Initial module submission marks an important milestone in the pre-market approval process - - Flexible modular submission ...

Americans rely on the Food and Drug Administration to make sure that medical devices are safe. Reporting by KFF Health News has raised questions about how the FDA has dealt with some products, ...

A senior Food and Drug Administration official on Friday said the agency will change its vaccine approval process, alleging that COVID-19 vaccination resulted in the deaths of 10 children.Video above: ...

A complete response letter is a formal communication from the FDA indicating that an application cannot be approved in its present form. In the case of Outlook Therapeutics, the FDA noted that while ...

Many physicians are unfamiliar with how the Food and Drug Administration’s (FDA) regulates new drugs and medical devices, and they may be under the impression that the data supporting these approvals ...

The Food and Drug Administration is seeking comments on how to handle approval of animal food ingredients following last week’s announcement it will not be renewing a memorandum of understanding with ...

ADMA Biologics receives FDA approval for a process enhancing plasma production yields by 20%, boosting growth and capacity for its products. ADMA Biologics, Inc. has announced the U.S. FDA approval of ...

ScinoPharm Taiwan (TWSE: 1789) today announced a landmark achievement in the global pharmaceutical landscape, securing U.S. Food and Drug Administration (FDA) approval for Glatiramer Acetate Injection ...

The FDA’s decision shines a light on some of the unique obstacles that psychedelic drugs may face on the path to approval. The pharma industry claims lower prescription drug prices will mean less ...