Articles

A picture of wide manufacturing violations appears in a recently disclosed FDA form 483 report on a site visit to Emergent’s Baltimore vaccine plant.

FDA Inspectors Cited Critical Problems at Emergent Facility

Updated programs supporting the development and review of prescription medicines are being readied for approval by federal agencies and ultimately by Congress

FDA, Industry Move to Finalize New Drug User Fee Programs

A look at the issues in Europe affecting ongoing trials including data management, measures being taken by sponsors, and more.

COVID-19: A New Era for Clinical Trial Research in Europe?

New American Jobs Plan set to be funded by corporate taxes will affect biopharma industry.

Biden Infrastructure Package Would Boost R&D–and Corporate Taxes

Lan Fong, Founder and Principal Consultant at Avery Biopharma Consulting and Venture Partner at Congress Avenue Ventures, discusses her perspective on how the pandemic is shifting the clinical trials industry.

Pandemic Impact on Trials, Public Perception, and Decentralization

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

Rate of adoption in Europe for advanced diagnostics is falling behind that of others' globally.

Another European Gap that Needs to be Filled: Advanced Diagnostics

Valerie Powell, Vice President of Research Services at HealthiVibe, discusses her experience with obtaining patient insights and helping her clients apply them to trial design and conduct in a pandemic. 

Let’s Not Forget the Patient Perspective in Clinical Trials

FDA is reviewing the record of its accelerated approval program following recent withdrawals of certain key indications for several leading cancer therapies, based on the failure of post-approval studies to document extended benefits of treatment.

FDA Reviews Gains, Risks of Accelerated Approval Process

A new partnership, to be known as EP PerMed, aims to bring public and private sector interests together. 

Personalized Medicine Yet Again Expecting a European Boost

Federal Trade Commission to launch a broad review of drug-company mergers.

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