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 ...
The Baltimore Sun

FDA announces sweeping changes to speed up the drug review process

The Food and Drug Administration has announced some major changes to the review process for drug developers in the United States. It could cut down the time from 10 to 12 months for a review to just ...
Axios on MSN

FDA chief's bid to speed drug reviews hits turbulence

Food and Drug Administration commissioner Marty Makary's flagship effort to overhaul how the agency reviews drugs is facing ...
Just The News

FDA hasn't fully complied with 2011 food safety law, modern food tracking system not ready: GAO

FDA officials told GAO that competing priorities and an agency reorganization in late 2024 have slowed progress, estimating ...
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 ...
CIDRAP

FDA needs sharper focus on foodborne-illness prevention, accountability office says

A Government Accountability Office (GAO) report released yesterday finds that while the US Food and Drug Administration (FDA) ...