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March 15, 2021
The agency’s focus appears to be on generic drugs for the upcoming year.
Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.
March 04, 2021
The agency is working to identify and obstruct scammers looking to profit from the pandemic.
The guidance document provides recommendations for reporting and implementing changes to container closure system components consisting of glass vials and stoppers for sterile drug products.
March 02, 2021
The UK government is taking advantage of the new regulatory flexibility, afforded by Brexit, to boost the country’s competitiveness in pharma.
Auditing distribution suppliers provides understanding and documentation of the services performed, says Siegfried Schmitt, vice president, Technical at Parexel.
March 01, 2021
To prevent future production delays of critical products, the Biden administration is examining supply chain vulnerabilities for pharmaceutical ingredients as part of a longer-range consideration of products important to public health.
February 22, 2021
The agency issued guidance for developers of vaccines, diagnostics, and therapeutics to address variants of the COVID-19 virus.
February 17, 2021
FDA published recommendations on the use of COVID-19 convalescent plasma or investigational convalescent plasma during the pandemic.