The U.S. Food and Drug Administration (FDA) has just published a highly-anticipated draft guidance on the implementation of decentralized clinical trials (DCTs) for drugs, biologics, and medical devices. In the draft...more
On June 7, 2017, FDA issued a revised guidance document, Form FDA 3674 – Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions, to clarify when sponsors should submit Form FDA 3674...more
6/14/2017
/ Abbreviated New Drug Application (ANDA) ,
Certification Requirements ,
Clinical Trials ,
Food and Drug Administration (FDA) ,
Food and Drug Administration Amendments Act (FDAAA) ,
Guidance Update ,
Investigational New Drug Application (IND) ,
Medical Devices ,
Medical Research ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health Service Act ,
Regulatory Standards