This new pilot program is designed to accelerate the development and review of certain drugs and biological products that are aligned with U.S. national health priorities and to enhance the health interests of Americans.

Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device

CBER’s international activities can be categorized in the following functional areas: regulatory harmonization, regulatory capacity building, information sharing, international standards setting, and collaborative research.

Eligibility requirements for a regenerative medicine advanced therapy (RMAT) designation. Information on when and where to submit the request is also provided.

Jewel Osco stores in Illinois, Indiana and Iowa are voluntarily recalling select items containing tuna salad supplied by Reser’s Fine Foods. This action follows a recall initiated by Reser’s Fine Food due to…

Albertsons, Randalls and Tom Thumb stores in Arkansas, Louisiana, Oklahoma and Texas are voluntarily recalling select items containing tuna salad supplied by Reser’s Fine Foods. This action follows a recall…

This is the main page for the CBER SHINGRIX.

Are recalling Frozen ‘Deep Sprouted Mat(Moth) 16 oz. and Deep Sprouted Moong 16oz. because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal…

Development of Cancer Drugs for Use in Novel Combination – Determining the Contribution of the Individual Drugs’ Effects

KRASNIY OKTYABR INC. USA. of BROOKLYN, NY, is recalling its “ARAL SILVER VOBLA” brand “ARAL”, because the product was found to be uneviscerated.