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Jill Wechsler is ACT's Washington Correspondent

Articles

Measures being mulled to reform the AA process and address public concerns around its risk-benefit payoff.

FDA, Congress Re-Examine Accelerated Approval Program

Quality metrics, more domestic production aim to avoid supply disruptions and drug shortages.

FDA Maps Strategies to Advance Pharmaceutical Quality

The US Congress approved a federal spending package that increases funding for a range of programs to advance health and medicine.

Federal Budget Bill Boosts FDA Funding, Supports New Research Institute

FDA emphasizes importance of inclusion in trials.

Diversity in Clinical Trials Gains Ground Amidst COVID

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.

Early Vaccine Authorization Raises Ethical & Logistical Challenges for Trial Sponsors

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

Shawn Singh, Chief Executive Officer of VistaGen Therapeutics, discusses the company's ongoing efforts to treat and help manage the anxiety symptoms related to the triggers and anxiety-related disorders COVID-19 provokes, and the FDA’s consensus on the design of their pivotal Phase III study of PH94B.

Pushing Late-Stage Treatments Forward in the Clinic  

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

Bruno Speder is head of clinical regulatory affairs, Clinical Research, SGS Life Science Services, Bruno.Speder@sgs.com.

A first vaccine against this coronavirus could still take some time to develop, but mRNA vaccine platforms could offer an early breakthrough.

Regulatory Considerations Surrounding Human Challenge Studies with the SARS-CoV-2 Virus

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.  