(a) A biologics license shall be issued upon a determination by the Director, Center for Biologics Evaluation and Research or the Director, Center for Drug Evaluation and Research that the establishment(s) and the product meet the applicable requirements established in this chapter. A biologics license shall be valid until suspended or revoked.
(b) If the Commissioner determines that the establishment or product does not meet the requirements established in this chapter, the biologics license application shall be denied and the applicant shall be informed of the grounds for, and of an opportunity for a hearing on, the decision. If the applicant so requests, the Commissioner shall issue a notice of opportunity for hearing on the matter pursuant to § 12.21(b) of this chapter.
[42 FR 4718, Jan. 25, 1977, as amended at 42 FR 15676, Mar. 22, 1977; 42 FR 19142, Apr. 12, 1977; 64 FR 56450, Oct. 20, 1999; 70 FR 14983, Mar. 24, 2005]
Notes of Decisions
Berkovitz v. United States, 486 U.S. 531 (1988).
· cites it 2× “1964); see 21 CFR § 601.4 (1987). In addition, a regulation states that “[a]n application for license shall not be considered as filed” until the DBS receives the information and data regarding the product that the manufacturer is required to submit.”
United States v. Kisala, 64 M.J. 50 (C.A.A.F. 2006).
· cites it 2× “See Press Release, FDA Issues Final Rule and Final Order Regarding Safety and Efficacy of Certain Licensed Biological Products Including Anthrax Vaccine (Dec.”
CareToLive v. Von Eschenbach, 525 F. Supp. 2d 938 (S.D. Ohio 2007).
“Further, under certain circumstances the FDA will approve a BLA, 21 C.F.R. § 601.4 (a), or deny it and proAdde the applicant the opportunity for a hearing, id.”
Caretolive v. Von Eschenbach, 525 F. Supp. 2d 952 (S.D. Ohio 2007).
“Under certain circumstances, the FDA will approve a BLA, 21 C.F.R. § 601.4 (a), or deny it and provide the applicant the opportunity for a hearing, id.”
Lane v. United States, 918 F. Supp. 864 (E.D. Pa. 1996).
“1964); 21 CFR § 601.4 (1987). Another regulation stated that an application for a license “shall not be considered as filed” until the National Institutes of Health’s Division of Biological Standards receives the data regarding the product that the manufacturer is required to…”
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