News

JD Supra11d
AI Health Law & Policy: Complying with FDA GMP rules for AI-enabled diagnostic devices
The U.S. Food and Drug Administration (FDA) recently issued a Warning Letter citing a failure to obtain marketing authorization via a ...
Labroots5y
How a complete set of software and validation tools for microplate readers can help GMP/GLP labs meet FDA data integrity guidelines
Laboratories operating under GMP or GLP regulations must follow guidelines set by ... SoftMax Pro 7.1 GxP Software is Molecular Devices and its customers’ reply to the new FDA guidelines about data ...
technologynetworks1y
GMP-Grade Cytokines for Cell Therapy Research
GMP-grade cytokines are manufactured in compliance with Good Manufacturing Practice regulations, which involve a strict quality ... production technology services for monoclonal antibody drug ...
The Bakersfield Californian26d
Applied StemCell Announces Drug Master File Submission to the US FDA for their GMP-Grade iPSC Cell Line
to the U.S. Food and Drug Administration (FDA) for its ActiCells™ GMP Human Induced Pluripotent Stem Cell (hiPSC) line. This milestone underscores the company’s commitment to empowering ...
Business Wire29d
Medical Devices Post Market Surveillance and Complaint Handling Systems Course: U.S. FDA CGMP Expectations/Requirements (ONLINE EVENT/ON-DEMAND) - ResearchAndMarkets.com
What are the key components of a CGMP-compliant post-market surveillance ... under Section 522 of the Federal Food, Drug, and Cosmetic Act", Guidance, dated October 2022 21 CFR 822 - Implementing ...