Regulatory Oversight and Compliance

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.

EMA Creates Mechanism for Support during Drug Shortages

October 25, 2023

The agency’s solidarity mechanism allows Member States to support each other when there is a shortage of a critical medicines.

FDA Finalizes Guidance on Development of COVID-19 Vaccines

October 24, 2023

The final guidance document was issued to assist bio/pharma companies in the clinical development and licensure of COVID-19 vaccines.

Lisata Therapeutics Announces EMA LSTA1 Orphan Drug Designation for Pancreatic Cancer Treatment

October 20, 2023

The designation will grant Lisata EU marketing exclusivity for 10 years after approval and protocol assistance from EMA.