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FDA Releases Draft Guidance for Industry Regarding Medication Guides
Food and Drug Administration (FDA) has released a draft guidance that addresses two topics pertaining to medication guides for drug and biological products – the agency’s enforcement discretion regarding the distribution of medication guides to health care providers and REMS requirements. Comments on the document, “Guidance for Industry: Medication Guides – Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS)” (PDF) should be submitted within 90 days of the publication date (February 28, 2011) and according to the instructions provided in the Federal Register notice. The notice can be accessed using the Federal Register Web site advanced search feature by entering the notice date and the search term “page 10908-10909”.
