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FDA Inspections: Lesson 1 – Interviewing Employees

The FDA Law Blog

Farquhar This is the first in a series of blog posts on tips for successfully handling an FDA inspection. Using publicly available examples, these lessons will illustrate potential pitfalls and strategies for interacting with FDA during and after an inspection. & Douglas B. FD&C Act 501(j).

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The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs

The FDA Law Blog

Karst The FDA Reduction-in-Force (Termination)or RIF(T)announced last week has resulted in countless stories in the press and on personal LinkedIn accounts from those RIFd. As folks steeped in the world of generic drugs And Hatch-Waxman know, theres a lot that happens before FDA can take action on an ANDA.

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Doctoring the Law: Congress May Let FDA Regulate the Practice of Medicine

The FDA Law Blog

Koblitz — Back in June, when Congress was negotiating the User Fee Acts, FDA asked Congress to add in some provisions reversing several lawsuits that it had just lost. Ultimately, FDA lost that fight, and a slimmed down version of the FDA Safety and Landmark Advancements (“FDASLA”) passed without those sections.

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Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development

The FDA Law Blog

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

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Final Rule for ACNU Arrives in Time for End of Year but Not Much New to Celebrate

The FDA Law Blog

Livornese As promised in the Fall Unified Regulatory Agenda, FDA issued the final rule to establish the pathway to obtain marketing approval of a nonprescription drug product with an additional condition for nonprescription use (ACNU) on December 26, 2024, before the end of the calendar year. By Deborah L. 105288 (Dec.

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FDA Finalizes Guidance Re Enforcement Policy for Homeopathic Drugs

The FDA Law Blog

By Riëtte van Laack — On December 7, 2022, FDA announced the availability of the final guidance regarding the enforcement policy for homeopathic drug products. This concludes FDA’s reevaluation of the regulation of homeopathic drugs which it started in 2015. FDA denied that petition in 2019.

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FDA Issues Two Guidance Documents on Food Allergen Labeling Requirements

The FDA Law Blog

Food and Drug Administration (FDA) issued two guidance documents, one draft and one final, on food allergen labeling requirements. 1, 2023; The applicability of food allergen labeling requirements to specific products (e.g., 1, 2023; The applicability of food allergen labeling requirements to specific products (e.g.,