The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) continues to extend what it calls temporary “flexibilities” in good manufacturing practice (GMP) to drugmakers to help out with the exceptional…
FDA Commissioner Stephen Hahn said that the agency will resume domestic inspections this month using a new risk assessment system developed in response to the pandemic. Source: Drug GMP Report
HHS and the Department of Defense have signed their largest deal to date under Operation Warp Speed — a $1.95 billion contract with Pfizer and BioNTech for large-scale production and…
India-based Glenmark Pharmaceuticals says its antiviral favipiravir has shown promise as a COVID-19 treatment in mild to moderate patients. Source: Devices & Diagnostics Letter
The Leaf received 510(k) clearance from the FDA in October 2019. Source: Devices & Diagnostics Letter
Genfit said it will now focus on developing the drug for the treatment of primary biliary cholangitis, a chronic liver disease. Source: Devices & Diagnostics Letter
Among other questions, the lawmakers asked what resources the agencies are using to assess the extent of the scams and what actions they are taking against those involved. Source: Devices…
The FDA required a boxed warning for the drug because of its potential for misuse and abuse. Source: Devices & Diagnostics Letter
The drug was generally well tolerated, with no serious adverse events or deaths, the company said. Source: Devices & Diagnostics Letter
The vaccine generated a strong immune response in preclinical studies. Source: Devices & Diagnostics Letter