BioSpace

AbbVie, Amgen, Lilly Lead Calls for FDA To Update Post-Approval Change Rules

Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the ...

Alpha Tau Submits First Pre-Market Approval Module to the FDA for Alpha DaRT® for the Treatment of Recurrent Cutaneous Squamous Cell Carcinoma (cSCC)

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

The FDA Development and Approval Process for Medications and Medical Devices

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
Medical News Today

What does FDA approval mean? A guide to understand the process

FDA approval describes when the Food and Drug Administration (FDA) deems a medical product safe and effective for its intended use based on scientific data and testing. Before people use a medical ...

Exclusive: US FDA delays two drug reviews in new voucher program after safety, efficacy concerns

The U.S. Food and Drug Administration has delayed reviews of two drugs chosen for the Trump administration's new fast-track program after agency scientists flagged safety and efficacy concerns, ...