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

Applying Pre-Pandemic Benchmarks to Assess Future Speed Strategies

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.

Debate Accelerates Over Who Gets COVID Vaccine First

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

FDA May Delay Approval of Drugs Where Necessary Inspection is Not Feasible

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

FDA’s ‘Gold Standard’ Critical for Biopharma R&D

Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.

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."

EU Planning to Respond to Drug Innovation With Smarter Regulation by 2025

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

FDA Caught in Political Crossfire

FDA May Delay Approval of Drugs Where Necessary Inspection Is Not Feasible

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. 

C-Suite Survey Underscores Digital Technology’s Growing Role in Clinical Trials

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

EMA Looks to Its Image

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

Regulatory