Jill Wechsler, ACT's Washington Correspondent

Despite challenges and disruptions posed by the coronavirus pandemic this past year, FDA annual reports on drug regulatory programs and policies confirm successful efforts for meeting review time frames and updating policies and programs.

R&D on medical treatments lags notable success with vaccines.

FDA emphasizes importance of inclusion in trials.

President unveils lengthy program for combatting COVID-19 immediately following inauguration.

The selection of a new FDA commissioner has become a contentious issue in Washington. Jill Wechsler reports.

With Democrats controlling Congress and the White House, expectations are high that policy makers will revise certain coverage and payment policies. Jill Wechsler reports.

Efforts by the Trump administration to limit FDA’s authority have rekindled calls for FDA to become an independent regulatory agency.

Applications put on hold as agency limits alternative oversight methods.

CDER's process for vetting and authorizing important new therapies remained strong and productive last year, despite the need to deal with COVID-19 related approvals and policies.

Looking back on regulatory challenges created by COVID in 2020.

FDA’s Vaccines and Related Biological Products Advisory Committee addresses issues related to testing and approval of potential COVID vaccines.

President-elect Biden has announced initiatives to combat the widening coronavirus pandemic including a 13-member COVID advisory board.

This week's much-anticipated meeting of FDA’s vaccine advisory committee will address critical issues related to the testing and approval of vaccines to prevent COVID-19 infection.

Sponsors are beginning to make their study protocols public as pressure for a COVID-19 vaccine rises.

FDA has published updated Emergency Use Authorization (EUA) requirements for new coronovirus preventives.

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

A look at how real world data and real world evidence are shaping more decentralized trial designs for potential COVID-19 treatments.

As biopharma companies and research institutes advance the development of promising vaccines against COVID-19, policy makers and health officials have intensified deliberations on strategies for ensuring fair and equitable distribution of anticipated preventives.

FDA to resume “prioritized domestic inspections” for certain regulated products put on hold by COVID-19.

Despite the rush for an effective COVID-19 therapy, biotech industry leaders insist rigorous research and complete data will be the standard preceding approvals.

Despite the rush for an effective COVID-19 therapy, biotech industry leaders insist rigorous research and complete data will be the standard preceding approvals.

Officials struggle to maintain the credibility of its drug regulatory process after accusations of intentionally delaying COVID-19 vaccine testing for political reasons.

FDA to resume “prioritized domestic inspections” for certain regulated products put on hold by COVID-19.

The increasing need for treatments to slow the global spread of COVID-19 has prompted greater cooperation between drug regulatory authorities around the world.

A look at how real world data and real world evidence are shaping more decentralized trial designs for potential COVID-19 treatments.

As biopharma companies and research institutes advance the development of promising vaccines against COVID-19, policy makers and health officials have intensified deliberations on strategies for ensuring fair and equitable distribution of anticipated preventives.

FDA's plans to resume inspections of some US regulated facilities this week are not clear on which sites will be visited and what alternative oversight strategies will apply where on-site inspections are difficult.

The FDA has released a new guidance which outlines recommendations for quality and safety in potential COVID vaccines as they move through trials.

The need for treatments to combat the spread of COVID-19 is promoting greater cooperation among drug regulatory authorities around the world, with FDA officials communicating more frequently with their counterparts in Europe, Canada, Japan and other nations through established programs and agreements.

The need for new therapies to treat coronavirus patients has prompted an onslaught of advisories from FDA clarifying how sponsors should assess and implement changes necessary to fit this new reality.