Quality Systems

Somnath Mishra, Somnath.mishra@shabas.net, is president at Shabas Solutions LLC.

William Hauck is senior associate at Shabas Solutions LLC.

Zachary Royal, is senior consultant at Shabas Solutions LLC.

Robert Michalik is advisor (Quality and Corporate Compliance) at Shabas Solutions LLC.

Articles

QMM is an evolutionary advancement in FDA’s quality management maturity initiative that provides industry with a viable methodology to assess and improve manufacturing quality and supply chain reliability. 

Introduction to Pharmaceutical QMM Model: QMM Assessment to Promote Pharmaceutical Operational Excellence

Cheryl Barton is director of PharmaVision, 

The European Human Medicines Directive and Regulation is due to be updated by the end of 2022, but what changes are on the cards?

Overhauling the Human Medicines Directive and Regulation 

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

Health crises, political tension, and budget concerns were major challenges.

Pandemic and Politics Shaped Pharma and FDA in 2022

CSL’s Hemgenix (etranacogene dezaparvovec) will cost approximately $3.5 million, making it the most expensive single-use medicine in the United States.

FDA Approves $3.5 Million Hemophilia B Gene Therapy

NMPA has approved Ferinject in China for the treatment of iron deficiency or iron deficiency anemia. 

Ferinject Approved in China for the Treatment of Iron Deficiency in Adult Patients

Tzield (teplizumab-mzwv) injection is the first FDA-approved therapy designed to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older.

FDA Approves Injection Designed to Delay Onset of Type 1 Diabetes

Initially rejected in July 2021, XPHOZAH (tenapanor) won recommendations as both a monotherapy and combination treatment from FDA’s CRDAC meeting.

FDA Committee Recommends Ardelyx Kidney Disease Drug 

The new facility will allow ReiThera to consolidate its competitive position as a leading CDMO specialized in viral vector production. 

ReiThera Expands Viral Vector Production Capabilities with Opening of New Manufacturing Facility

The results of the mid-term election may reduce Congress’ ability to pass FDA-related legislation during its lame duck session. 

Major FDA Reform Unlikely in Closely Divided Congress

The UK MHRA has expanded the use of Cosentyx for use in pediatric arthritic conditions.

Regulatory Authority Actions