Zdrowie i gospodarka · 03/04/2012

FDA Releases Draft Guidance on Drug Sample Reporting Compliance Policy Under Affordable Care Act

The Food and Drug Administration (FDA) has released a draft guidance for the pharmaceutical industry regarding the reporting of drug sample distribution information under the Affordable Care Act. The guidance outlines the FDA's approach to implementing the transparency provisions, stating that it will not object to non-compliance until October 1, 2012, unless manufacturers and distributors submit required information.