1.1 Background The 2012 Food Drug Administration Safety and Innovation Act (FDASIA)
gave FDA new tools to encourage high quality manufacturing of pharmaceuticals and …

The Parenteral Drug Association (PDA) has answered a call by officials at FDA's Center for
Drug Evaluation and Research (CDER) to help define quality metrics that can be used by …

The purpose of the Conference on Advancing Product Quality, under the sponsorship of the
Food and Drug Administration (FDA) and Product Quality Research Institute (PQRI), is to …

Failures surrounding pharmaceutical quality, particularly with respect to product
manufacturing issues and facility remediation, account for the majority of drug shortages and …

The long awaited, anxiously anticipated FDA guidance on quality metrics was finally
distributed for comment on July 28, 2015. The official title of this guidance for industry is …

Abstract On September 16 and 17, 2014, the Food and Drug Administration (FDA) and
Product Quality Research Institute (PQRI) inaugurated their Conference on Evolving Product …

Since the US Food and Drug Administration (FDA) began monitoring the quality of
pharmaceutical manufacturing by enforcing current good manufacturing practices roughly …

The pharmaceutical regulatory landscape and pharmaceutical development have been
reshaped by International Council for Harmonisation of Technical Requirements for …

Purpose: Pharmaceutical manufacturers execute quality control operations and Good
Manufacturing Practices (GMP) to provide safe drugs. The Federal Drug and Food …

A Call to Action to Track Generic Drug Quality Using Real-World Data and the FDA’s Sentinel
Initiative | Journal of Managed Care & Specialty Pharmacy Skip to main content Site Logo …