Jill Wechsler

Success in combatting the pandemic depends on the ability of manufacturers to quickly and efficiently produce and distribute the huge quantities of vaccines demanded by the United States government and public health organizations around the world.

Manufacturers and regulators accelerate R&D and production of new vaccines and therapies.

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.

As part of the administration’s campaign to reduce the United States’ reliance on an increasingly global pharmaceutical supply chain and to minimize potential shortages for critical drugs, FDA has published a list of those drugs and medical products considered critical for addressing public health emergencies.

Experts fear confusion over allocation processes, cold-chain requirements, and IT systems needed to bring a COVID-19 vaccine to market.

The much-anticipated meeting of FDA’s vaccine advisory committee this week is slated to address a number of critical issues related to testing and approval of vaccines to prevent COVID-19 infection.

Drug shortages and supply chain challenges bolster FDA efforts to promote modern manufacturing.

President Trump announced a revised initiative designed to reduce what consumers pay for prescription drugs, while also promising to protect coverage for pre-existing health conditions.

Fears about overly accelerated development programs has heightened demands for wider access to information on study protocols, statistical analysis plans, and early results.

The White House issued an executive order Sunday, Sept. 13, 2020 implementing a policy to link payments for medicines provided through Medicare to prices charged in other industrial countries.

Industry leaders insist they will maintain high standards for clinical trials and regulatory submissions for new vaccines and therapeutics to combat COVID-19.

Regulators strive to review flood of advanced treatments while also vetting COVID-19 vaccines.

FDA announced it had issued an emergency use authorization for convalescent plasma that would make it easier to provide this treatment to COVID-19 patients.

The White House initiative to encourage production of essential medicines in the United States calls on FDA to set the parameters for and implement main aspects of the program.

As biopharma companies and research institutes advance the development of COVID-19 vaccines, policy makers and health officials are debating strategies for ensuring fair and equitable distribution of anticipated preventives.

An increasing number of warning letters shows that FDA is observing more problems with pharmaceutical contract manufacturing.