Quality Systems

Steps Towards Demystifying Risk-Based Decision Making

It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.

Computer Validation Confirms Evidence

Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.

Digitalization of QbD Risk Assessments

Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. ecosystem.

Top 10 Considerations when Meeting with Regulators

July 02, 2023

Preparation is essential for regulatory meetings—it not only crystallizes what is needed from the regulators, it helps them better understand the development programme and potential challenges.

Improvements to EMA’s PRIME Designation Scheme

July 02, 2023

Changes to PRIME scheme are set to drive greater harmonization across major pharmaceutical markets.

New Deal on the Horizon

July 02, 2023

The UK and EU have negotiated a new draft deal for Britain to re-join the Horizon Europe research programme.

Drug Shortages Continue to Plague FDA and Manufacturers

July 02, 2023

Problems continue despite actions by regulators to better prevent and address drug shortages.

The Inspection Result: Warning Letters and Form 483s

July 02, 2023

FDA Warning Letters and Form 483s can offer a path to better compliance, says Siegfried Schmitt, vice president, Technical, at Parexel.

Drug Pricing’s Static Changes

July 02, 2023

The debate surrounding drug pricing changes rages on.

FDA Approves UCB Generalized Myasthenia Gravis Treatment

June 30, 2023

UCB’s rozanolixizumab-noli is approved for treatment of generalized myasthenia gravis in certain adult patient groups.

FDA Approves Pfizer Human Growth Hormone Analog

June 29, 2023

FDA approved Pfizer’s once-weekly human growth hormone analog for treatment of growth failure in pediatric patients.

NCI Launches Persistent Poverty Initiative

June 29, 2023

The persistent poverty initiative aims to fight the cumulative effects of persistent poverty on cancer outcomes.

Gene Therapy for Duchenne Muscular Dystrophy Approved by FDA

June 27, 2023

The agency approved Elevidys to treat pediatric patients four through five years of age with Duchenne muscular dystrophy.