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Revisions to draft guidance implementing Affordable Care Act streamline some requirements – allowing sponsors, authorized distributors, or even third parties to submit reports to FDA.
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FDA could be flooded with “millions of duplicative signatures” every time a health care practitioner requests a drug sample, the trade group warns.
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.
However, David Kaslow, director of the FDA’s vaccines office, says only a ‘may’ recommendation is supported and that giving an extra dose after June ‘may not be optimal’ if vaccines are reformulated for the fall.