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Drug Sample Reporting Must Be Streamlined, PhRMA Tells FDA

 
• By Martin Berman-Gorvine

FDA could be flooded with “millions of duplicative signatures” every time a health care practitioner requests a drug sample, the trade group warns.

The Pharmaceutical Research and Manufacturers of America is trying to ease the potential burden on industry of FDA’s draft guidance on reporting drug sample distribution by focusing on the responsibility of manufacturers and distributors vis-à-vis health care practitioners’ signatures and aggregation of multiple sample distribution reports under a single practitioner’s signature.

The organization also is seeking more time for industry to implement the new requirements, which were enacted along with the Affordable Care Act. The law gave a deadline of April...

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