FDA publishes an International Council For Harmonization guidance entitled E9 (R1) Statistical Principles for Clinical Trials: Addendum: Estimands and...
Federal Register notice: FDA publishes six medical device classification notices.
Federal Register notice: FDA reopens the comment period to allow additional time for comments related to a workshop on Voluntary Medical Device Manufa...
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FDA releases a draft guidance on Assessing User Fees Under the Generic Drug User Fee Amendments of 2017.
Federal Register notice: FDA makes available a draft guidance entitled Pediatric Gastroesophageal Reflux Disease: Developing Drugs for Treatment.