FDA Law Blog
FDA Law Blog
3,996 FOLLOWERS
A blog by Food and Drug Attorneys at Hyman, Phelps & McNamara, P.C. Blog posts cover FDA News, Orphan Drugs, Animal Drugs & Feeds, cGMP Compliance, Dietary Supplements, Health Privacy, Reimbursement, and Orphan Drugs.
New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility
FDA Law Blog
by Kurt R. Karst
17h ago
By Adrienne R. Lenz, Principal Medical Device Regulation Expert & Kristy Katzenmeyer-Pleuss, Regulatory and Biological Safety Consultant ..read more
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GAO Report Recommends Retaining FDA’s Drug Inspectional Workforce As Agency Prepares for Trumpian Changes
FDA Law Blog
by Kurt R. Karst
2d ago
By John W.M. Claud & Mark I. Schwartz ..read more
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Evidence v. Belief: What a Kennedy Appointment Could Mean to FDA and Public Health
FDA Law Blog
by Kurt R. Karst
3d ago
By Jennifer D. Newberger & Jeffrey N. Gibbs ..read more
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Even in “Unprecedented” Times, There is Precedent
FDA Law Blog
by Kurt R. Karst
4d ago
By JP Ellison ..read more
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FDA and the Device Industry: Friends or Foes?
FDA Law Blog
by Kurt R. Karst
6d ago
By Jennifer D. Newberger ..read more
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MAHA, Nutrition, and the FDA
FDA Law Blog
by Kurt R. Karst
1w ago
By Ricardo Carvajal ..read more
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The Prophecy: How will the FDA under the New Trump Administration Handle OPDP Letters? (Jeff and Dara’s Version)
FDA Law Blog
by Kurt R. Karst
1w ago
By Jeffrey N. Wasserstein & Dara Katcher Levy ..read more
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FDA’s Proposal to Remove Oral Phenylephrine from the OTC Monograph Isn’t a Surprise but What is Left “Over-the-Counter”?
FDA Law Blog
by Kurt R. Karst
1w ago
By Deborah L. Livornese & JP Ellison ..read more
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Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development
FDA Law Blog
by Kurt R. Karst
1w ago
By Sarah Wicks & James E. Valentine ..read more
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To 513(g) or not to 513(g)? That is the question
FDA Law Blog
by Kurt R. Karst
1w ago
By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. Gibbs ..read more
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