OR WAIT null SECS
May 09, 2019
The new guidance was issued to assist applicants in determining which abbreviated pathway to take for submitting marketing applications.
The new guidance document discusses reproductive toxicity testing and labeling recommendations.
May 07, 2019
FDA sent a warning letter to Dong Yuan Technology Co., Ltd. detailing CGMP violations including failure to follow laboratory and process controls.
May 03, 2019
The agency is updating its warning requirements for eszopiclone, zaleplon, and zolpidem after reports of complex sleep behaviors.
The company is recalling one lot of Mycophenolate Mofetil for Injection, USP because of glass fragments found in a vial after reconstitution.
A data exchange program between GE Healthcare and Amgen aims to improve biologics manufacturing through analysis of how raw materials affect the process.
May 02, 2019
FDA inspections can create uncertainty. Supervision of the contract manufacturer is crucial in ensuring compliance.
New agency leadership is pressed to promote innovation while addressing safety and quality issues.
We need to understand both sides when it comes to audits, says Siegfried Schmitt, PhD, vice-president, technical, PAREXEL Consulting.
Knowing the source and understanding the impact on CQAs is crucial to optimum drug formulation and processing.