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© 2020 MJH Life Sciences and BioPharm International. All rights reserved.
© 2020 MJH Life Sciences™ and BioPharm International. All rights reserved.
How a monograph, general notices, and general chapters relate to good manufacturing practices.
Careful analysis of CMC factors ensures no problem areas are overlooked.
November 24, 2020
FDA granted fast track designation for AB201, a small recombinant protein that is a potent, selective inhibitor of tissue factor, for the potential treatment of COVID-19.
The EC’s approval was based on positive results from a Phase III clinical trial that demonstrated a statistically significant and clinically meaningful improvement in patients compared to chemotherapy.
November 18, 2020
The agency recommended treatments for a variety of cancers as well as treatments for glaucoma and influenza.
The guidance was published in connection with a safety monitoring plan for COVID-19 vaccines.
The agency’s safety monitoring plan outlines how information that emerges after the authorization of COVID-19 vaccines will be collected and reviewed.
The guidelines are part of the independent control of pandemic COVID-19 vaccine batches.
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
Experts examine the role technology can play in quality programs at the 2020 Bio/Pharma Virtual Congress.
November 03, 2020
The document provides analytical strategy options for the control of recombinant viral vectored vaccines to support COVID-19 vaccine developers.