Some time ago, we highlighted the issues that we had been facing searching FDA’s Warning Letter database in the new FDA website (FDA’s Website Re-Design – Did Something Get Left Behind?). We wanted to give you an update as to where the current status of this is. Since drafting this post, we received some email […]
February 3, 2020 was the last day to comment on the Food and Drug Administration’s (FDA) notice in the Federal Register on the Novel Excipient Review Program Proposal; Request for Information and Comments (here), which we reported on in a previous blog post (here). In this notice, the FDA had proposed a pilot program related […]
On February 4, 2020, FDA issued a press release regarding the issuance of an emergency use authorization (EUA) (here) to allow for emergency use of a Coronavirus diagnostic panel by Centers for Disease Control and Prevention (CDC)-qualified labs across the country. Previously, the panel’s use was limited to only CDC laboratories. This additional step […]
Recently, FDA has posted (here) that Metformin, from several sources, tested by FDA showed that the levels of N-nitroso-dimethylamine (NDMA) in the drug are below the levels of detection (here). Great news! NDMA belongs to the nitrosamine family, and is one of the well-known animal carcinogens and a suspected human carcinogen. The nitrosamines, including NDMA, […]
The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued a joint statement on Monday, February 3, 2020 (here) regarding their collaborative plans to advance competition in the biologics market. This joint effort is intended to address misinformation and anti-competitive behavior that may impede competition between biologic drug products. A significant focus […]
As of February 4, 2020, there have been 49 full approval actions and 13 tentative approval actions posted for January 2020. As always noted, these number come from the available data on FDA’s All Approvals site (here) and FDA’s Recent New and Generic Drug Approvals list which is updated daily (here). The official numbers will […]
The FDA released its most current version, its “Guidance Agenda: New & Revised Draft Guidances: CDER Plans to Publish During Calendar Year 2020,” yesterday and there are some interesting things for generic and new drugs. The complete document can be viewed here, but we will highlight some of what we believe might be the most […]
If you are, or plan to be a sponsor of a Generic ANDA, do not let this slip by you. The FDA on January 30, 2020 revised its Manual of Policies and Procedures (MAPP) 5240.3, Prioritization of the Review of Original ANDAs, Amendments, and Supplements to make changes to the prioritization scheme for the review […]
The Office of Generic Drugs (OGD) updated its December 2019 (first quarter FY 2020) statistics with metrics, in addition to the approvals, receipts of original ANDAs, and complete response letters that were published a few weeks ago. The OGD reported refusing-to-receive (RTR) four ANDAs, three standard review and one priority review application. While four is […]
Many years ago, I wrote an article on the influx of Pharmacy Benefits Managers (PBMs) on the cost of prescription drugs (this was before much was really known about how they operated). In that article, I opined that I thought that they would be a great benefit to organizations that were not big enough to […]
