Regulatory/GMP Compliance

Jan 26, 2018
By BioPharm International Editors
The Fluent Gx Automation Workstation from Tecan is suited for a variety of clinical and regulated laboratory applications.
Jan 23, 2018
By BioPharm International Editors
The FDA center released its list of planned guidance documents for the rest of the year.
Jan 23, 2018
By BioPharm International Editors
The latest continuing resolution funds the government for three weeks.
Jan 22, 2018
By BioPharm International Editors
Non-essential activities and new regulatory submissions are on hold until a federal government funding agreement is reached.
Jan 11, 2018
By BioPharm International Editors
The agency is requiring safety label changes to limit the use of prescription opioid cough and cold medicines in children younger than 18 years old.
Jan 05, 2018
By BioPharm International Editors
FDA noted in a recent inspection that American CryoStem was receiving and processing adipose tissue into a product called Atcell, and then marketing the product without agency approval.
Jan 03, 2018
By BioPharm International Editors
The agency published draft guidance on good practices for submitting abbreviated new drug applications.
Jan 01, 2018
BioPharm International
Enterprise-wide processes, procedures, and systems are the keys to data integrity and peace of mind, according to Siegfried Schmitt, PhD, principal consultant at PAREXEL.
Jan 01, 2018
BioPharm International
Open standards based on GAMP and GS1 will soon be released and more companies are moving beyond basic compliance.
Jan 01, 2018
BioPharm International
A review of 2017 advancements from the Open-SCS working group with Charlie Gifford, group technical director.
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