User Fees

14
Mar

OTC User Fee Rates Published Today

The FDA published the OTC User Fee rates for FY 2022 today  These rates were announced this morning in a Federal Register notice (here) and cover fees for OTC manufacturing facilities, contract manufacturing organizations (CMO), and OTC monograph order requests (OMOR) for which there are tier 1 and tier 2 requests.  A comparison of the FY […]

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31
Oct

OGD Published GDUFA III Commitment Letter

Every 5 years, the user fee programs (UFAs) are renegotiated and, for each UFA program, there is a commitment letter that outlines the agreed-upon goal dates and program enhancements that will dictate the five-year reauthorization period when Congress passes the Reauthorization Act (likely in mid to late FY 2022). This is a piece of must-pass […]

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14
Sep

Whoops, Lots of OTC Manufacturers Missed the Deadline – FDA Releases OTC Arrears List

The FDA published its first arrears list for failure to pay FY 2021 Over-the-Counter Monograph User Fee Act (OMUFA) facility fees.  Invoices were emailed on June 25, 2021 for fees not paid by the May 10, 2021 due date.  And, holy smokes, there are almost 500 firms on the arrears list.  Twenty‑eight are contract manufacturing organizations […]

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17
Mar
Rough roadway

Update on Meeting CDER User Fee Goals During Pandemic – Not Too Bad!

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 […]

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