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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
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is relaxing some GMP requirements to help manufacturers overcome challenges during the COVID-19 pandemic. Read More
In an emergency final guidance released yesterday, the FDA agency said it is temporarily relaxing its regulations for repackaging and combining units of propofol during the COVID-19 pandemic. Read More
The FDA said sponsors of emergency-use injectors should include details in their marketing applications to show that the devices are reliable. Read More
Rick Bright, the ex-director of HHS’s Biomedical Advanced Research and Development Authority (BARDA), said yesterday that he was removed from his post because he pushed back against the administration’s promotion of two anti-malaria drugs to treat COVID-19. Read More