eCFR :: 21 CFR Part 314 -- Applications for FDA Approval to …
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.
CFR - Code of Federal Regulations Title 21 - Food and Drug Administration
Dec 24, 2024 · 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 formats, see...
eCFR :: 21 CFR 314.106 -- Foreign data.
View Title 21 on govinfo.gov; View the PDF for 21 CFR 314.106; 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.
Per 21 CFR 314.94(a)(9)(iii), a variation between test and RLD products is allowed for parenteral formulations with respect to buffer, preservative, and antioxidant provided that the applicant...
21 CFR Part 314 - LII / Legal Information Institute
Electronic Code of Federal Regulations (e-CFR) Title 21—Food and Drugs; CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES; SUBCHAPTER D—DRUGS FOR HUMAN USE; PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
21 CFR 314 - eCFR - Electronic Code of Federal Regulations e-CFR
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, 374, 379e, 379k-1. Source: 50 FR 7493, Feb. 22, 1985, unless otherwise noted.
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 Purpose. 314.3 Definitions. Subpart B—Applications 314.50 Content and format of an NDA. 314.52 Notice of certification of invalidity, unenforceability, or noninfringement of
eCFR :: 21 CFR Part 314 -- Applications for FDA Approval to …
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.
Regulations: Good Clinical Practice and Clinical Trials | FDA
Jan 21, 2021 · Premarket Approval of Medical Devices (21 CFR Part 814) Preambles to GCP Regulations Each time Congress enacts a law affecting products regulated by the Food and Drug Administration, the FDA...
21 CFR 314.101 -- Filing an NDA and receiving an ANDA.
§ 314.101 Filing an NDA and receiving an ANDA. (a) Filing an NDA. (1) Within 60 days after FDA receives an NDA, the Agency will determine whether the NDA may be filed. The filing of an NDA means that FDA has made a threshold determination that the NDA is sufficiently complete to permit a substantive review.