Topic Paragraphs
FDA Launches Expedited Investigational New Drug Pilot

FDA Launches Expedited Investigational New Drug Pilot

Program seeks to accelerate the time it takes from identifying a drug to initiating a first-in-human clinical trial by partnering drug companies with qualified research institutions – The FDA is doing our part to ensure American patients continue to receive access to therapies first, while keeping scientific innovation and investment in America.

Featured Topics

Recalls
Report a Problem
Warning Letters
Consumer Updates
483s
EUAs
510Ks
Guidance Documents
Drug Databases
Import Program

FDA in Action

Good Clinical Practices Are Not Optional: The FDA’s Commitment to Human Subject Protections and Gold Standard Science in an Era of Global Clinical Research
FDA Approves New Engineered Viral Immunotherapy for Patients with Treatment-Resistant Advanced Melanoma
Supporting and Strengthening Domestic Drug Manufacturing
The FDA at 120: A Long, Distinguished History Protecting Americans
Accelerating and Modernizing Early and Late-Stage Clinical Development
Year 1 Goals in Reducing Animal Testing in Drug Development
Results from Largest-Ever Testing of Infant Formula in the U.S.
FDA PreCheck Pilot Program: Strengthening Domestic Pharmaceutical Manufacturing
Food Chemical Safety Post-Market Assessment Program and Reassessment of BHT, ADA

Press Announcements

September 15, 2026

FDA Launches Expedited IND Pilot, Begins Accepting Applications

September 04, 2026

FDA Takes Steps to Maintain Newborn Access to Life-Saving Starter Nutrition Products

September 04, 2026

FDA Grants Accelerated Approval to a New Breast Cancer Treatment

Products We Regulate

Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood, and Biologics
Animal and Veterinary
Cosmetics
Tobacco Products
Back to Top