C.F.R. » Title 21 » 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 › Subpart D—FDA Action on Applications and Abbreviated Applications

21 C.F.R. § 314.100

Timeframes for reviewing applications and abbreviated applications

Read at: eCFRecfr.gov CornellLII GovInfogovinfo.gov CasesGoogle Scholar

(a) Except as provided in paragraph (c) of this section, within 180 days of receipt of an application for a new drug under section 505(b) of the act or an abbreviated application for a new drug under section 505(j) of the act, FDA will review it and send the applicant either an approval letter under § 314.105 or a complete response letter under § 314.110. This 180-day period is called the “initial review cycle.”

(b) At any time before approval, an applicant may withdraw an application under § 314.65 or an abbreviated application under § 314.99 and later submit it again for consideration.

(c) The initial review cycle may be adjusted by mutual agreement between FDA and an applicant or as provided in §§ 314.60 and 314.96, as the result of a major amendment.

[73 FR 39609, July 10, 2008]
Notes of Decisions
Cited in 8 cases, 1979–2020 · leading case: Parke, Davis & Co. v. Joseph A. Califano, Sec'y of Health, Educ. & Welfare, 623 F.2d 1 (6th Cir. 1980).
Sort: Relevance Newest Treatment
Parke, Davis & Co. v. Joseph A. Califano, Sec'y of Health, Educ. & Welfare, 623 F.2d 1 (6th Cir. 1980). “21 C.F.R. §§ 314.100 et seq. In addition to requiring approval if none of the grounds specified in 21 U.”
Tummino v. Torti, 603 F. Supp. 2d 519 (E.D.N.Y 2009). “§ 355 (c); 21 C.F.R. § 314.100 (a). Moreover, during this seven month period— during which time no FDA staff appear to have worked on the Plan B matter — neither Acting Deputy Commissioner Woodcock nor Acting CDER Director Galson knew what Acting Commissioner Crawford was doing…”
TorPharm, Inc. v. Thompson, 260 F. Supp. 2d 69 (D.D.C. 2003). “20 (e) (general rule for FDA docket submissions); 21 C.F.R. § 314.100 (a) (timeframes for reviewing NDAs and ANDAs); 314 C.”
Bristol-Myers Squibb Co. v. Copley Pharm., Inc., 144 F. Supp. 2d 21 (D. Mass. 2000). “§ 355 (j)(5)(A); 21 C.F.R. § 314.100 . Copley may receive tentative approval of the ANDA, with only final approval delayed by the litigation.”
Norwich Eaton Pharm., Inc. v. Bowen, 808 F.2d 486 (6th Cir. 1987). · cites it 2× “The District Court thus concluded that the FDA’s letter of December 29, 1981 merely indicated Buprenex’s “approvable” status under 21 C.F.R. § 314.100 (d) 3 and that “the FDA’s ‘approval’ of the Buprenex NDA was contingent upon and not effective until approval of labeling in its…”
Pharm. Mfrs. Ass'n v. Kennedy, 471 F. Supp. 1224 (D. Maryland 1979). “Omission of a drug product from the list would not necessarily mean that the drug product is in violation of section 505 and 507 of the act, or that it is not safe or effective, or that it may not be therapeutically equivalent to other drug products. Decisions on whether…”
Norwich Eaton Pharm., Inc. v. Bowen, 645 F. Supp. 321 (S.D. Ohio 1986). “Finkel was notice of the “approvable” status of Buprenex in accordance with the FDA’s ordinary practice under 21 C.F.R. § 314.100 (d). It is equally clear that Dr.”
Tomaszewski v. Trevena, Inc. (E.D. Pa. 2020). “81 Because conclusory allegations do not satisfy the PSLRA’s heightened standards, Plaintiffs’ cannot maintain a claim based on Soergel’s July 20, 2017 statement.”
Annotations are extracted automatically from the opinions in the Syfert caselaw corpus and ranked by authority, recency, and treatment. Dots show Syfertize treatment of the citing case itself.