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The FDA is still working out details of a regulatory pathway for bispecific antibodies, but the agency has issued a guidance for developers that says, generally, the manufacturing processes should follow “standard monoclonal antibody development practices.” Read More
In a revised guidance that will stay in effect until the end of the pandemic, the FDA explained how it will deal with drug applications when it is unable to conduct an inspection because of travel restrictions. Read More
Emergent BioSolutions CEO Robert Kramer said that the FDA is currently assessing whether to allow the release of more than 100 million Johnson & Johnson (J&J) vaccine doses that were produced at Emergent’s beleaguered Bayview, Md., facility during the company’s highly publicized cross-contamination incident there earlier this year. Read More
The pharmaceutical industry should brace itself for a spike in drug recalls as companies begin returning to normal operations in the U.S. and the FDA looks to catch up on inspection-related activities, a research firm advised in a new report. Read More
The Government Accountability Office (GAO), in a letter to the HHS secretary, has reiterated that the agency needs to continue to prioritize its inspections backlog. Read More
The FDA’s latest biosimilar user fee negotiations with industry representatives focused on the agency’s proposals for a regulatory science pilot program and guidance on biosimilar interchangeability, as well as furthering discussions on several other topics. Read More
President Biden’s request for an additional $343 million in FDA budget authority for fiscal 2022 has been met with enthusiasm by the Alliance for a Stronger FDA, which lauds the proposed boost in agency funds but cautions that Congress could become entangled in debates about caps for overall federal funding this year. Read More
Six states have passed laws to create importation programs that aim to lower costs by procuring cheaper foreign drugs, but the states need the FDA’s approval before they can implement their plans. Read More
A controversial bankruptcy settlement is moving forward in the sprawling opioid litigation against Purdue Pharma despite fierce resistance from dozens of attorneys general. Read More
With a Drug Supply Chain Security Act (DSCSA) implementation date set for 2023, the FDA has published four guidances designed to bolster efforts to identify and trace drugs as they move through the supply chain, including a final guidance clarifying product identifier requirements for drugmakers. Read More