FDA Redactions Upheld in FOIA Suit for Drug Approval Documents
Maeve Allsup, Bloomberg Law, Oct. 6, 2020
Journalist sued for information on accelerated drug approval
High court ruling outlined requirements for confidential documents
The Food and Drug Administration correctly redacted documents regarding the approval of a drug based on a Supreme Court ruling regarding the application of the Freedom of Information Act, a federal judge in New York said Tuesday.
Charles Seife, a science writer and journalism professor sued the agency under FOIA in the U.S. District Court for the Southern District of New York, seeking records related to the accelerated approval of eteplirsen, a drug created by Sarepta Therapeutics Inc. for the treatment of a rare neuromuscular disease.
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