Regulatory Oversight and Compliance

FDA Publishes Guidance on Container Closure Systems for COVID-19

November 09, 2023

The document includes recommendations for the reporting and implementation of changes to container closure system components.

Key E&L Issues to Consider During Formulation (AAPS PharmSci 360)

November 03, 2023

Dujuan Lu, PhD, global leader—E&L, SGS Health Sciences, recommends some key issues that pharma manufacturers should consider when formulating products that require a medical device.

New Biologic Treatment for Hidradenitis Suppurativa Receives FDA Approval

November 03, 2023

This is the second biologic approved to treat HS, a painful and reoccurring skin disease.

European Commission Searches for Committee Experts

November 03, 2023

The EC is calling for interested parties for their safety and orphan drug committees.

Breathing Easier

November 02, 2023

A novel approach for safety assessments in inhalation drugs may avoid animal testing for drug products.

The EU AI Act

November 02, 2023

The EU’s AI Act is set to become the world’s first comprehensive legal framework for artificial intelligence.

Elicitation of Expert Knowledge and Probabilities for Controlling Subjectivity in Risk-Based Decision Making

November 02, 2023

More attention should be given to how expert opinions and judgments are elicited for reducing uncertainty in quality risk management and risk-based decision making.

FDA Provides Guidance on Remote Facility Evaluations

November 01, 2023

The guidance describes the agency’s procedures for performing remote interactive evaluations at drug manufacturing and bioresearch monitoring facilities.

FDA Approves Vaccine for Prevention of the Five Most Common Serogroups Causing Meningococcal Disease in Adolescents

October 30, 2023

PENBRAYA combines components from two meningococcal vaccines, Trumenba and Nimenrix.

FDA Approves Novel Therapy for Rare Form of Blood Cancers

October 26, 2023

The treatment has received Priority Review designation, as well as FDA Breakthrough Therapy designation and Orphan Drug designation.