In a new draft guidance, issued on October 29, 2025, the FDA proposed major updates to simplify biosimilarity studies and potentially reduce ...

The Food and Drug Administration (FDA) has issued new draft guidance signaling a policy shift toward reducing the need for comparative efficacy ...

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

The draft guidance, which is touted as a way to reduce the cost and time-associated burden of biosimilar development, has been met with mixed industry reaction.

The FDA is removing the black box warning on estrogen therapy after two decades. Should it?Women who want to use estrogen to ...

Recognizing the increased use of artificial intelligence in the development of new therapies, the U.S. FDA on Monday released separate draft guidance on the use of the technology in the development of ...

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

At long last, the Food and Drug Administration will remove a “black box warning” label required on the packaging of most ...

The Federal Trade Commission submitted a comment supporting the Food and Drug Administration’s draft guidance regarding interchangeable biosimilar drugs that can be substituted for brand-name biologic ...

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