Regulatory

Early Vaccine Authorization Raises Ethical & Logistical Challenges for Trial Sponsors

October 18, 2020

This week's much-anticipated meeting of FDA’s vaccine advisory committee will address critical issues related to the testing and approval of vaccines to prevent COVID-19 infection.

Industry Backs Clear FDA Standards for COVID Vaccine Authorization

October 08, 2020

FDA has published updated Emergency Use Authorization (EUA) requirements for new coronavirus preventives.

COVID-19 Vaccine Concerns Prompt Clinical Trial Transparency

September 20, 2020

With all eyes on efforts to research and test potential vaccines and therapies to combat the coronavirus pandemic, fears about overly accelerated development programs has heightened demands for wider access to information on study protocols, statistical analysis plans, and early results.

Trump Escalates Drug Pricing War

September 13, 2020

President Trump has taken on the pharma industry in a surprise move making significant cuts in reimbursement for drugs covered by Medicare.

FDA’s “Gold Standard” Critical for Biopharma R&D

September 07, 2020

Industry leaders insist they will maintain high standards for clinical trials and regulatory submissions for new vaccines and therapeutics to combat COVID-19.

FDA Caught in Political Crossfire

August 24, 2020

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