FDA says its lab findings again link Rugby Dioctos oral liquid docusate sodium to Burkholderia cepacia.
FDA Review posts the Federal Register notices for the week ending 10/27/2017.
Federal Register notice: FDA seeks comments on an information collection extension about a guidance on dispute resolution procedures for CVM regulator...
FDA releases a draft guidance on Assessing User Fees Under the Generic Drug User Fee Amendments of 2017.
Federal Register notice: FDA makes available a draft guidance entitled Pediatric Gastroesophageal Reflux Disease: Developing Drugs for Treatment.
FDA accepts for priority review an AbbVie NDA for elagolix, an investigational, orally administered gonadotropin-releasing hormone antagonist for mana...
FDA clears a Butterfly Network 510(k) for what the sponsor describes as the worlds first ultrasound-on-a-chip based imaging system, the Butterfly iQ f...
FDA posts a guidance on De Novo Classification Process (Evaluation of Automatic Class III Designation) that provides recommendation on how to use the ...