FDA Law Blog

JANUARY 18, 2022

a traditional manufacturing site vs. the point of care); The capabilities available at a point-of-care healthcare facility can help mitigate production risks; Entities involved in 3D printing of devices should understand their regulatory responsibilities under the Federal Food, Drug, and Cosmetic Act; and.

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Manufacturing Regulation Compliance Production 98

FDA Law Blog

JULY 7, 2021

Walsh & Jeffrey N. Gibbs — In the first challenge ever brought against FDA’s rarely used power to ban a medical device, a court found FDA overstepped its authority and overturned the ban.

Regulation 52

Regulation Medicine Cosmetics Marketing 52

FDA Law Blog

JANUARY 18, 2022

a traditional manufacturing site vs. the point of care); The capabilities available at a point-of-care healthcare facility can help mitigate production risks; Entities involved in 3D printing of devices should understand their regulatory responsibilities under the Federal Food, Drug, and Cosmetic Act; and.

Manufacturing 75

Manufacturing Regulation Compliance Production 75

The Pharma Data

FEBRUARY 4, 2021

– Full-Year Global Net Revenues from the Aesthetics Portfolio Were $2.590 Billion; Global Botox Cosmetic Net Revenues Were $1.112 Billion. Global Botox Cosmetic net revenues were $493 million , an increase of 9.1 Botox Cosmetic*. – Reports Fourth-Quarter Diluted EPS of $0.01 percent on a reported basis, or 45.0

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Botox Production Sales Cosmetics 52

FDA Law Blog

JULY 8, 2021

By Jeffrey N. These criteria are by and large different from the ones found in the language of the Federal Food, Drug, and Cosmetic Act for determining device classification. Gibbs & Gail H.

Regulation 52

Regulation In-Vitro Production Genetics 52

FDA Law Blog

APRIL 23, 2021

Moore & Jeffrey N. Almost twenty years ago, two of the writers of this blog addressed that question in a law review article published by the Food and Drug Law Institute: Jeffrey N. 58 Food and Drug L.J. Blumberg, who was then the FDA’s Deputy Chief Counsel for Litigation, can be found at 58 Food and Drug L.J.

Drugs 40

Drugs Cosmetics Containment Production 40

The Pharma Data

APRIL 18, 2022

Food and Drug Administration issued a draft guidance that, when finalized, will outline the agency’s approach to evaluating the public health importance of food allergens that are not one of the major nine food allergens identified by law in the U.S (non-listed Today, the U.S. non-listed food allergens). Federal Register. Related Information.

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Allergies Cosmetics Production Drugs 52

FDA Law Blog

DECEMBER 22, 2022

By Jeffrey N. FDA , which held that that banning a single intended use of a specific device was inconsistent with the Federal Food, Drug, and Cosmetic Act’s (“FDC Act”) clear pronouncement that FDA cannot regulate the practice of medicine. Gibbs & Sara W. Circuit decision in Judge Rotenberg Educ.

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Regulation Medicine Doctors Doctor 114

FDA Law Blog

SEPTEMBER 22, 2022

By Jeffrey N. The drug and medical device industries present particularly compelling arenas in which to pursue deterrence through such prosecution because misconduct can carry high levels of public risk. Park, 421 U.S. 658 (1975)).

Cosmetics 59

Cosmetics Production Compliance Drugs 59

FDA Law Blog

MARCH 7, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. Section 3309 of the Food and Drug Omnibus Reform Act (FDORA), signed into law on December 29, 2022, amended section 738(a)(3)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding clause (ii) “Small business fee waiver.”

Manufacturing 64

Manufacturing Sales Cosmetics Regulation 64

FDA Law Blog

JUNE 21, 2022

Koblitz & Jeffrey N. Gibbs — There is a lot to unpack in the 430 pages of FDASLA, which means that some provisions are falling a little under the radar. One of those provisions is an unusual one in which Congress directs FDA to issue final rules concerning Over-the-Counter hearing aids.

Regulation 52

Regulation Licensing Licensing Sales 52

FDA Law Blog

NOVEMBER 1, 2023

Gaulkin & Jeffrey N. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Shumsky & Philip Won & Adrienne R.

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Regulation In-Vitro Manufacturing Licensing 81

Pharmacy Checkers

MARCH 11, 2020

Below is a copy of Gabriel Levitt’s comments on the FDA Notice of Proposed Rulemaking titled “Importation of Prescription Drugs” that were submitted Monday, March 9th, 2020. Comments on Notice of Proposed Rulemaking titled “Importation of Prescription Drugs, FDA-2019-N-5711, 84 Fed. FDA-2019-N-5711.

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Pharmacy Drugs FDA Approval Licensing 41