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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.

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. 

Demystifying Submissions of eCOA Documentation for Ethics Review: Are We Making Submissions More Difficult than Necessary?

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.

The RACE for Children Act Takes Effect This Month

A look at how real world data and real world evidence are shaping more decentralized trial designs for potential COVID-19 treatments. 

Innovative Clinical Trial Designs Emerge from Pandemic

ERT Introduces Compliant Respiratory Solution

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.

Global Regulatory Collaborations Aim to Speed Access to New Vaccines & Drugs

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