Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...

The FDA plans to eliminate comparative clinical study requirements that currently add $24 million and up to eight years to ...

In June 2025, the US Food and Drug Administration (FDA) issued a final guidance titled Cybersecurity in Medical Devices: Quality System ...

The bill prohibited the FDA from enforcing regulations aimed at increasing traceability of the supply chain, among other ...

FDA Section 524B transformed medical device cybersecurity from guidance to law, challenging small medtech firms with ...

The “plausible mechanism” pathway, outlined by Martin Makary and Vinay Prasad, is designed to help accelerate treatments ...

The Food and Drug Administration (FDA) on Thursday called for new regulations for the cannabidiol (CBD) market, saying the agency needs to provide additional oversight to manage the risks involved in ...

Please provide your email address to receive an email when new articles are posted on . The FDA plans to reduce and potentially replace animal testing for developing monoclonal antibody therapies and ...

WASHINGTON (AP) — The Food and Drug Administration is reconsidering whether doctors who prescribe painkillers like OxyContin should be required to take safety training courses, according to federal ...

The “plausible mechanism pathway” will allow personalised drugs to reach the market sooner for patients with genetic diseases ...

In a policy shift unveiled by the Trump Administration on Monday, top officials for the Food and Drug Administration (FDA) said they will no longer routinely approve the COVID booster for healthy ...

The U.S. Food and Drug Administration finalized recommendations Thursday to loosen its blood-giving guidelines by now using risk-based questions rather than time-based questions to determine if ...