Camargo

DECEMBER 13, 2021

Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act.

Development 161

Development Production Immune Response Licensing 161

FDA Law Blog

MARCH 13, 2024

Part 2 (“Part Deux”) investigated the PTO’s position and recent decisions on PTE applications for patents covering products approved—and then withdrawn years later—under the Federal Food, Drug, and Cosmetic Act’s Accelerated Approval provisions (and otherwise). Lehman , No. 95-650-A (E.D. . 10,544,220 (the ‘220 patent).

Marketing 59

Marketing Production FDA Approval Generic Drugs 59

Roots Analysis

JANUARY 3, 2024

Medical aesthetics is a growing area of modern medicine that focuses on improving the cosmetic appearance of an individual through various medical treatments. However, Botulinum toxin was the real game-changer when it was approved for cosmetic use by the FDA in 2002.

Filler 40

Filler Cosmetics Production Dermatology 40

FDA Law Blog

JULY 5, 2023

Palmer — Last week FDA published a long-awaited Draft Guidance for outsourcing facilities addressing the Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Draft Guidance). See 21 U.S.C. 353b(a). Section II at 2. Draft Guidance III.B.2(e)

Drugs 52

Drugs Production Manufacturing Licensing 52

FDA Law Blog

FEBRUARY 29, 2024

As FDA explains on its website (which includes lists— here and here —of the more than 300 Accelerated Approvals (and withdrawals)): The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint.

Production 59

Production Drugs FDA Approval Compliance 59

FDA Law Blog

JANUARY 18, 2024

Rescheduling Analyses, 2016 DEA noted in 2016 that a drug had a currently accepted medical use for purposes of the CSA if it was the subject of an approved new drug application (“NDA”) under the Federal Food, Drug and Cosmetic Act. chemotherapy-induced), pain, and post-traumatic stress disorder. chemotherapy-induced), and pain.

FDA Approval 69

FDA Approval Drugs Containment Cosmetics 69

XTalks

AUGUST 2, 2023

Join us as we present an in-depth analysis of each company’s revenue, net income, R&D investments, core therapeutic areas, market presence and strategic collaborations. is a global pharmaceutical company, working across both developed and emerging markets. The FDA approved the drug over a decade ago in September 2009.

Sales 98

Sales Manufacturing FDA Approval Life Science 98