The FDA’s Office of Good Clinical Practice responds to inquiries on a variety of trial-related subjects, providing answers on the agency’s official regulations as well as best practices. The following is a selection of questions and answers excerpted from the CenterWatch publication, GCP Questions, FDA Answers. Read More

Sponsors and sites need to do a better job analyzing suspected adverse events before sending reports to the FDA, say two senior agency officials, who fear that the current over-reporting they see may lead to missing important safety signals. Read More

For more than a year, sponsors have been working with some form of decentralized trials (DCT) and are seeing more clearly how some protocols are benefitting — and some not — from specific elements of decentralization. Read More

When the FDA threatened penalties in April against a sponsor for failure to submit timely trial results to ClinicalTrials.gov, many saw it as a shot across the bow warning sponsors of the agency’s intention to get tough on violators of a rule intended to make trials more transparent and research findings more accessible to the industry and the public alike. Read More