Quality/GMPs

Articles

The objectives of the new opportunity are to improve the quality and/or use of RWD, promote better understanding of RWE study designs, and develop specific tools to evaluate aspects of RWE generation.

FDA to Support Potential Use of Real-World Data to Generate Real-World Evidence for Regulatory Decision-Making

Adam C. Fisher, Phd, is Director of Science Staff, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, FDA.

FDA backs the benefits of adopting continuous manufacturing, a strategy which has accelerated approval and launch timelines, and its Emerging Technology Program could be a helpful tool.

The Manufacturing Edge on Path to Market

Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.

Regulatory and Standard Setting Organizations Directory

Resources, Guidelines, and Guidance Documents Directory 

Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.

Resources, Guidelines, and Guidance Documents

Regulatory and Standard Setting Organizations

Global regulatory authorities have published a report describing the aligned positions on COVID-19 vaccine development, which were agreed upon by meeting participants of the second workshop on COVID-19 vaccine development.

Regulatory Authorities have Published a Report on COVID Vaccine Development

Rita C. Peters is the former editorial director of 

With some FDA inspections on hold, will the US drug supply maintain its quality standards? 

Regulatory/GMP Compliance, Emerging Markets