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© 2021 MJH Life Sciences and BioPharm International. All rights reserved.
© 2021 MJH Life Sciences™ and BioPharm International. All rights reserved.
Transporting large quantities of COVID-19 vaccines pose challenges.
Cleaning’s low-tech image is evolving to science-based limits and statistical approaches.
Planning and the proper use of technology facilitate effective remote auditing.
March 04, 2021
The European Medicines Agency and Health Canada have published clinical data used to support the authorization of Moderna’s COVID-19 vaccine.
The agency is working to identify and obstruct scammers looking to profit from the pandemic.
The European Medicines Agency has begun a rolling review based on laboratory and clinical studies of the Sputnik V (Gam-COVID-Vac).
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 need for real-time monitoring and control has spurred the development of new analytical tools.
March 01, 2021
Accelerated drug development timelines must accommodate all crucial elements of nonclinical safety studies.
Auditing distribution suppliers provides understanding and documentation of the services performed.
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 19, 2021
FDA issued a public statement and press release, along with a sharp warning letter rebuking AcelRx Pharmaceuticals for its messaging on painkiller Dsuvia.