RAPS

FDA Outlines Product Development Process to Combat Wuhan Coronavirus

The US Food and Drug Administration (FDA) on Monday issued a statement explaining how the agency can facilitate the development of investigational products to diagnose, treat and prevent emerging ...
Stocktwits on MSN

NEONC receives FDA written feedback on NEO212 CMC development and capsule-to-tablet transition

FDA feedback provides detailed manufacturing and formulation requirements for continued late-stage development of NEO212CALABASAS, Calif., July 15, 2026 (GLOBE NEWSWIRE) -- NeOnc Technologies Holdings ...
MD&M East

Ten Steps to Speeding Product Development While Meeting FDA Mandates

The path to successful product development for medical device companies is rife with roadblocks. The recession has only added to the pressures of mounting regulatory requirements, particularly those ...
JD Supra

You Can’t Call It Cheatin’: FDA Draft Guidance Provides a Framework for Leveraging Prior Knowledge in Genome Editing Product Development

You can’t call it cheatin’, she reminds me of you,” the Gin Blossoms sang on their 1996 album Congratulations I’m Sorry. For sponsors ...
RAPS

New FDA Document Clarifies IND Process for Drugs, Biologics and Biosimilars

A new procedural document issued by the US Food and Drug Administration (FDA) instructs its staff on the best practices-known as Good Review Practices (GVPs)-used in the review of investigational new ...
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 ...
Computerworld

FDA Revamping IT Development Process

The U.S. Food and Drug Administration has launched a project to overhaul its application development process to provide management with a view into the agency’s IT projects. The 12-month project, ...
JD Supra

HHS “Operation TrialBlazer”: FDA Moves to Accelerate and Modernize Clinical Development

On June 22, 2026, the U.S. Department of Health and Human Services (HHS) announced the launch of Operation TrialBlazer, a coordinated effort ...
The Scientist

FDA Proposes Speedy “Plausible Mechanism Framework” for Rare Disease Drug Development

One year ago this week, Baby KJ received his very first infusion of a gene therapy made specifically for him. 1 He had a unique mutation that led to carbamoyl-phosphate synthetase 1 (CPS1) deficiency, ...