FDA will drop two-study requirement for new drug approvals, aiming to speed access

WASHINGTON (AP) — The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies to ...

Moderna Announces the U.S. Food and Drug Administration will Initiate the Review of Its Investigational Seasonal Influenza Vaccine Submission

Following a Type A meeting, the FDA's Center for Biologics Evaluation and Research has notified Moderna that its biologics ...

FDA chief Marty Makary says 'everything should be over the counter' unless drug is unsafe or addictive

Makary said the FDA is looking at prescription drugs like nausea medications and vaginal estrogen, and hopes to make changes this year.

FDA recalls certain oysters shipped to Florida for possible norovirus contamination

The FDA is advising restaurants and retailers to not serve or sell certain raw oysters due to a possible norovirus contamination.

FDA will drop two-study requirement for new drug approvals

WASHINGTON — The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies to win ...

FDA chief warns US is losing ground to China in early drug development, calls for faster trial approvals

Makary pointed to three bottlenecks: hospital contracting; ethical reviews and approvals; and the Investigational New Drug ...

FDA Grants Breakthrough Device Designation to Two Rapid Tests Targeting Critical Drug-Resistant Pathogens

NG Biotech, in partnership with Hardy Diagnostics, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designations to two rapid diagnostic assays: ...
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Spruce Biosciences reports positive FDA meetings as it prepares TA-ERT filing for rare pediatric disorder

Spruce Biosciences, Inc. (NASDAQ:SPRB) said it has completed two Type B meetings with the U.S. Food and Drug Administration (FDA), clearing key regulatory discussions ahead of its planned biologics ...