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

Articles

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

Gold Standards Remaining Gold Standards for Germany's HTA

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.

Europe's COVID Vaccine Bids Still Veiled in Secrecy

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.

COVID-19 Vaccine Concerns Prompt Clinical Trial Transparency

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

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.

Regulatory