Just nine (9) days ago, I posted a blog and article (here) on the issue of paper prescribing information – package inserts! The overall takeaway was that FDA is ready to move on this issue. There was a proposed rule sitting dormant, because every year since its proposal, e Congress has included a provision in […]
Once an approved NDA product is discontinued from marketing or withdrawn, the FDA must make a determination that the reason for such action by the innovator was not for safety or efficacy reasons (see 21 CFR 314.161(a)). Such a determination must be made before an ANDA for a duplicate of the reference listed drug (RLD) […]
As we all know, the pandemic has wreaked havoc with inspections of drug manufacturers, API manufacturers, and laboratory facilities, as well as inspection of clinical study sites. Remote working, meeting problems, and just general pandemic fatigue has hindered some of the FDA’s work. However, the statistics are not as bad as one might think, all […]
For those of you that are not directly in the pharmaceutical industry or who are not healthcare providers, you may wonder why the FDA is having a meeting to discuss the morphine milligram equivalents for other opioids. Well, I know that measure gives healthcare providers a good idea of how to transition patients taking morphine […]
With the number of emergency use authorizations (EUAs) for drugs, devices, and biologics numbering in the hundreds and the relaxed enforcement policy on certain OTC products, the Agency will have a lot to do once the pandemic is over. FDA will need to decide whether to grant final clearance or approval to a ton of […]
On January 14, 2020, we posted a blog (here) concerning a Drug Safety Communication discussing FDA’s concern that the drug product Belviq or Belviq XR (lorcaserin) could increase the risk of cancer. On September 16, 2020, we posted a blog noting FDA’s final action withdrawing the 2 NDA drug applications for the product mentioned above […]
In a prepublication of a Federal Register notice (here) that will publish on March 3, 2021, the FDA has announced its intention to refuse to approve the 505(b)(1) NDA originally filed by Sanofi and now held by Lexicon Pharmaceuticals for Sotagliflozin Oral Tablets, 200 mg and 400 mg. The product was intended to be indicated […]
When FDA approved the Pfizer drug product tofacitinib (Xeljanz, Xeljanz XR), which treats arthritis and ulcerative colitis by decreasing the activity of the immune system, they required that Pfizer conduct post-approval safety trials to evaluate the risk of serious heart-related events, cancer and infections. Tofacitinib is offered in two strengths which were both studied in […]
Looks like we all will be doing a lot of reading and assimilation of new information in 2021. The CDER Guidance Agenda – New & Revised Draft Guidance Documents Planned for Publication in Calendar Year 2021 contains 105 new and revised guidance documents that CDER plans to release this year. While there are a number […]
While reading a blog post by Michael Mezher of RAPS this morning, entitled HHS Pushes Through Last-Minute Policies Impacting FDA (here), it struck me that my own age old question is almost (and I stress almost) being addressed. The question is, when a regulation or statute directs the FDA to meet certain review timeline requirements, […]
