regulatory guidance

FDA Publishes New Filing Checklists to Prevent Drug Submission Delays

1 month ago talkbio0Tagged Abbreviated New Drug Application, Complete Response Letters, drug application, filing checklist, New Drug Application, regulatory guidance, submission delays, United States Food and Drug Administration

FDA; filing checklist; drug application; submission delays; New Drug Application (NDA); Abbreviated New Drug Application (ANDA); Complete Response Letters; regulatory guidance

FDA Launches New Submission Program for Rare Disease Gene Therapies via CDER and CBER

3 months ago talkbio0Tagged Accelerated, Approved, CBER, CDER, gene therapy, Hereditary Diseases, Infrequent, RDEP, regulatory guidance, submission program, United States Food and Drug Administration

CDER; CBER; rare disease; gene therapy; FDA; submission program; accelerated approval; RDEP; regulatory guidance; rare genetic disorders

Rethinking Clinical Trial Data in the Era of Decentralization: Key Trends and Challenges (2025)

4 months ago talkbio0Tagged Artificial Intelligence, Clinical Trials, Data Integration, Data Quality, DCT gene, decentralized, Diversity, Preventive monitoring, regulatory guidance, Remote, risk-based oversight, trials

decentralized clinical trials; DCT; data quality; patient diversity; remote monitoring; AI in trials; data integration; risk-based oversight; clinical trial data; regulatory guidance