Zdrowie i gospodarka · 03/04/2012

Draft Guidance for Industry on Compliance Policy for Reporting Drug Sample Distribution Information; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Compliance Policy on Reporting Drug Sample Distribution Information Under the Affordable Care Act." This draft guidance is intended to provide information regarding the Agency's implementation of the drug sample transparency reporting provisions of section 6004 of the Patient Protection and Affordable Care Act. The draft guidance notifies entities covered by the reporting obligations in section 6004 that FDA does not intend to object until at least October 1, 2012, if manufacturers and authorized distributors of record (ADRs) do not submit information under those reporting provisions and that the Agency intends to provide notice before revising its exercise of discretion with respect to compliance.