FDA finds repeat quality failures at Houston's Empower Pharmacy in latest inspection, records show

The repeat problems at Houston-based Empower Pharmacy include inadequate quality testing and a failure to clean equipment.
Earth.com

FDA issues nationwide recall for a widely-used nasal spray

The FDA orders the recall of a nasal spray in the US after finding live microbes; immunocompromised patients are at greatest ...
Healio

FDA grants breakthrough designation to ianalumab for Sjögren’s disease

The FDA has granted breakthrough therapy designation to Novartis’ ianalumab for Sjögren’s disease, according to a press release from the manufacturer.In its statement, Novartis said it plans to submit ...
GlobalData on MSN

FDA increases manufacturing flexibility for cell and gene therapies

Clinical and commercial quality controls are eased as the FDA looks to expedite therapy approvals in areas of unmet need.
MM&M

The FDA often doesn’t test generic drugs for quality concerns, so ProPublica did

This article originally appeared on ProPublica. It’s a fundamental tenet of health care in America: Generic drugs are just as safe and effective as brand-name ones. The only difference is the price.
JD Supra

FDA Identifies Data Quality and Study Conduct Concerns With Raptim Research and Requires Sponsors to Submit Replacement Study Data

The FDA recently announced that it had identified “significant data integrity and study conduct concerns” in various bioequivalence studies conducted by the India-based contract research organization, ...
NBC Chicago

FDA pauses milk quality testing program due to reduced capacity

NBC 5 Responds has confirmed the Food and Drug Administration has paused a program used for testing quality of fluid milk and other dairy programs. An internal email seen by Reuters said this was due ...
GlobalData on MSN

FDA and EMA release collaborative AI framework for drug development

The joint guidance was created to ensure drug developers employ best practices when using AI.
Forbes

We Import Too Many Substandard Generic Drugs: Five Steps To Safety

Generic drugs account for more than 90 percent of prescriptions filled in the United States. Recent studies have found concering variability in quality and safety America’s generic drug supply, most ...
CURE

FDA Orphan Drug Designation Granted to Zavabresib for Myelofibrosis

The FDA granted orphan drug designation to zavabresib, an investigational therapy for the treatment of myelofibrosis, a rare ...
JD Supra

FDA finalizes computer software assurance guidance for production and quality system software

The U.S. Food and Drug Administration (FDA) recently finalized its guidance document, Computer Software Assurance for Production and Quality System Software, for software used in device production and ...