Topic

Kate Coleman is Principal Quality and Compliance Consultant with Arriello Ireland.

Articles

The ICH Q9 revision clarifies QRM implementation for the pharmaceutical industry and expands descriptions of methodology, formality, and risk-based decision making to provide the industry with a solid base from which to build their own QRM programs.

The ICH Q9 Revision and a Renewed Focus on Quality Risk Management Fundamentals 

Cheryl Barton is director of PharmaVision, 

Renewing the UK Voluntary Pricing Scheme 

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

FDA and industry face unprecedented political and policy challenges.

Signing Off from Washington 

Mike Hennessy Jr. is the President and CEO of 

Pharmaceuticals are entering a transition into a far more complex era of patient therapies, and patient segmentation.

The Dislocation of Progress

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Final product inspection results should be included as part of the batch release documentation, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.

Final Product Inspection: Making the Most of Your Processes

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

Exagamglogene autotemcel seen as synechdoche.

New Medicines, Markets, and Manufacture: CRISPR for Sickle Cell Disease and β-thalassemia

Consent decrees were issued against Evig LLC, of St. George, Utah, and Premium Production LLC, of St. George, Utah, for unapproved dietary supplements.

Consent Decrees Entered Against Utah Supplement Manufacturer and Distributors

The US District Court for the District of Arizona entered into consent decree against Smart Women’s Choice and its CEO to stop the company from distributing unapproved contraceptive drugs.

Consent Decree Entered Against Arizona Company

Adzynma provides a replacement for low levels of the ADAMTS13 enzyme in patients with congenital thrombotic thrombocytopenic purpura.

FDA Approves First Recombinant Treatment for Rare Blood Clotting Disorder

Recommended medicines include treatments for generalized myasthenia gravis, glioma, neovascular age-related macular degeneration, and more.

Quality Systems