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Drug Sample Reporting: FDA Doesn’t Want Signatures, But Firms Need Them On File

 
• By Sue Sutter

Revisions to draft guidance implementing Affordable Care Act streamline some requirements – allowing sponsors, authorized distributors, or even third parties to submit reports to FDA.

Pharmaceutical manufacturers and their authorized distributors need not submit actual signatures of health care providers that request and receive drug samples but, instead, must affirm that they have such signatures on file to satisfy reporting provisions under the Affordable Care Act, FDA said in a new guidance.

The draft guidance spells out FDA’s expectations for the types of information manufacturers and authorized distributors of record (ADR) should submit through the agency’s Electronic Submissions Gateway to...

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More from North America

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