Issued by: Guidance Issuing Office Office of Regulatory Affairs BACKGROUND: 19 CFR 18.21(b) states: “Narcotics and other articles prohibited admission into commerce of the United States […]

Issued by: Guidance Issuing Office Office of Regulatory Affairs BACKGROUND: Potential criminal cases are frequently preceded by an opportunity for proposed defendants to present their views […]

Issued by: Guidance Issuing Office Office of Regulatory Affairs BACKGROUND: Section 305 of the Act states: “Before any violation of this Act is reported by the […]

Issued by: Guidance Issuing Office Office of Regulatory Affairs BACKGROUND: FDA occasionally receives requests for microbiological cultures isolated from samples analyzed by FDA. Requests for other […]

Strother D. Dixon, a senior regulatory project manager in OND’s Division of Dermatology and Dentistry, received a breast cancer diagnosis on Friday, March 13, 2009. Even […]

Image Anthim (obiltoxaximab) injection, for intravenous use Anthrasil [Anthrax Immune Globulin Intravenous (Human)], sterile solution for infusion (CBER) Biothrax (Anthrax Vaccine Adsorbed) (CBER) Ciprofloxacin Cyfendus (FDA […]

FDA Recognizes Rare Disease Day On February 28, 2019, FDA joins the global observance of Rare Disease Day, which was created to raise awareness about the […]

On This Page Date: November 7, 2024 Time: 1:00 PM – 2:30 PM ET Visit CDER Small Business and Industry Assistance Page ABOUT THIS EVENT (Hosted […]

On This Page Date: December 4, 2024 Time: 1:00 PM – 3:00 PM ET Visit CDER Small Business and Industry Assistance Page ABOUT THIS EVENT (Hosted […]