RAPS

Omnibus brings new advanced manufacturing programs to FDA

Omnibus brings new advanced manufacturing programs to FDA The recently enacted ominous spending bill approved by Congress in late December directs the US Food and Drug Administration (FDA) to ...
RAPS

AI in drug manufacturing: Stakeholders call for harmonization, further guidance

A discussion paper released by the US Food and Drug Administration (FDA) on incorporating artificial intelligence (AI) and advanced manufacturing techniques into the pharmaceutical manufacturing ...
GEN

Mosaic’s Nanoneedle Granted Advanced Manufacturing Technology Designation for Gene Therapy Products

The FDA’s Center for Biologics Evaluation and Research (CBER) granted NanoMosaic’s request for an Advanced Manufacturing Technology (AMT) designation for its Nanoneedle technology for multiplex ...
JD Supra

FDA Issues Guidance on Alternative Tools for Assessing Drug Manufacturing Facilities in Pending Applications

On September 12, the US Food and Drug Administration (FDA) released guidance detailing its approach to using alternative tools, such as remote regulatory assessments (RRAs), information sharing with ...
JD Supra

FDA Launches PreCheck Program to Accelerate Onshoring of Drug Manufacturing Facilities

The FDA PreCheck program, launched in response to Executive Order 14293, is designed to streamline and expedite the construction and approval of domestic drug manufacturing facilities, aiming to ...
Business Wire

LumaCyte Launches Laser Force Cytology™ Academy after Training FDA Reviewers

CHARLOTTESVILLE, Va.--(BUSINESS WIRE)--LumaCyte, a trailblazer in advanced label-free cellular bioanalytical technology and instrumentation, proudly announces the launch of the Laser Force Cytology™ ...