The US Food and Drug Administration (FDA) on Monday finalized guidance to assist sponsors in their meeting requests with the agency for products subject to product-specific guidance (PSG). The final ...
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The Food and Drug Administration’s (FDA) advisory committee on vaccines this week will consider whether to change the ...
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FDA to weigh easing limits on unproven peptides favored by RFK Jr. and other MAHA figures
Federal health officials will meet in July to weigh easing limits on a group of drugs popular with Robert F. Kennedy Jr.'s Make America Healthy Again movement.
The US Food and Drug Administration (FDA) published a revised draft guidance this week meant to help drugmakers developing biosimilars navigate when and how to convene meetings with the agency. The 20 ...
On March 27, 2026, the Food and Drug Administration (“FDA”) held a public meeting entitled “Exploring the Scope of Dietary Supplement Ingredients.” Sponsored by FDA’s Office of Dietary Supplement ...
At a September 30, 2025, public meeting hosted by the U.S. Food and Drug Administration (FDA), industry stakeholders expressed strong support for the newly launched FDA PreCheck Program, while raising ...
FDA stated that the “proposed data may be capable of supporting the submission and review of an [NDA] under the accelerated approval pathway” for ...
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