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

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

Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...

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.

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 ...

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 ...

The Food and Drug Administration (FDA) has issued new draft guidance signaling a policy shift toward reducing the need for comparative efficacy ...

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 ...

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, ...

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 ...

WASHINGTON (Reuters) -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 ...

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 ...