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FDA Law Blog

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FDA Law Blog is where experts go to learn about the FDA. Hyman, Phelps & McNamara has its finger on the pulse of the FDA and extensive experience with the universe of issues faced by companies regulated by FDA.

FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway

FDA Law Blog

by Kurt R. Karst

18h ago

By Charles G. Raver & James E. Valentine & Ellis Unger & Frank J. Sasinowski ..read more

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FDA Inspections: Lesson 1 – Interviewing Employees

FDA Law Blog

by Kurt R. Karst

2d ago

By Anne K. Walsh & Paul M. Hyman & Douglas B. Farquhar ..read more

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What’s in a Claim? The Federal Circuit Rules on Orange Book Patent Listings

FDA Law Blog

by Kurt R. Karst

4d ago

By Sara W. Koblitz ..read more

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

FDA Law Blog

by Kurt R. Karst

1w ago

By Deborah L. Livornese ..read more

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FDA’s Final Rule on the Implied Nutrient Content Claim “Healthy” Maintains Focus on Foods Rather than on Nutrients

FDA Law Blog

by Kurt R. Karst

1w ago

By Riëtte van Laack ..read more

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Saving the Skinny Label Through the Skinny Label, Big Savings Act

FDA Law Blog

by Kurt R. Karst

1w ago

By Sara W. Koblitz ..read more

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The Sun Has Started to Set on the Rare Pediatric Disease Priority Review Voucher Program – But It Can Still be Saved

FDA Law Blog

by Kurt R. Karst

3w ago

By Mark A. Tobolowsky & Frank J. Sasinowski ..read more

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FDA’s Third Party Review Program is Ready for the Next Pandemic, not the LDT Final Rule

FDA Law Blog

by Kurt R. Karst

3w ago

By Adrienne R. Lenz, Principal Medical Device Regulation Expert ..read more

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FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What CMC Questions Did They Answer? (Part 2)

FDA Law Blog

by Kurt R. Karst

3w ago

By Richard A. Lewis, Senior Regulatory Device & Biologics Expert & James E. Valentine ..read more

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Prehearing Ruling Establishes Marijuana Rescheduling Hearing Ground Rules

FDA Law Blog

by Kurt R. Karst

1M ago

By Larry K. Houck ..read more

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