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Milestone:
Best Pharmaceuticals for Children Act
Download PDF - 76KB]

Status:
U.S. Law

Description:
Provides six-month patent extension for manufacturers who conduct voluntary pediatric trials.

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Milestone:
FDA has prepared this guidance in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act. It is intended to help small businesses better understand the new informed consent requirements set forth in 21 CFR § 50.25(c).
View Guidance for Sponsors, Investigators, and Institutional Review Boards

Status:
FDA rule

Description:
For applicable clinical trials initiated on or after March 7, 2012, informed consent documents must be in compliance with the new requirement in 21 CFR § 50.25(c) and include a specific statement that refers to the trial’s description on www.ClinicalTrials.gov.

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