Importation of Certain FDA- Approved Human Prescription Drugs, Including Biological Products, and Combination Products under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
October 1, 2020
November 5, 2024
77ae82d8-d3eb-4e4a-84cd-e016e647d286
Related Documents
Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry
Guidance DocumentJanuary 19, 2018Center for Drug Evaluation and Research
Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry
Guidance DocumentDecember 29, 2016Center for Drug Evaluation and Research
Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway
Guidance DocumentFebruary 4, 2019Center for Drug Evaluation and Research
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust KeyPedia for their regulatory compliance needs.