Quality Systems

The Decline and Fall of the Clinician–Scientist

December 29, 2023

Clinician-Scientists are vital innovation spark plugs, accounting for 40% of Nobel awards in Physiology or Medicine, and two thirds of Big Pharma CSOs.

European Medicines Regulatory Network on Track to Meet Goals

December 27, 2023

The midterm report of the European Medicines Agencies Network Strategy finds that the network has strengthened and is on track to achieve its objectives.

A Record Year for Disease Elimination

December 26, 2023

WHO provides a look at the world’s health as the agency turns 75.

FDA Publishes Guidance on Real-Word Data

December 21, 2023

The final guidance document provides recommendations for designing a new registry or using an existing registry to support decisions regarding safety and effectiveness of a drug.

EMA and FDA Answer Questions About Breakthrough Therapies

December 21, 2023

The agencies published a joint guidance document regarding quality development for breakthrough therapies and PRIME programs.

EMA Publishes Guide for Use of AI in Medicine Regulation

December 18, 2023

The Multi-annual AI Workplan creates a strategy to maximize the benefits and manage the risks of artificial intelligence.

Compounding Overview: Primary Considerations in the Workplace

December 18, 2023

Technical, regulatory, and personnel considerations characterize pharmaceutical compounding.

FDA Issues Guidance on Clinical Pharmacology for Peptide Drugs

December 15, 2023

The guidance document discusses the impact of clinical pharmacology considerations on peptide drug development.

Consent Decree Entered Against Pharmasol

December 15, 2023

The US District Court for the District of Massachusetts entered a consent decree of permanent injunction against Pharmasol Corporation for distributing adulterated drugs.

RoslinCT to Manufacture CRISPR-Based Gene Therapy Casgevy

December 14, 2023

RoslinCT will manufacture Vertex Pharmaceuticals’ CRISPR-based gene therapy, Casgevy, recently approved for treating sickle cell disease and β thalassemia.