Section 314.93 - Petition to request a change from a listed drug
1 Citing brief
Association of American Physicians and Surgeons, Inc. et al v. Food and Drug Administration et al
REPLY to opposition to motion re MOTION to Alter Judgment MOTION for Judgment on Partial Findings MOTION for Leave to File Second Amended Complaint MOTION for Reconsideration re Order on Motion to Dismiss, 42 Memorandum & Opinion MOTION for Reconsideration re Order on Motion to Dismiss, 42 Memorandum & Opinion MOTION for Reconsideration re Order on Motion to Dismiss, 42 Memorandum & Opinion
Filed April 11, 2008
The Center for Drug Evaluation and Research (CDER) is responsible for responding to citizen petitions relating to certain drug products, including generic drugs. Within CDER, the Office of Regulatory Policy (ORP) has primary responsibility for drafting responses to citizen petitions, except for petitions relating to over- the-counter drug monographs or ``suitability'' petitions (see 21 CFR 314.93). Recently, CDER has seen a significant increase in petitions.