(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 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)