Regulatory

FDA Makes Low-Risk Determination for Marketing of Products from Genome-Edited Beef Cattle After Safety Review

U.S. Food and Drug Administration

Improving the Handling and Safety of Pharmaceutical Raw Materials Through Dry Granulation

Thomas Briel, Ph.D.; Moritz Beck-Broichsitter, Ph.D.

MilliporeSigma

Process Development

Designing More Sustainable Small Molecule API Manufacturing Processes

Marko Salo; Arne Grumann

Fermion

Fecal Transplant

Fecal Transplant Associated with One Patient Death

David Alvaro, Ph.D.

Pharma's Almanac

FDA Action

FDA Orders Manufacturers of Surgical Mesh Intended for Transvaginal Repair of Pelvic Organ Prolapse to Stop Selling All Devices

U.S. Food and Drug Administration

Safety Labeling

FDA Orders Important Safety Labeling Changes for Addyi

U.S. Food and Drug Administration

FDA

Statement from FDA on the Agency's List of Known Nitrosamine-free Valsartan and ARB Class Medicines

U.S. Food and Drug Administration

Public Health

FDA and CBP Bolster Collaboration to Protect Public Health and Safety

U.S. Food and Drug Administration

Stem Cells

Statement by FDA on Efforts to Stop Stem Cell Clinics and Manufacturers from Marketing Unapproved Products and Advance Legitimate Development

U.S. Food and Drug Administration

Drug Safety

BioIVT Launches Its XPRESSWAY® Profile Safety Package, a Gene Expression Reference Guide Designed to Improve Drug Safety Analyses

BioIVT

Quality Metrics

FDA Makes More Quality Moves

Nigel Walker

Nice Insight