Reference #: 3028008119 Product: CosmeticsDrugs Issuing Office: Center for Drug Evaluation and Research | CDER United States Secondary Issuing Offices United States WARNING LETTER March 25, […]

Reference #: 3028005436 Product: CosmeticsDrugs Recipient: Recipient Name Skylor Eli Burbank Sky Bank Media, LLC dba Painless Tattoo Cream Co. 1208 W Margaret Rose DriveRiverton, UT […]

Submit Comments by 06/27/2024 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]

How to engage with the Biomarker Qualification Program (BQP) If you have pre-submission or general inquiry questions or you want to make a meeting request, please […]

Spotlights Events & Announcements To locate a project or a qualified biomarker go to CDER & CBER’s DDT Qualification Project Search database Web content is updated […]

On this page: As defined by FDA, real-world data (RWD) are the data relating to patient health status and/or the delivery of health care routinely collected […]

Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Product: Drugs Recipient: Recipient Name Bret R. Rutherford, M.D. Bret R. Rutherford, M.D. New York State Psychiatric […]

Under section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), at least 24 months after the issuance of a final guidance document in […]

Reference #: FEI 3006441852 Product: Drugs Recipient: Recipient Name Nathan Trembath Recipient Title General Manager Abraxis Bioscience LLC 620 N 51 St. Ave.Phoenix, AZ 85043United States […]