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 ...
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.
Becker's Hospital Review

FDA eases approval path for cell, gene therapies

The FDA has updated guidance outlining how it applies regulatory flexibility to chemistry, manufacturing and control requirements for cell and gene therapies. The agency said the approach is meant to ...
al.com

The FDA is pausing milk quality testing: Here’s why

The U.S. Food and Drug Administration has suspended its quality control program that tests dairy products, including milk. USA TODAY reports the agency’s Food Emergency Response Network Proficiency ...
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, ...
GlobalData on MSN

FDA and EMA release collaborative AI framework for drug development

"FDA and EMA release collaborative AI framework for drug development" was originally created and published by Clinical Trials ...
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 ...
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.
KSL

FDA suspends milk quality tests amid workforce cuts

WASHINGTON — The Food and Drug Administration is suspending a quality control program for testing of fluid milk and other dairy products due to reduced capacity in its food safety and nutrition ...
Inquirer.net on MSN

FDA: Lack of food safety limits not a 'shield against accountability'

The Food and Drug Administration (FDA) on Tuesday warned manufacturers that the lack of specific safety limits cannot be used ...
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 ...