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© 2021 MJH Life Sciences and BioPharm International. All rights reserved.
© 2021 MJH Life Sciences™ and BioPharm International. All rights reserved.
Complex manufacturing processes pose challenges for final product inspection.
Transporting large quantities of COVID-19 vaccines pose challenges.
Cleaning’s low-tech image is evolving to science-based limits and statistical approaches.
January 27, 2021
Accelerated drug development timelines must accommodate all crucial elements of nonclinical safety studies.
January 25, 2021
The broader national strategy sets seven goals, some fairly general, such as building public trust, safely reopening schools and businesses, advancing racial and ethnic equity, and restoring US global leadership.
January 19, 2021
Since FDA authorization of two innovative mRNA vaccines to combat COVID-19 in late 2020, 30 million doses have been distributed, but only 4 million people were vaccinated in December 2020, and just 13 million have received shots so far.
January 14, 2021
As the Biden administration readies to take over the reigns of government, top administration officials continue to rush through new rules and decisions that appear to challenge the independence and effective operations of FDA.
January 11, 2021
The draft guidance document offers developers of these treatments information regarding product development, preclinical testing, and clinical trial design.
January 07, 2021
The vetting and authorizing of important new therapies remained productive in 2020, despite the need to devote considerable resources to dealing with COVID-19 related approvals and policies.
FDA puts applications on hold as the agency limits alternative oversight methods.
The European Commission has granted a conditional marketing authorization to Moderna for its COVID-19 vaccine.
January 05, 2021
Amid pressure to get more vaccines administered faster, FDA pushes back against changes in dosing regimens.
January 01, 2021
Clear understanding of what exactly the biomolecule entails is essential.
The incoming administration faces key decisions on drug testing and access as well as vaccine distribution challenges.
Updating the quality technical agreement will clarify any expectations and limitations, says Siegfried Schmitt, vice president, Technical at Parexel.
December 30, 2020
President Trump signed the COVID-19 package, which appropriates $2.3 trillion to finance the federal government through September 2021 and provides support for individuals and entities suffering from the economic crisis wrought by the pandemic.
December 23, 2020
The agency is organizing a second public meeting on January 8, 2021 to discuss the assessment, approval, and roll-out of new COVID-19 vaccines.
December 21, 2020
A decision by the European Commission on conditional marketing authorization for the European Union’s first COVID-19 vaccine is expected soon.
The guidance provides information on review timelines during the COVID-19 pandemic.
December 18, 2020
The new guidance provides information on how sponsors should interact with the agency regarding complex innovative trial design proposals.
FDA is expected to issue Emergency Use Authorization for Moderna’s vaccine, enabling immediate distribution.
The agency is answering frequently asked questions about the Pfizer–BioNTech COVID-19 vaccine on its website.
December 16, 2020
The product represents a first-of-its-kind intentional genomic alteration in a line of domestic pigs that may be used for human therapeutics.