FDA commissioner Scott Gottlieb says the agency is working on about a dozen new policies to help the fledgling biosimilar market grow and gain accepta...
FDA says a proposed USP monograph on biological products should be withdrawn because it could impede or delay licensure of biosimilars.
FDA publishes statistics relating to drug and medical device facility inspections required under the FDA Reauthorization Act.
Federal Register notice: FDA submits for OMB approval an information collection extension for Premarket Notification for a New Dietary Ingredient 21 ...
A federal judge approves a consent decree of permanent injunction sought by FDA against dietary supplement distributor MyNicNaxs and two of its execut...
CDRH Office of Device Evaluation policy analyst James Bertram tells a Webinar audience that changes under the Cures Act require sponsors to self-ident...
Federal Register Final Rule; technical amendment: FDA amends its regulations to reflect an organizational change for CDERs Office of Regulatory Policy...
FDA releases its latest batch of Warning Letters that includes Biotek Inc., Clover Custom Blending and Keshava Organics.