Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 – Specific Electronic Submissions Intended For FDA’s Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed […]

Issued by: Guidance Issuing Office Office of Regulatory Affairs Compliance Policy Guide Sec. 230.120- Human Blood and Blood Products As Drugs is obsolete and was withdrawn […]

Issued by: Guidance Issuing Office Office of Regulatory Affairs BACKGROUND: A district compliance officer has inquired if a domestic distributor can take advantage of the immunity […]

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 […]