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.

FDA Releases Psychedelic Drugs Draft Guidance

June 26, 2023

FDA’s new draft guidance outlines key considerations for psychedelic drug development programs.

FDA Releases Updated COVID-19 Vaccine Guidelines

June 21, 2023

The new guidelines contain formulation recommendations for vaccines launching in autumn 2023.

FDA Launches Pilot Program Using Cancer Biomarkers to Mitigate Risk

June 21, 2023

FDA’s new voluntary pilot program is designed to help clinicians select appropriate cancer treatments for patients.

Long-Admired PEPFAR Program Caught in Abortion Debate

June 16, 2023

There is concern that debates will delay the five-year reauthorization of PEPFAR under review by Congress.

Merck Files Lawsuit Against US Government

June 08, 2023

The complaint alleges that Medicaid price controls implemented in the Inflation Reduction Act will negatively impact biopharmaceutical innovation.

MilliporeSigma Invests €35 Million to Strengthen Biosafety Testing in Scotland

June 07, 2023

Under the €35 million (US$37 million) investment, MilliporeSigma will expand its sites in Glasgow and Stirling, Scotland, to increase biosafety testing for drug development and commercialization.

Medicare Still Won’t Pay for Alzheimer’s Drugs without Confirmatory Data

June 05, 2023

Reimbursement for Alzheimer's medicines still will occur only with the completion of studies to support full FDA approval.

FDA Proposes Streamlined Medication Handouts

June 05, 2023

FDA has published a new system for providing basic and essential information on patient use of drugs and certain biologic products.

Facing the Future of Aseptic Manufacturing

June 02, 2023

Manufacturers must figure out how flexible they need to be to meet the numerous new requirements of the changing therapeutic and regulatory landscapes.

EMA Overhauls the Medicine Legislative and Regulatory Framework

June 02, 2023

What implications will EMA’s recent regulatory reform have on pharma?