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November 24, 2020
HMA and EMA have released a joint statement on the appropriate route for companies to submit marketing authorization applications and the approval processes for vaccines.
November 18, 2020
EDQM announced three new Official Control Authority Batch Release guidelines that describe the tests to be performed by Official Medicines Control Laboratories in the European Union OCABR Network.
The agency recommended treatments for a variety of cancers as well as treatments for glaucoma and influenza.
November 12, 2020
The first public announcement from the Biden-Harris transition team was to name members of a COVID-19 advisory board charged with initiating policies and actions to combat the fast-rising infection rate in the United States
November 06, 2020
Opposition to IP protection for COVID-19 vaccines, therapies, tests and other technologies may only prevent eradication and treatment of the disease.
November 04, 2020
At the 2020 Bio/Pharma Virtual Congress, experts discuss the importance of characterizing excipients to ensure quality, safety, and effective performance.
Experts examine the role technology can play in quality programs at the 2020 Bio/Pharma Virtual Congress.
November 03, 2020
Nostrum Laboratories is recalling Metformin HCl Extended Release Tablets because of NDMA above the acceptable daily intake limit.
Recent industry guidance aims to anchor rapid COVID-19 vaccine development in good manufacturing practice protocols.
November 02, 2020
Siegfried Schmitt, vice president, Technical at Parexel, offers insight into FDA’s guidance on performing operations during COVID-19.