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Revisions to draft guidance implementing Affordable Care Act streamline some requirements – allowing sponsors, authorized distributors, or even third parties to submit reports to FDA.
You may also be interested in...
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.
Lengthy withdrawal process creates an opening for the FDA to better convey its concerns about a medicine’s benefit-risk profile in a way that impacts prescribing guidelines, Johns Hopkins’ Joshua Sharfstein says; CDER’s Jacqueline Corrigan-Curay says new expedited withdrawal procedures under omnibus law appear more ‘streamlined’ than those followed for Makena.