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Revisions to draft guidance implementing Affordable Care Act streamline some requirements – allowing sponsors, authorized distributors, or even third parties to submit reports to FDA.
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Drug Sample Reporting Must Be Streamlined, PhRMA Tells FDA
FDA could be flooded with “millions of duplicative signatures” every time a health care practitioner requests a drug sample, the trade group warns.
Drug Sample Distribution Reporting Deadline Extended By FDA
FDA is giving manufacturers six more months to provide HHS with information on the distribution of drug samples as it plans further guidance; the Affordable Care Act mandated that the data be submitted by April 1.
Diabetes Drugs: US FDA Proposes Hypoglycemia Efficacy Endpoints, With Limits
Reduction in the risk of hypoglycemia level 2 and 3 events, along with either a reduction or maintenance of an acceptable hemoglobin A1C, is a clinically relevant efficacy endpoint for drug development in Types 1 and 2 diabetes, FDA states in new draft guidance.