Regulatory Oversight and Compliance

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.

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.

Cosentyx Receives Expanded Approvals in EU for Use in Childhood Arthritic Conditions

June 29, 2022

The European Commission has approved Cosentyx for the treatment of various childhood arthritic conditions.

Xenpozyme Approved by EC for the Treatment of ASMD

June 29, 2022

The European Commission has approved Xenpozyme as the first treatment for ASMD.

FDA Releases Action Plan for Rare Neurodegenerative Diseases

June 29, 2022

The action plan will span over five years and will fulfill a requirement of the Accelerating Access to Critical Therapies for ALS Act.

Regulators Seek More Drug Effects Research Related to Pregnancy and Lactation

June 27, 2022

Regulators wish to expand and clarify methods for obtaining information on medicines used by or needed for pregnant and lactating individuals through clinical trials and postapproval studies.