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The FDA accepted the BLA for the drug in February for priority review, and the agency was originally expected to approve the drug by Aug. 17, 2020. Read More
The former director of HHS’s Biomedical Advanced Research and Development Authority (BARDA) has filed a whistleblower complaint claiming he was removed from his role as head of the federal vaccine development agency in part for pushing for a more aggressive response to COVID-19. Read More
To keep prescription drugs moving smoothly through the supply chain during the pandemic, the FDA released emergency final guidance exempting certain COVID-19 products from tracing and identification requirements. Read More
CDER laid out how it will review newly identified safety signals (NISS) for marketed drugs, in a new Manual of Policies and Procedures (MAPP). Read More
The European Medicines Agency has introduced a new system for reporting drug shortages and potential supply chain disruptions as the COVID-19 pandemic takes a toll on the stock of some critical medicines. Read More
The European Medicines Agency (EMA) recommended that good manufacturing practice (GMP) certificates for drugmakers be extended until the end of 2021 to avoid potential drug supply-chain disruptions during the pandemic. Read More
A Federal appeals court has upheld the FDA’s denial of a new drug application for an abuse-deterrent formulation of oxycodone from Pharmaceutical Manufacturing Research Services (PMRS). Read More
The agency noted the positive results from a National Institutes of Health clinical trial of the antiviral drug, but said it is too early to draw any conclusions. Read More
To keep prescription drugs moving smoothly through the supply chain during the pandemic, the FDA released emergency final guidance yesterday exempting certain COVID-19 products from tracing and identification requirements. Read More
Pharmacy benefit manager (PBM) reimbursements to pharmacies have failed to keep up with price increases for generic drugs, according to an analysis by 3 Axis Advisors, a consulting group that tracks drug supply-chain inefficiencies and pricing. Read More