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 ...
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, ...
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 ...
Pharmaceutical Technology on MSN

FDA’s commissioner vouchers prompt questions about award process

Despite the FDA’s CNPV scheme generating high interest, the process around how voucher awards are prioritised remains unclear ...
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 ...

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 ...
News Medical

FDA grants Breakthrough designation to Dthera Sciences' development-stage product for Alzheimer's

Dthera ™ Sciences, the leading digital therapeutic company focusing on the elderly and individuals with neurodegenerative diseases, announced today that the U.S. Food and Drug Administration (FDA) has ...