Regulatory

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.

FDA officials make efforts to better manage the increasing amount of applications for new drugs that treat disease in innovative ways and include new kinds of clinical research, starting with a plan to restructure the Office of New Drugs (OND) in the Center for Drug Evaluation and Research (CDER).

Provenance is at the heart of the discussion when it comes to the equation of privacy and provenance.

Jill Wechsler interviews FDA Commissioner Scott Gottlieb about his push for more efficient R&D to help lower drug prices.

The EU General Data Protection Regulation is the most important change in data privacy regulation in 20 years.

Meeting today’s complex regulatory demands when it comes to drug safety and pharmacovigilance can be especially challenging for small and medium-sized organizations. This report presents the benefits for these companies in outsourcing such activities to functional service providers (FSPs) during clinical trials and post-approval.

In this blog by Peter O'Donnell, the EU provides a report on the progress its made within the pediatric medicines regulation.

The rise of new drugs targeting rare disease ignites increased push for flexible R&D approaches and more collaboration on orphan drug designation and clinical trial design between global regulators.

The language in Europe's Regulation (EU) 536/2014 regarding ethical review of protocols is concerning.

European Parliament has voted through a resolution criticizing the performance of drug companies on pediatric medicines development. This resolution will punish drug companies who neglect to investigate possible pediatric applications of new medicines.

With a new administration in Washington, sponsors and regulators are weighing several initiatives that promise to reshape clinical research policies.