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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
FDA and industry are going back to the drawing board on proposals for safety labeling updates, according to the latest GDUFA III meetings, which also included discussions on supplement reviews and continued talks on proposals for data and technology modernization, among other topics. Read More
The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended eight new drugs for approval during its monthly meeting, including Bluebird Bio’s gene therapy for treating early cerebral adrenoleukodystrophy (CALD), a first for the treatment. Read More
In a declaration released Friday following the G20 Global Health Summit in Rome, world leaders called for voluntary patent licensing and technology transfers for COVID-19 vaccines and therapeutics. Read More
Despite a recent warning from HHS that drugmakers could face fines if they continue to hold back 340B drug discounts from clinics and hospitals serving low-income patients, Eli Lilly and AstraZeneca (AZ) appear determined to resist, filing motions in federal court against the department’s June 1 deadline. Read More
Only 23 Republicans voted against the bill Wednesday, a dramatic change from the 250 to 168 floor vote last week when a two-thirds majority was required. Read More
The application is supported mainly by positive phase 3 trial findings and the agency has set a target decision date for the drug in March 2022. Read More
A generic synthetic peptide must not contain a new peptide-related impurity that is more than 0.5 percent of the drug substance, the agency said. Read More