21 C.F.R. § 601.20

Biologics licenses; issuance and conditions

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

(a) Examination—compliance with requirements. A biologics license application shall be approved only upon examination of the product and upon a determination that the product complies with the standards established in the biologics license application and the requirements prescribed in the regulations in this chapter including but not limited to the good manufacturing practice requirements set forth in parts 210, 211, 600, 606, and 820 of this chapter.

(b) Availability of product. No biologics license shall be issued unless:

(1) The product intended for introduction into interstate commerce is available for examination, and

(2) Such product is available for inspection during all phases of manufacture.

(c) Manufacturing process—impairment of assurances. No product shall be licensed if any part of the process of or relating to the manufacture of such product, in the judgment of the Director, Center for Biologics Evaluation and Research or the Director, Center for Drug Evaluation and Research, would impair the assurances of continued safety, purity, and potency as provided by the regulations contained in this chapter.

(d) Inspection—compliance with requirements. A biologics license shall be issued or a biologics license application approved only after inspection of the establishment(s) listed in the biologics license application and upon a determination that the establishment(s) complies with the standards established in the biologics license application and the requirements prescribed in applicable regulations.

(e) One biologics license to cover all locations. One biologics license shall be issued to cover all locations meeting the establishment standards identified in the approved biologics license application and each location shall be subject to inspection by FDA officials.

[64 FR 56451, Oct. 20, 1999, as amended at 70 FR 14983, Mar. 24, 2005]

Notes of Decisions

Cited in 3 cases, 1987–2015 · leading case: AG Funds, L.P. v. Sanofi, 87 F. Supp. 3d 510 (S.D.N.Y. 2015).

Sort: Relevance Newest Treatment

AG Funds, L.P. v. Sanofi, 87 F. Supp. 3d 510 (S.D.N.Y. 2015). “See 21 C.F.R. § 601.20 (d). The press release quoted Genzyme’s President and CEO, David Meeker, as stating that Lemtrada “has the potential to transform the lives of patients with Multiple Sclerosis.”

Forsyth v. Eli Lilly & Co., 904 F. Supp. 1153 (D. Haw. 1995). “The FDA’s polio vaccine regulations similarly provide that “[a] product license shall be issued only upon examination of the product and upon a determination that the product complies with the standards prescribed in the regulations.”

Berkovitz v. United States, 822 F.2d 1322 (3rd Cir. 1987). “§ 262 (d); see also 21 C.F.R. § 601.20 (a) (1987) (“[a] product license shall be issued only upon examination of the product and upon a determination that the product complies with the standards prescribed in the regulations in this subchapter”); 42 C.”

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.