Experts say two new guidances — issued without the usual public comment period — leave questions about how patients will navigate a growing pool of wearables.
For companies developing digital health products, wearables, or software-enabled devices, FDA’s latest guidance updates ...
The FDA has approved a label update for an inhaled insulin indicated for adults with type 1 or type 2 diabetes, according to ...
The FDA released a draft guidance document that provides a regulatory framework for sponsors to utilize minimal residual ...
On Jan. 6, 2026, the U.S. Food and Drug Administration (FDA) updated the final guidance documents General Wellness: Policy ...
The post The FDA's Hands-Off Approach to Medical AI Is a Win for Health-Conscious Consumers appeared first on Reason.com.
After a short delay and concerns of potential intervention from senior officials, the FDA has issued a draft guidance for the industry on the potential use of minimal residual disease (MRD) and ...
PharmaEssentia Announces Updated NCCN Clinical Practice Guidelines Include ropeginterferon alfa-2b-njft (BESREMi®) for ...
On January 6, 2026, the US Food and Drug Administration (FDA) issued two revised guidance documents relating to general ...
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 ...
WASHINGTON, D.C., USA — The U.S. Food and Drug Administration on Wednesday released 10 new guidelines for drug manufacturers to follow when using artificial intelligence to develop new treatments. The ...
The company also stands to gain from recent regulatory FDA guidance aimed at streamlining the development of non-opioid ...
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