Revision to the Guidance “Assessing User Fees Under the Generic Drug User Fee Amendments of 2017”

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  According to the Federal Register notice announcing the availability of the revision, “[T]he draft guidance announced in this notice revises and replaces the draft guidance for industry on ‘Assessing User Fees under the Generic Drug User Fee Amendments of 2017.’  This draft guidance addresses changes in user fee assessments from GDUFA I,

Terms and conditions text in legal agreement or document about service, insurance or loan policy.

New FDA Guidance on PDUFA Fee Waiver, Reductions, and Exemptions Issues

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 guidance states:

“This guidance describes the types of waivers,

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FDA Announces MDUFA and Outsourcing User Fee Rates for FY 2020 – All Fees Higher

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 charts below,

The 20-Day Window Catch – How Will It Play Out? and Other Questions

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 been able to use the money that they collected for the applications submitted between October 1,

Happy Holidays from Us to You!

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 we follow the ever-changing landscape of FDA regulatory science,

Did Someone Forget User Fees?

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 27th in Washington DC.