Vanda asks the U.S. Court of Federal Claims to rule that FDA deliberately released confidential commercial information and trade secrets from two Vand...
Federal Register notice: FDA corrects a 4/12 notice about a final guidance entitled A Risk-Based Approach to Monitoring of Clinical Investigations Qu...
Federal Register notice: FDA creates a public docket to collect comments on methodological challenges related to patient experience data associated wi...
Federal Register notice: CDERs Office of Prescription Drug Promotion proposed to conduct a study on Perceptions of Prescription Drug Products with Me...
Federal Register notice: FDA sends OMB an information collection extension entitled Certification of Identity for Freedom of Information Act and Priva...
With the 5/2 posting of five deemed final orders, FDA completes the process of posting 33 deemed final orders that was part of over-the-counter drug m...
FDA issues a partial clinical hold on Sun Pharmas Deuruxolitinib (CTP-543), a JAK inhibitor being evaluated for treating alopecia areata.
Federal Register notice: FDA announces a 6/14 public workshop entitled FDA Science Forum 2023.
