Dr. Goodenowe Dietary Therapeutics LLC announces FDA-governed development pathway for nutrient-based compounds

Plasmalogen precursors for Alzheimer’s are named as first program candidate There are nutrients and dietary compounds ...
Fox Business

AI and machine learning may speed drug development, manufacturing: FDA

The Food and Drug Administration (FDA) published a pair of discussion papers this week in an effort to outline areas artificial intelligence and machine learning may help in manufacturing ...
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, ...

FDA chief warns US is losing ground to China in early drug development, calls for faster trial approvals

Makary pointed to three bottlenecks: hospital contracting; ethical reviews and approvals; and the Investigational New Drug applications process ...

BioRestorative Announces Positive Outcome from Type B Meeting with FDA

BioRestorative completed a Type B meeting with the U.S. Food and Drug Administration (“FDA”) regarding a potential accelerated Biologics License ...
WLWT

FDA to streamline approvals for generic biological drugs in latest move targeting health costs

The U.S. Food and Drug Administration will take steps to streamline the process to develop generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to ...
Business Wire

Kemwell Biopharma Facility in Bengaluru Successfully Completes U.S. FDA Inspection for Commercial Drug-Product Manufacturing

BENGALURU, India--(BUSINESS WIRE)--Kemwell Biopharma Pvt Ltd (“Kemwell”), a leading global biologics Contract Development and Manufacturing Organization (CDMO), announced today that its drug-product ...