Federal Register notice: FDA announces an 8/11 public meeting entitled Independent Third-Party Assessment of IND FDA-Sponsor Communication Practices i...
Federal Register notice: FDA announces an 8/13 Oncologic Drugs Advisory Committee meeting to review a Mesoblast BLA for Remestemcel-L for acute graft-...
FDA places a Pieris Pharmaceuticals Phase 1 study of cancer drug PRS-343 on partial clinical hold while the company conducts an additional in-use and ...
Federal Register notice: FDA withdraws approval of 10 ANDAs from multiple applicants after they notified the agency that the drug products were no lon...
Federal Register notice: FDA makes available a draft guidance entitled Appeal Options Available to Mammography Facilities Concerning Adverse Accredita...
FDA issues a draft guidance on quality considerations for clinical research related to developing drugs containing cannabis or cannabis-related compou...
FDA offers a second funding opportunity to develop core sets of clinical outcome assessments for four areas.
Drug company executives try to reassure a House committee that FDA will not lower its standards to approve a Covid-19 vaccine.