CDERs Office of Prescription Drug Promotion proposes to examine whether disclosures in direct-to-consumer and healthcare provider-targeted advertising...
FDA announces a 9/23 symposium entitled FDA-PDS Symposium X Data Sharing; The Future of Clinical Trial Data SharingThe Art of the Possible.
FDA says it has initiated on-site inspections at Philips Respironics manufacturing facilities to assess compliance with regulatory requirements follow...
Federal Register notice: FDA announces a public workshop entitled Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mi...
FDA grants breakthrough therapy designation to Boehringer Ingelheim and Lillys Jardiance for treating heart failure with preserved ejection fraction.
Federal Register notice: FDA makes available a draft guidance entitled S12 Nonclinical Biodistribution Considerations for Gene Therapy Products.
Federal Register notice: FDA reopens the comment period on a draft guidance entitled ICH Q12: Implementation Considerations for FDA-Regulated Products...
Federal Register notice: FDA seeks comments on an information collection extension entitled Generic Clearance for Quantitative Testing for the Develop...