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 ...
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 ...
Applied Clinical Trials Online

ACT Brief: De-Identified Data Expands Trial Design, Global Production Normalizes, and FDA Updates Quality Framework

In today’s ACT Brief, we examine how large de-identified datasets are reshaping trial design and site strategy, why global ...
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 ...
Yahoo

FDA places import ban on Quality Seafood that Coast business says has no effect

The Food and Drug Administration has issued an order that bans Quality Poultry and Seafood from importing seafood, or any other food, for five years after the Biloxi business pleaded guilty last ...
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 ...
PBS

Report raises concerns about generic drug quality testing

Investigation raises concerns about lack of FDA quality testing for generic drugs By some estimates, about 90% of prescriptions in the U.S. are filled with generic drugs. The Food and Drug ...
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 ...