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09
Jan
FDA Novel Drug Report for 2023 - Lachman Blog

FDA Novel Drug Report for 2023 Cites 84% First-Cycle Approvals – What about Generic Drugs?

The FDA report Advancing Health Through Innovation: New Drug Therapy Approvals 2023 (here) outlines the progress that the Agency has made on the approval of novel drugs (those “which are for therapies that have not previously been approved in the U.S.”), and provides a number of interesting statistics, so I urge you to read the […]

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08
Jan
Are Chromatograms Identified as “Incomplete Data” in Empower Really Incomplete

Are Chromatograms Identified as “Incomplete Data” in Empower Really Incomplete?

Have you ever found an Empower 3 chromatogram with no plot and the message “Incomplete Data”? You might have assumed that there was a system glitch, resulting in no data being acquired for the injection. However, data may have been acquired and can only be viewed if you have the appropriate permission(s). A search of the […]

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03
Jan

New End of FY 2023 Posting by OGD Takes Some Time to Figure Out

The FDA published the Generic Drugs Program 2023 Fiscal Year Web Posting (here) on December 28, 2023.  This document reflects the FDA’s performance for meeting GDUFA goal dates for FY 2023 submissions.  The document meets the required reporting of certain performance metrics as outlined in the GDUFA III commitment letter. Bravo to the OGD for getting the report […]

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02
Jan
Good Guidance Practices – FDA Wants Your Input_blogimage

Good Guidance Practices – FDA Wants Your Input!

In 2011, the FDA published the draft “Food and Drug Administration Report on Good Guidance Practices: Improving Efficiency and Transparency” (here) that established the way that the FDA would prioritize, develop, and release guidances in draft or final, and identified two levels of guidances, a so-called Level 1 and Level 2. A Level 1 guidance document is one […]

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27
Dec
Benzene - Lachman Consultants Blog

Direct Final Guidance on Reformulating Drug Products Containing Certain Carbomers Manufactured with Benzene

The FDA’s action is being taken to address a safety issue associated with the need to reformulate drug products that contain carbomers manufactured with benzene. The goal is to expedite and provide a clear and less burdensome path than might otherwise be required under the applicable Scale Up and Post Approval Changes (SUPAC) guidances for […]

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27
Dec
The Eyes Have it - Lachman Consultants Blog

The Eyes Have it!

On December 27, 2023, the FDA released a revised draft version of its October 2023 guidance titled Quality Considerations for Topical Ophthalmic Drug Products: Guidance for Industry. This revised draft, of the same name, outlines most of what was covered in the October draft guidance; however, it does include some clarifications and some additional information. The […]

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