With ANDA approval, one would expect that market entry would soon follow application approval, right? Wrong! The data suggests that only about 40% of generic drugs approved in any year are actually launched in that year and, after 5 years, there are still about 30% of those products that have still not launched. While this […]
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 […]
Last Friday (June 26, 2020), the Trump administration filed a legal brief with the U.S. Supreme Court requesting that the court find the Affordable Care Act (ACA) to be unconstitutional and, therefore, struck down in its entirety. Regardless of one’s opinion of the merits of the ACA to provide healthcare coverage for underprivileged Americans, there […]
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) […]
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 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 […]
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 […]
Oftentimes, we hear startling statistics that make us shiver and can cause a knee jerk reaction. Much has been written about the quantity of drugs that come from overseas, and the push for moving manufacturing of active pharmaceutical ingredients (API) and finished dosage forms (FDF) back into the U.S. While bringing jobs back to the […]
Today, the FDA announced (here) its Coronavirus Treatment Acceleration Program (CTAP), which is designed to use “every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful.” The FDA will continue to enhance this emergency program to bring safe […]
