FDA Law Blog

MARCH 4, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Deborah L. Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act.

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Manufacturing Supply Chain Provider Treatment Plan 59

FDA Law Blog

JANUARY 9, 2025

Although FDA has long taken the position that it has broad authority in how it conducts its inspections, it was not until 2012 that Congress put some teeth behind FDAs policy position. FD&C Act 501(j). But what exactly constitutes delaying, denying, limiting or refusing an FDA inspection?

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FDA Law Blog

APRIL 8, 2024

For generic drug manufacturing facilities specifically, the numbers are 63% and 87%. The proposed Manufacturing Resiliency Assessment Program (MRAP) would be managed as a public-private partnership and would assign resilience scores to manufacturers of generic drugs, “based on an assessment of manufacturer practices and past performance.”

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GeriPal

MARCH 2, 2023

It’s not a controlled substance medication. Eric: So I heard gabapentin is the 10th most commonly prescribed medication in the US. In psychiatry, a lot of the anti-epileptic medications, we call them mood stabilizers and are used in bipolar disorder. Eric: Are these generic? Nisha: Both of them are generic, yeah.

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FDA Law Blog

FEBRUARY 4, 2025

This time, however, the program, which has helped incentivize the development of dozens of pediatric rare disease therapies since 2012, was not renewed. The authors suggested that the developers of such therapies would receive a priority review voucher that they can sell to manufacturers of blockbuster drugs.

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IT Vaccination Manufacturing Medical 52