XTalks

JUNE 5, 2023

Ozempic and Wegovy, which contain the active ingredient semaglutide, were approved by the US Food and Drug Administration (FDA). Ozempic was approved for the management of type 2 diabetes mellitus in adults in addition to a reduced-calorie diet and exercise. The approved drugs contain the base form of semaglutide.

FDA Approval 98

FDA Approval Containment Drugs Pharmacy 98

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the PTO’s position and recent decisions on PTE applications for patents covering products approved—and then withdrawn years later—under the Federal Food, Drug, and Cosmetic Act’s Accelerated Approval provisions (and otherwise). exclusively licensed U.S. The PTE statute at 35 U.S.C. §

Marketing 59

Marketing Production FDA Approval Generic Drugs 59

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

XTalks

AUGUST 2, 2023

Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. It contains the antiviral medications nirmatrelvir and ritonavir. In addition, the FDA approved Pfizer’s pneumococcal 20-valent conjugate vaccine, Prevnar 20, for the first time in June 2021.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

Advarra

JULY 19, 2022

The sponsor-initiated IND is conducted by a pharma company seeking commercial approval. Q: When you want to do a study of an FDA-approved drug under an investigational indication, is an IND still required or can you seek an exemption? Then you can submit an application for approval. Q: What is the definition of a drug?

Packaging 52

Packaging Packaging Drugs Containment 52

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. 21 U.S.C. § 802(16)(B). chemotherapy-induced), pain, and post-traumatic stress disorder.

FDA Approval 69

FDA Approval Drugs Containment Cosmetics 69