Regulatory

COVID-19 pandemic forces compliancy within organizations following FDA’s 2018 revision of Good Clinical Practice in federal registry.

Battle for trust ensues as vaccines are set for approval.

COVID-19 pandemic shifts traditional process for medicine development in Europe.

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

The FDA hints that their increased speed in issuing guidances during the pandemic could become the new norm.

Declarations made by Beate Wieseler don't align with those of many regulators and HTA bodies in Europe and will prove tough to transform.

Though members of the industry have made reassuring comments about progress with candidate COVID vaccines, they acknowledge it could be next year, at best, before any real response would be available.

Though members of the industry have made reassuring comments about progress with candidate COVID vaccines, they acknowledge it could be next year, at best, before any real response would be available.

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

Study offers clues for installing rapid R&D tactics post-pandemic.

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.

Europe is aiming to improve its medium-term planning for citizens' health with an agenda that aims to "enable and leverage research and innovation in regulatory science."

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.

Findings from the most recent Biopharma Confidence Index show that the pandemic has substantially influenced biopharma executives’ expectations in key areas like artificial intelligence/machine learning and real-world evidence.

EMA has launched a "communication perception survey" looking for honest views from among the widest audience on how well it is doing.

Examining how to optimizing the time and effort of Ethics Committees to efficiently and effectively fulfill their human subjects protection remit.

An amendment to Pediatric Research Equity Act, as part of the 2017 FDA Reauthorization Act, goes into effect soon aiming to change the landscape and promote pediatric cancer drug development.

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.

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.

Jill Wechsler details the continued rise of incorporating the “patient experience” in drug development measures.