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After a short delay and concerns of potential intervention from senior officials, the FDA has issued a draft guidance for the industry on the potential use of minimal residual disease (MRD) and ...

The FDA released a draft guidance document that provides a regulatory framework for sponsors to utilize minimal residual ...

On January 6, 2026, the US Food and Drug Administration (FDA) issued two revised guidance documents relating to general ...

On Jan. 6, 2026, the U.S. Food and Drug Administration (FDA) updated the final guidance documents General Wellness: Policy ...

The company also stands to gain from recent regulatory FDA guidance aimed at streamlining the development of non-opioid ...

An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...

For companies developing interchangeable biosimilars, the FDA guidance opens the door to more tailored, risk-based programs that may reduce reliance on costly comparative efficacy studies (CES). For ...

The FDA’s new draft guidance on Bayesian methodology signals a shift toward more flexible, data-driven clinical trial designs, enabling sponsors to use prior data and adaptive approaches to improve ...

FDA Commissioner Marty Makary called these changes “common-sense reforms” that could expedite the development of cell and ...

The FDA issued draft guidance Jan. 21 proposing the use of minimal residual disease and complete response as primary endpoints to support accelerated approval of drugs for multiple myeloma. The draft ...

M4Q (R2) is a globally harmonized framework for structuring quality information in medicinal product registration ...