Quality Systems

Feliza Mirasol is the science editor for 

Articles

RoslinCT will manufacture Vertex Pharmaceuticals’ CRISPR-based gene therapy, Casgevy, recently approved for treating sickle cell disease and β thalassemia.

RoslinCT to Manufacture CRISPR-Based Gene Therapy Casgevy

The new advisory committee will provide the agency with technical and scientific advice and recommendations on potential treatments for genetic metabolic diseases.

FDA Announces Advisory Committee for Genetic Metabolic Disease Treatments

Sanofi has issued a statement expressing its disappointment with FTC’s decision to block an exclusive licensing agreement with Maze Therapeutics for a rare disease drug candidate.

Sanofi to Terminate Rare Disease Drug Licensing Agreement with Maze Therapeutics in Wake of FTC’s Challenge

Regulators in the European Union have published the first version a list of critical medicines in the EU to avoid potential shortages.

List of Critical Medicines Published in EU

The agency released two guidance documents on the interim policy on compounding using bulk drug substances for both outsourcing and non-outsourcing facilities.

FDA Releases Compounding Guidance

The medicines, levetiracetam and clobazam, may a cause life-threatening reaction to patients if not caught and treated quickly. 

FDA Warns of Rare but Serious Drug Reaction to Antiseizure Medicines

Kari Miller is senior director, Product Management, QMS, IQVIA.

Eradicating paper-based workflows and standalone solutions operating in isolation provides a good starting point to update quality management processes.

Revitalizing Quality Management Processes through Digitalization

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

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.

Regulatory Oversight and Compliance