View the PDF for 21 CFR Part 314; These links go to the official, published CFR, which is updated annually. As a result, it may not include the most recent changes applied to the CFR. Learn more.

2024年12月24日 · For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Note: If you need help accessing information in different file …

View the PDF for 21 CFR Part 314 Subpart H; These links go to the official, published CFR, which is updated annually. As a result, it may not include the most recent changes applied to the …

Electronic Code of Federal Regulations (e-CFR) Title 21—Food and Drugs; CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES; …

Pt. 314 21 CFR Ch. I (4–1–20 Edition) PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Subpart A—General Provisions Sec. 314.1 Scope of this part. 314.2 …

2024年12月24日 · For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Note: If you need help accessing information in different file …

PART 314 - APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG . Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 355a, 355f, 356, 356a, 356b, 356c, 356e, 360cc, 371, …

View the PDF for 21 CFR Part 314; These links go to the official, published CFR, which is updated annually. As a result, it may not include the most recent changes applied to the CFR. Learn more.

2024年6月18日 · (a) This part sets forth procedures and requirements for the submission to, and the review by, the Food and Drug Administration of applications and abbreviated applications …

2022年2月22日 · The free checklist includes all of the regulations in 21 CFR Part 314 that new drug applicants must be aware of and follow. By following the checklist and marking off items …