Becker's Hospital Review

FDA finds widespread quality issues at 3 Philips sites

FDA finds widespread quality issues at three Philips medical device facilities, citing violations in manufacturing and complaint handling.
Pharmaceutical Technology on MSNOpinion

FDA inspection reveals critical supply chain vulnerabilities

Amanda Murphy, Senior Director at GlobalData, discusses how real-time intelligence can turns regulatory events into ...
Amaze Lab on MSN

FDA Issues Class II Recall of ADHD Pills After Quality Testing Failure

Sun Pharmaceutical Industries has launched a nationwide recall of ADHD medication pills after laboratory tests revealed the capsules failed to dissolve properly, raising concerns for thousands of ...
JD Supra

FDA Signals Major Shift for QMSR Transition for Medical Device Applications

Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...
American Hospital Association

FDA sends warning letter to Philips due to quality issues

The Food and Drug Administration sent a warning letter to Philips last month due to quality violations found at three of its medical device facilities earlier this year.
ScienceAlert

FDA to Remove 'Black Box' Warnings From Menopause Hormone Therapy. Here's Why.

For more than 20 years, hormone therapy for menopause has carried a warning label from the Food and Drug Administration ...
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 ...
Honolulu Star-Advertiser

FDA suspends milk quality tests amid workforce cuts

REUTERS/ANDREW KELLY/FILE PHOTO A sign is seen outside of the Food and Drug Administration headquarters in White Oak, Md., in August 2020. The FDA is suspending a quality control program for testing ...
WebMD

What to Know About the Quality of Your Medications

Recent articles have prompted questions about the quality of the nation's drug supply. Michael Kopcha, PhD, a registered pharmacist and the director of the Office of Pharmaceutical Quality at the FDA, ...
JD Supra

FDA Moves to Streamline Biosimilar Development: Implications for Regulatory Strategy and Clinical Study Design

The Food and Drug Administration (FDA) has issued new draft guidance signaling a policy shift toward reducing the need for comparative efficacy ...
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 ...
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 ...