The FDA released an updated version of its Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry as Revision 2. Originally issued in 2015 (here) and updated again in 2019, the June 2020 version contains much the same information but provides updates as to timetables, additional categories of PAS, CBE, and CBE 30 […]
Today, the FDA posted MaPP 5220.2 (here), which outlines a little-known process (because it so seldom happens) that describes how the Agency will go about converting an ANDA approval to a tentative approval (TA). The issue only occurs when a patent challenge is won by the innovator after the expiration of the thirty-month stay and […]
I know that I have written about this issue multiple times (here and here; also search our blog for other data integrity posts) and I guess it is a holdover from my time at FDA and living through the generic drug scandal of the late 1980s, but, come on now, folks, the FDA’s bark seems […]
The FDA released a guidance to remain in effect until the COVID-19 public health emergency is resolved titled Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications — Questions and Answers ( here). In this guidance, the Agency addresses many questions they have been asked about scheduling meetings, face-to-face (FTF) […]
A recent court case and FDA win (here) provides the backdrop for a peek at some of the risks of a 505(b)(2) NDA applicant seeking to gain approval for an abuse deterrent opioid formulation or product. The basic issue, from a layman’s perspective, is that a firm submitted an NDA (likely a 505(b)(2) application) for […]
The FDA has sent a “Dear Colleague” letter (here) to NDA holders to get ready for the start of FY 2021 on October 1, when the program fees (previously called “product fees” in previous iterations of PDUFA) will be due for each product (up to 5 in each application) marketed by the application holder. The […]
In early April, Contract Pharma published an article addressing what you need to know prior to submission. The author, Michelle Ryder, Principal Consultant in the Regulatory Practice of Lachman Consultants, explains “there are a few avenues FDA has opened to get to your destination of knowing what you need to know prior to submission.” How […]
In a post entitled The Path Forward: Coronavirus Treatment Acceleration Program (here) penned by FDA Commissioner Steven Hahn, CBER M.D., Director Peter Marks, M.D., Ph.D., and CDER Director Janet Woodcock, M.D., the FDA describes the accelerated actions the Agency is taking to move the most promising therapeutic treatments to patients as quickly as possible. Just […]
The FDA posted a notice indicating that they continue “to investigate the presence of the N-Nitrosodimethylamine (NDMA) impurity in ranitidine and is now aware of NDMA in nizatidine, which is chemically similar to ranitidine.“ They have found levels on NDMA in one company’s product that exceed the accepted limits and that company has initiated recall […]
On April 7, 2020, FDA released a Q&A on manufacturing and supply change requests related to COVID-19 and drug shortages. In this Q&A, FDA provided the following guidance: Manufacturing site changes because of supply chain disruptions related to COVID-19 – If the site change is for treatment of patients with COVID-19 or for drugs […]
