The Big Data Regulator, Rebooted: Why and How the FDA Can and Should Disclose Confidential Data on Prescription Drugs

Author:

Morten Christopher,Kapczynski Amy

Publisher

Elsevier BV

Reference63 articles.

1. Sunlight and Other Disinfectants: Disclosure Obligations Under the Federal Securities and Drug Regulatory Regimes, 72 FOOD & DRUG L;Joseph G Milner;J,2017

2. Availability for Public Disclosure and Submission to FDA for Public Disclosure of Certain Data and Information Related to Human Gene Therapy or Xenotransplantation;Biotechnology Industry Organization (BIO),2001

3. Lietzan has argued that prospective disclosure of safety and efficacy data by the FDA is not prohibited outright but should require compensation under the Takings Clause. See Lietzan, A New Framework, supra note 21. As we explain;Comment Letter on FDA Draft Proposals for Public Comment Regarding Disclosure Policies,2010

4. The Architecture of Government Regulation of Medical Products

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