Quality Systems

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

Articles

FDA keeps its user fees but fails to gain important reforms.

FDA User Fees Reauthorized

Marina Necdina has more than 10 years of exerience as a bench scientist specializing in the areas of biochemistry, cell biology, and drug manufacturing.

New medications show exciting outcomes for weight loss.

Are Obesity Drugs the Next Blockbusters? 

AstraZeneca’s Imjudo (tremelimumab) was approved by FDA in combination with Imfinzi (durvalumab) for treating unresectable liver cancer.

FDA Approves AstraZeneca’s Imjudo for Combination Liver Cancer Treatment

An advisory committee’s vote to remove Makena from the market illustrates how difficult it is for regulators to ensure that such drugs document safety and effectiveness in a timely manner.

Pressure Mounts for FDA to Reform Accelerated Approval Program

CBER maps modernization plan to handle surge in research and applications. 

FDA Expands Oversight of Cell and Gene Therapies

FDA has approved Relyrio as a once-to-twice daily treatment for patients with ALS.

FDA Approves Amylyx Pharmaceuticals Novel ALS Treatment

Legislative leaders are looking to approve a bare-bones measure to fund FDA operations as part of a short-term government funding bill. 

Congress Slated to Reauthorize User Fees Without FDA “Improvements” 

The patent applications are for programs concerning lupus, idiopathic pulmonary fibrosis, and chronic kidney disease.

Aria Pharmaceuticals Files Applications for Six Provisional Patents

Manuela Gottschall is Head of Risk and Project Management, Global Quality at Roche.

Marie Schommer is Quality Manager at Roche Diagnostics GmbH.

Federico Colombari is Quality Risk Management Specialist at Roche.

A Post Approval Change (PAC) to replace identity (ID) testing of incoming liquid drug substance with ID by visual inspection is considered a low risk provided questioned listed in this example have been answered favorably. In that case the PAC can be downgraded from a prior approval to a notification to health authorities, and managed in the PQS with immediate implementation effect.

Industry 1VQ Solutions: Replace Identity (ID) Testing of Incoming Liquid Drug Substance with ID by Visual Verification 

Marie-Claire Beckers is global subject matter expert for QC Materials and Samples Management at GSK Vaccines.

Delphine Collete is global subject matter expert for QC Materials Management at GSK Vaccines.

Julie Barthuet is head Regulatory CMC&D Vaccines at Sanofi Vaccines.

Thierry Gastineau is Global Head of Quality Advocacy, Culture, & Innovation at Sanofi Vaccines.

Change of lot or extension of reference standard shelf-life is considered low
risk and should be downgraded from prior-approval to being managed in the Pharmaceutical Quality System (PQS) only based on a science and risk-based approach.

Regulatory Filings and Submissions