The Lachman Blog

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04
Aug

Responding to Consumer Complaints While Working with CMOs

Ricki Chase, M.S., Vice President, Lachman Consultant Services, Inc. (Lachman Consultants) and Carrie Colella, Senior Director, Lachman Consultant Services, Inc. (Lachman Consultants) take an in-depth look at the questions and challenges manufacturers face and how to respond to consumer product complaints while working with a contract manufacturing organization (CMO). The product, in this case, may […]

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03
Aug

OGD Updates June 2022 Statistics

With just three months left in FY 2022, the OGD provided its update, adding the rest of the June statistics.  We now have a full picture of the first three quarters of the metrics provided in the FDA Generic Drugs Program Activities Report – Monthly Performance. Here are some highlights of the complete June report […]

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02
Aug

More PSGs Added and Revised

Today in a prepublication Federal Register notice, (due to be published tomorrow), the FDA announced the addition of 29 new and 19 revised product specific guidance (PSG) documents.  The Agency acknowledges that, “as part of FDA’s commitments under the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II), FDA will publish guidances for reference […]

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27
Jul

Outsourcing Facility Fee Rates for Fiscal Year 2023 Announced!

Outsourcing facilties are compounding facilities that are registered by the FDA and subject to inspection.  The fee structure is rather simple, with facility fees and reinspection fees only.  The fee rates for FY 2023 will go into effect on October 1, 2022.  A chart comparing the FY 2022 and FY 2023 fees is provided below:   FY 2022 […]

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27
Jul

New Animal and Generic Animal User Fee Rates for FY 2023 are Barked Out Today

In the prepublication of the Federal Register this morning, the FDA announced the Animal Drug User Fee Rates (here) and the Animal Generic Drug User Fee Rates (here).  Some of the fees increased significantly while others decreased.  Fee variations are based on the projected number of applications, establishments, and products, as well as inflationary calculations. […]

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25
Jul

Two Numbers From 10 to 12 – What a Difference It Can Make!

For years, the FDA has been concerned about running out of numbers for the National Drug Code (NDC) to use to identify drug products. They estimate that their runway for exhausting all NDC number combinations may come in 10-15 years. Well, FDA published a proposed rule entitled Revising the National Drug Code Format and Drug […]

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22
Jul

Generic Drugs Quarterly Activities Report – Third Quarter FY 2022 Results

For each FY quarter, the OGD publishes a series of metrics (as agreed to in the GDUFA II commitment letter) that identify the FDA’s workload by indicating the number of ANDAs awaiting the OGD’s action, including new ANDAs submitted each month, with separate line‑items for tentatively approved (TAed) ANDAs awaiting approval (the FDA’s current ANDA workload) […]

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