Issued by: Guidance Issuing Office Office of Regulatory Affairs BACKGROUND: The Food and Drug Administration has used income tax information from the Internal Revenue Service in […]

Issued by: Guidance Issuing Office Office of Regulatory Affairs BACKGROUND: The agency has received many questions concerning the use of microfiche and/or microfilm systems in lieu […]

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: 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 […]