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

Articles

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

COVID-Related Changes Have Implications for Public Acceptance of Innovation

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

Early Vaccine Authorization Raises Ethical and Logistical Challenges for Trial Sponsors

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

FDA Reassurances Always Go a Long Way

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.

Regulatory