FDA Related News

FDA General

Product Approval Summaries

FDA Review posts product approval summaries for the week ending 3/1/2019.

Human Drugs

Guide on Bulk Drug Substances for Compounding

FDA issues a final guidance on Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and C...

Federal Register

Comments Sought on Cannabis Scheduling Recommendations

Federal Register notice: FDA seeks comments on World Health Organization recommendations to impose international manufacturing and distributing restri...

Human Drugs

FTC Settlement Over AndroGel Generics

The FTC reaches a settlement in FTC v. Actavis, a 2009 case alleging that Solvay and three generic drug companies illegally agreed to restrict generic...

Federal Register

Comments Sought on Fentanyl Scheduling Recommendations

Federal Register notice: FDA is seeking comments on World Health Organization drug scheduling recommendations on fentanyl-related narcotic drugs.

Human Drugs

AurobindoPharma Expands Recall of Valsartan Products

AurobindoPharma expands a 12/2018 recall to include 38 lots of valsartan and amlodipine and valsartan tablets after detecting trace amounts of a human...

Human Drugs

FDA Warns CanaRx Over Unapproved Drugs

FDA issues a Warning Letter to CanaRx for causing the distribution of unapproved new drugs and misbranded drugs to U.S. consumers.

Human Drugs

Pulse Biosciences 510(k) for CellFX System

Pulse Biosciences files a 510(k) for the energy-pulse CellFX System for use in common dermatologic procedures.

Human Drugs

Adlon Therapeutics ADHD Drug Approved

FDA approves an Adlon Therapeutics 505(b)(2) NDA for Adhansia XR (methylphenidate hydrochloride) extended-release capsules for treating attention-defi...

FDA Lacks Resources for Stem Cell Regulation: Report

The Washington Post details problems with umbilical cord injections from Liveyon and FDAs inability to adequately regulate the growing stem cell indus...