Quality Systems

Articles

The cell therapy will be manufactured for each individual patient at BMS’ immunotherapy manufacturing facility in Bothell, WA, and will be launched across a network of treatment centers. 

FDA Approves Bristol Myers Squibb’s CAR T Cell Therapy Lymphoma Treatment

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

The selection of a new FDA commissioner has become a contentious issue in Washington, as the White House delays a decision and interest groups line up behind competing candidates. 

New Leadership for FDA Entangled in Politics

FDA sent a warning letter to Allay Pharmaceuticals for inadequate written procedures; inadequate out-of-specification testing; inadequate stability testing; and inadequate quality control oversight.

Florida Manufacturer Warned for Inadequate Written Procedures 

Videos

Representatives of industry organizations discuss crucial business, regulatory, science-based issues facing the industry.

Bio/Pharma Industry: Beyond Politics and the Pandemic

The agency is developing guidance to help manufacturers make changes to existing COVID-19 vaccines to treat new variants in the coronavirus.

EMA Guidance on Changes to COVID-19 Vaccines to Fight Variants

FDA considers regulatory flexibility to allow the agency and sponsors to adapt and pivot to changes in coronavirus. 

FDA Outlines Strategy to Address Virus Variants

FDA’s Vaccines and Related Biological Products Advisory Committee will meet on Feb. 26, 2021 to discuss the request for emergency use authorization for Janssen Biotech’s COVID-19 vaccine candidate.

FDA Sets Date for Advisory Meeting to Discuss Janssen COVID-19 Vaccine EUA

This article provides an overview of the key risks that can be associated with the use of secondary reference standards (RS) and illustrates scientific challenges associated with transitioning from pharmacopeial RS to secondary RS. 

The Value of Pharmacopeial Reference Standards

Shannon Parisotto, MBA, is the corporate senior vice president of Charles River Laboratories.

Accelerated drug development timelines must accommodate all crucial elements of nonclinical safety studies.  

Toxicology: Ensuring Drugs are Safe for People

FDA puts applications on hold as the agency limits alternative oversight methods. 

Regulatory Oversight and Compliance