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 […]
Just look around, watch the television, read the newspaper, and what do you see? Seems like very few reasons to be thankful. School and workplace shootings, the political scene is as nasty as I ever remember in my 70 years on earth. Climate change is threatening the future of our children, and the environmental controls […]
Today, the FDA issued Revision 1 to the above-referenced guidance. According to the Federal Register notice announcing the availability of the revision, “[T]he draft guidance announced in this notice revises and replaces the draft guidance for industry on ‘Assessing User Fees under the Generic Drug User Fee Amendments of 2017.’ This draft guidance addresses changes […]
It has been a while since the FDA updated its guidance on PDUFA fee waivers, etc., but the newly released Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products document provides much needed new information about the FDA’s fee program. The Federal Register Notice (here) announcing the availability of the […]
In a series of four Federal Register Notices issued today, the FDA announced the fee structures for the last four UFAs for Fiscal Year 2020. It is no surprise that the PDUFA fees are the highest overall in total, with well over $1 billion in potential collections. The fees for each of the programs are […]
In two separate Federal Register notices (here for medical devices and here for outsourcing facilities), the FDA announced the user fee amounts for FY 2020. The FDA notes that the fees are effective on October 1, 2019 (the beginning of the 2020 FY) through September 30, 2020. The medical device fees are provided in the […]
The unprecedented length of the government shutdown has a lot of people scratching their heads about lots of things. From a personal perspective, I have heard that FDAers are still getting paid (Commissioned Corps and civil servants) but the unknown is, for how long? When will the user fee money really run out? Has FDA […]
To all of our readers – Have a happy holiday season and a very happy, healthy, and prosperous New Year. The Lachman blog will be taking a break over the holiday starting Friday, December 21st (unless something extremely urgent occurs) and I hope that all of you will rejoin me in the New Year as […]
I just read the Association for Accessible Medicines’ (AAM) White Paper entitled “Ensuring the Future of Accessible Medicines in the U.S., Avoiding Shortages & Ensuring Competition for America’s Patients” (here) that is being entered into the record at the FDA-sponsored meeting Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions held on November […]
