Generic Firms Likely To Withdraw Drugs If US FDA’s Pursues ‘Disastrous’ PANDA Policy
Teva says it is evaluating the potential market withdrawal of many products approved prior to enactment of the Hatch-Waxman Act in response to an FDA proposal to treat them as new drug applications. AAM notes that many of these so-called PANDA drugs are on the agency’s drug shortage list.
You may also be interested in...
The agency aims to treat ANDAs approved prior to enactment of the Hatch-Waxman amendments, dubbed PANDAs, as 505(b) NDAs. The goal is to make it easier to designate products as reference listed drugs, but experts say it effectively turns ANDA holders into NDA holders, which could have implications for label changes, patent listings, and product liability litigation.
FDA guidances have provided ‘major step forward’ for use of social media data, Roche researcher notes. Agency staffer offers checklist for collecting patient experience data in this realm.
Agency staff note hurdles in obtaining evidence outlined in FDA’s patient-focused drug development guidance to support regulatory decision-making.