Source: https://www.ecfr.gov/cgi-bin/text-idx?mc=true&node=sp21.5.314.h&rgn=div6
Timestamp: 2020-07-09 15:31:24
Document Index: 187453960

Matched Legal Cases: ['art 314', '§314', '§314', '§314', '§314', '§314', '§314', '§314', '§314', 'art 15', '§314', '§314', '§12', '§10', '§10', '§314', '§314', '§314', '§314', '§314', '§314', '§10']

Title 21 → Chapter I → Subchapter D → Part 314 → Subpart H
Subpart H—Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses
§314.500 Scope.
§314.510 Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity.
§314.520 Approval with restrictions to assure safe use.
§314.530 Withdrawal procedures.
§314.540 Postmarketing safety reporting.
§314.550 Promotional materials.
§314.560 Termination of requirements.
Source: 57 FR 58958, Dec. 11, 1992, unless otherwise noted.
(a) For new drugs approved under §§314.510 and 314.520, FDA may withdraw approval, following a hearing as provided in part 15 of this chapter, as modified by this section, if:
(b) Notice of opportunity for a hearing. The Director of the Center for Drug Evaluation and Research will give the applicant notice of an opportunity for a hearing on the Center's proposal to withdraw the approval of an application approved under §314.510 or §314.520. The notice, which will ordinarily be a letter, will state generally the reasons for the action and the proposed grounds for the order.
(2) If the applicant files a timely request for a hearing, the agency will publish a notice of hearing in the Federal Register in accordance with §§12.32(e) and 15.20 of this chapter.
(d) Separation of functions. Separation of functions (as specified in §10.55 of this chapter) will not apply at any point in withdrawal proceedings under this section.
(f) Judicial review. The Commissioner's decision constitutes final agency action from which the applicant may petition for judicial review. Before requesting an order from a court for a stay of action pending review, an applicant must first submit a petition for a stay of action under §10.35 of this chapter.
Drug products approved under this program are subject to the postmarketing recordkeeping and safety reporting applicable to all approved drug products, as provided in §§314.80 and 314.81.
If FDA determines after approval that the requirements established in §314.520, §314.530, or §314.550 are no longer necessary for the safe and effective use of a drug product, it will so notify the applicant. Ordinarily, for drug products approved under §314.510, these requirements will no longer apply when FDA determines that the required postmarketing study verifies and describes the drug product's clinical benefit and the drug product would be appropriate for approval under traditional procedures. For drug products approved under §314.520, the restrictions would no longer apply when FDA determines that safe use of the drug product can be assured through appropriate labeling. FDA also retains the discretion to remove specific postapproval requirements upon review of a petition submitted by the sponsor in accordance with §10.30.