Quality Systems

INTERPHEX 2022 Highlights Packaging and QC

July 15, 2022

Exhibitors display innovations for parenteral and solid dose products.

FDA Regulation of Nonprescription Drugs in Spotlight

July 14, 2022

Application for OTC contraceptive highlights efforts to broaden access to medicines.

FDA Drug Regulation Challenged by Anti-Abortion Campaign

July 08, 2022

Some states look to block access to approved drugs.

LG Chem Renews License with Avacta for IND Studies

July 08, 2022

LG Chem has decided to proceed with IND-enabling studies and has renewed a license with Avacta.

Lab Digitalization: From Source to Scientist

July 06, 2022

Integrating digital technologies into lab environments can ease workflow and enhance data capture for researchers.

Material Management and the Impact on Extractables and Leachables

July 02, 2022

By understanding potential material change, the impact on patient safety can be understood and mitigated.

The European Union’s New Pharmaceutical Strategy for Europe

July 02, 2022

A new strategy aims to bring in legislative reforms that will impact medicinal product regulation within Europe.

FDA Advances Quality Initiatives to Combat Drug Shortages

July 02, 2022

Agency leaders are moving to develop a rating system to identify those drug manufacturers with more dependable production operations.

The Difference between Electronic Records Retention and Archiving

July 02, 2022

An SOP for electronic-records archiving is a regulatory requirement and good for business, says Siegfried Schmitt, vice president, Technical at Parexel.

FDA Recommends Inclusion of Omicron BA.4/5 Component for COVID-19 Vaccine Booster Doses

June 30, 2022

Following the recommendation of an independent vaccine panel, FDA is advising vaccine manufacturers to include an Omicron BA.4 and BA.5 component to their booster doses.