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

Revisions to draft guidance implementing Affordable Care Act streamline some requirements – allowing sponsors, authorized distributors, or even third parties to submit reports to FDA.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

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from United States

More from North America