16.5%) more than the previous record of 781 in […]
At the end of August, we noticed that all of the ANDA approvals were not appearing on the FDA Daily Approval Listings (here), nor were they appearing on the FDA All Approvals Report (here). In September, it got worse, with less than half of approvals showing up (we believe). It appears that the problem has […]
August saw the OGD refusing to receive only three applications, one standard application and two priority GDUFA II applications. Quite interestingly, thus far this FY, the number of priority-review applications compared to the number of standard-review ANDAs that have been refused to be received (10/37) is quite high considering that there are many more standard-review […]
In a short Warning Letter issued by the FDA on August 29, 2019, the Agency informed a China-based testing firm that, because it refused inspection, that FDA would withhold approvals of any ANDA or NDA in which it was cited as a testing laboratory. The FDA takes refusal of inspection very seriously and the impact […]
After a few inquiries about the lack of public approval action reporting for ANDAs at the end of August and thus far through September 25th, it appears that our reporting revealed some type of a problem. Although we do not know the exact nature of the problem as of yet, we received a nice note […]
Sue Sutter of the Pink Sheet wrote an article on September 23 entitled “Makena’s Accelerated Approval Will Hang In Balance at US FDA Panel Meeting In October” (here [subscription required]). The crux of the article deals with how FDA will handle accelerated approval when the required postmarketing confirmatory study fails to meet its endpoints. Ms. […]
Not wanting to really say we saw this coming, but in a blog post in October 2014 (here), we postulated that the abuse-deterrent aspect of other classes of drugs that have abuse potential would likely be become targets as time passed. In a Federal Register Notice (here), this prediction made in 2014 appears to be […]
I have blogged about a problem with the discrepancy in the official August approval numbers that the FDA issues in its Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance (Report) (here) and those appearing on the FDA daily approval list (here) and the FDA All Approvals list (here). The latter two listings […]
This guidance (here) finalizes the draft guidance for industry entitled “Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act” issued in October 2018 and supersedes the Guidance by the same name issued in November 2014. The guidance document revision is based on comments that […]
