Attorney Douglas Farquhar says FDA speakers at a GMP conference indicated that domestic drug facility inspections are back at operational levels.
FDA warns Baltimore, MD-based Emergent BioSolutions about repeat CGMP violations in its manufacturing of finished drugs.
FDA publishes a regional implementation guide for an International Council on Harmonization document on electronic transmission of individual case saf...
FDA accepts for review a Roche supplemental BLA for Polivy (polatuzumab vedotin-piiq) in combination with Rituxan (rituximab) plus cyclophosphamide, d...
FDA accepts for priority review an AstraZeneca supplemental NDA for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone...
Federal Register notice: FDA establishes a docket to solicit comments on the content of Appendix A in the 7/2018 guidance for industry entitled ANDA S...
A new drug pricing analysis finds that for drugs launched so far this year, their median pricing ($257,000) is 43% more than the median pricing of dru...
FDA issues Emergent BioSolutions an 8/10 Warning Letter after a February inspection cites GMP issues at its Camden, MD manufacturing facility.
