As part of the Trump Administrations national public health emergency declaration against opioid abuse, FDA commissioner Scott Gottlieb says the agenc...
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FDA releases a draft guidance on Assessing User Fees Under the Generic Drug User Fee Amendments of 2017.
Federal Register notice: FDA makes available a draft guidance entitled Pediatric Gastroesophageal Reflux Disease: Developing Drugs for Treatment.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 ...