Healthline

The FDA Development and Approval Process for Medications and Medical Devices

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
JD Supra

Conditional Approval Proposals for FDA: Current Context and Potential Ramifications

Drug approval is unequivocally the linchpin to any drug development effort and, given the role of the US market in the global marketplace, the drug approval standard employed by FDA remains a ...
Becker's Hospital Review

New FDA office will update drug approval process

The FDA plans to establish the Office of Drug Evaluation Science to improve and modernize the review process for new medications, according to STAT. The new office will help develop a standardized ...
Becker's Hospital Review

Lawmakers seek to accelerate approvals with Reauthorized Generic Drug User Fee Act

The Food and Drug Administration released a report Thursday containing proposals for reauthorization of the Generic Drug User Fee Act that would accelerate the agency’s drug approval process. Here are ...