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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 noted that agency officials will conduct a “stringent evaluation of product quality,” which includes determining whether manufacturing plants meet appropriate standards. Read More
Pharmaceutical experts sitting on advisory committees in the U.S. and UK aren’t required to disclose conflicts of interest dating back more than a year and differing public disclosure standards among entities can cause important industry ties to go unreported to the public, according to The BMJ. Read More
Provention Bio’s teplizumab, a monoclonal antibody the FDA is reviewing for delaying or preventing type 1 diabetes, should be approved because the benefits outweigh the risks, a divided Endocrinologic and Metabolic Drugs Advisory Committee said Thursday in a 10-7 vote. Read More
PhRMA has filed a lawsuit against HHS, pushing back against a final rule that the trade group contends would penalize drug manufacturers that provide financial assistance to patients. Read More
The U.S. Department of Justice (DOJ) has issued a subpoena to Eli Lilly, seeking documents related to its Branchburg, N.J., manufacturing plant, the site of employee whistleblowing that alleged quality control failures and the editing of certain findings to make them appear less serious. Read More
Belgian officials said the suspension would remain in effect “pending a more detailed benefit-risk analysis” by the European Medicines Agency. Read More
The Biden administration has reinstated the FDA’s Unapproved Drugs Initiative (UDI) that was shelved late last year in an HHS notice now being described as “legally and factually inaccurate.” Read More
The UK’s Competition and Markets Authority (CMA) is looking into whether AstraZeneca’s proposed $39 billion buyout of Boston, Mass.-based Alexion Pharmaceuticals would stifle competition. Read More
The FDA may decline to review COVID-19 vaccine Emergency Use Authorization (EUA) requests from drugmakers who neglect to meet with the agency during product development, the agency said in a revised guidance released yesterday. Read More
Drug safety surveillance, which saw a massive workload increase at the FDA’s Center for Drug Evaluation and Research (CDER) during the pandemic, hopes to pick up additional funding in the fiscal 2022 budget, said recently appointed center director Patrizia Cavazzoni. Read More
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