Issued by: Guidance Issuing Office Office of Regulatory Affairs BACKGROUND: On occasion, questions have been raised concerning FDA’s authority over foreign origin products brought into the […]

Issued by: Guidance Issuing Office Office of Regulatory Affairs BACKGROUND: *Questions have existed among the field districts regarding the existence and extent of their authority to […]

Issued by: Guidance Issuing Office Office of Regulatory Affairs BACKGROUND: For many years, the agency has recommended the seizure not only of violative articles but also […]

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: 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 […]

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 […]

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 […]