Quality Systems

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?

A Four-Phased Approach for Evaluating a Quality Risk Management Activity

June 02, 2023

Using the four-phased method to assess QRM can ensure continual improvement and that regulatory requirements are met.

Impurities Testing of Drug Products

June 02, 2023

All aspects of a drug’s lifecycle should be considered when evaluating risk assessment for elemental impurities.

FDA Eyes New Strategies to Spur Gene Therapy Development

June 02, 2023

An increase in applications for gene therapies is putting stress on FDA’s resources.