FDA Hits Pfizer Facility in India for Shoddy Sterility Testing
Pfizer was taken to task in an FDA warning letter over testing violations at its Visakhapatnam, Andhra Pradesh sterile injectable drug facility. Source: Drug GMP Report
EMA Creates New Drug Shortage Reporting System
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…
EMA Recommends Extending GMP Certificates Until End of 2021
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.…
COVID-19 Response
BTS Research is taking in animals for temporary housing from local vivariums BTS provides services in the following research animals: Rodents. Rabbits. Guinea pigs. Dogs NHP's. Contact us for more details.
J&J Partners With Emergent to Produce COVID-19 Vaccine
Johnson & Johnson is partnering with Emergent Biosolutions to scale up manufacturing of a COVID-19 vaccine. Source: Devices & Diagnostics Letter
FDA Eases Requirements for Repackaging of Propofol
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. Source: Devices…
Remdesivir Trial Data Leak Shows No Benefits in COVID-19 Patients
Results from a Chinese trial of Gilead’s antiviral remdesivir show no benefit in COVID-19 patients, according to data accidentally posted on the World Health Organization’s (WHO) website. Source: Devices &…
MHRA Temporarily Eases Some GMP Requirements
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. Source: Devices & Diagnostics Letter
FDA Approves Immunomedic’s Breast Cancer Treatment Trodelvy
The FDA previously granted the drug priority review, breakthrough therapy and fast- track designations. Source: Devices & Diagnostics Letter
FDA Approves Sanofi’s Meningococcal Vaccine
MenQuadfi will be available in a ready-to-use liquid formulation to allow healthcare providers to avoid vaccine reconstitution. Source: Devices & Diagnostics Letter
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