The Lachman Blog

07
Mar

FDA Announces Dietary Supplement List

In recent years, there have been endless FDA actions on adulterated and/or misbranded dietary supplements. In addition, almost every week, there are warning letters or FDA public health announcements regarding dietary supplements released by the Agency. The FDA does not approve dietary supplements, but they do regulate them.  This is a confusing area for the […]

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06
Mar

January 2023 Official Statistics – and Yes, I Am a Bit Confused

When we reported the unofficial January approval actions in a previous blog post,  there was some concern about how OGD would be reporting their approval and tentative approval actions on the daily report versus the Generic Drugs Program Monthly and Quarterly Activities Report (here). If you go back and read the January unofficial approval blog […]

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03
Mar

REMS Bill – Is It Really the Answer?

The Hill report (here) that “Sens. Maggie Hassan (D-N.H.) and Mike Braun (R-Ind.) on Wednesday reintroduced legislation intended to close a loophole that drug companies can exploit to block competition, including from lower-cost generic drugs.”  The bill would permit FDA to approve a drug product for a generic immediately if all other approval requirements are […]

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03
Mar

ICH Q13 – Continuous Manufacturing of Drug Substances and Drug Products

CDER has issued the final guidance, ICH Q13 Continuous Manufacturing of Drug Substances and Drug Products, which provides for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM), applying to both drug substances and drug products for chemical entities, therapeutic proteins for new products, and conversion of existing products.  A copy of the guidance […]

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24
Feb

Discontinued Chantix – FDA Says Not for S&E Reasons

When a reference listed drug (RLD) product is discontinued from marketing, or if the RLD’s NDA application is officially withdrawn, we all know that the FDA must make a determination that the specific RLD was not discontinued from marketing or withdrawn for safety or efficacy reasons before it can approve an ANDA based on the […]

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