21 U.S.C. § 1 to 5 June 25, 1938, ch. 675, §1002(a), formerly §902(a), 52 Stat. 1059; renumbered §1002(a), Pub. L. 111-31, div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784 Section 1, act June 30, 1906ch. 3915, §1June 30, 1906, 34 Stat. 768, made it unlawful to manufacture adulterated or misbranded foods or drugs in Territories or District of Columbia and provided penalty for violations. See sections 331 and 333 of this title. Section 2, act June 30, 1906ch. 3915, §2June 30, 1906, 34 Stat
(a) Definitions As used in this section, the term "pediatric studies" or "studies" means at least one clinical investigation (that, at the Secretary's discretion, may include pharmacokinetic studies) in pediatric age groups (including neonates in appropriate cases) in which a drug is anticipated to be used, and, at the discretion of the Secretary, may include preclinical studies. (b) Market exclusivity for new drugs (1) In general Except as provided in paragraph (2), if, prior to approval of an application
(a) In general The Secretary shall establish a program to evaluate the potential use of real world evidence- (1) to help to support the approval of a new indication for a drug approved under section 355(c) of this title; and (2) to help to support or satisfy postapproval study requirements. (b) Real world evidence defined In this section, the term "real world evidence" means data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than traditional clinical
(a)Issues to be briefed and argued (1) On or after ordering review, the Supreme Court may specify the issues to be briefed and argued. Unless the court orders otherwise, the parties must limit their briefs and arguments to those issues and any issues fairly included in them. (2) Notwithstanding an order specifying issues under (1), the court may, on reasonable notice, order oral argument on fewer or additional issues or on the entire cause. (b)Issues to be decided (1) The Supreme Court may decide
(a)In general Except as provided in this rule, a petition for review, answer, and reply must comply with the relevant provisions of rule 8.204. (Subd (a) amended effective January 1, 2007.) (b) Contents of a petition (1) The body of the petition must begin with a concise, nonargumentative statement of the issues presented for review, framing them in terms of the facts of the case but without unnecessary detail. (2) The petition must explain how the case presents a ground for review under rule 8.500(b)
(a)Proof of service When a statute or this rule requires a party to serve any document on a nonparty public officer or agency, the party must file proof of such service with the document unless a statute permits service after the document is filed, in which case the proof of service must be filed immediately after the document is served on the public officer or agency. (Subd (a) relettered effective January 1, 2007; adopted as subd (b).) (b)Identification on cover When a statute or this rule requires