XTalks

JUNE 5, 2023

During a drug shortage, compounders might be allowed to prepare a compounded version of the drug provided they meet specific requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act. Novo Nordisk, the pharmaceutical manufacturer of Ozempic and Wegovy, is actively addressing these supply challenges.

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

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Palmer — Last week FDA published a long-awaited Draft Guidance for outsourcing facilities addressing the Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Draft Guidance).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 Draft Guidance III.B.2(e)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

Advarra

JULY 19, 2022

Also consider quality agreements for key vendors, such as contract development and manufacturing organizations (CDMO) and CROs. Do you search for similar products, and use existing IND criteria requirements against the latest manufacturing guidance docs? Then you can submit an application for approval.

Packaging 52

Packaging Packaging Drugs Containment 52

XTalks

AUGUST 2, 2023

Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDA approval on May 25, 2023. The FDA approved the drug over a decade ago in September 2009.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

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)(A). 21 U.S.C. § 802(16)(B). chemotherapy-induced), and pain.

FDA Approval 69

FDA Approval Drugs Containment Cosmetics 69

XTalks

JANUARY 11, 2024

The US Food and Drug Administration (FDA) has given authorization to Florida’s Agency for Health Care Administration’s drug importation program under section 804 of the Federal Food, Drug and Cosmetic Act (FD&C Act). This means Florida could soon import select prescription drugs from Canada.

Drugs 69

Drugs Cosmetics Medicine FDA Approval 69