Quality Systems

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

Articles

FDA once again is taking steps to facilitate the import of less costly prescription drugs.

FDA Moves Forward with State Drug Import Plans

Dupixent (dupilumab), developed by Regeneron Pharmaceuticals in partnership with Sanofi, has received FDA approval for a new indication—treating eosinophilic esophagitis, a chronic inflammatory disease. 

FDA Approves Sanofi’s and Regneron’s Dupixent to Treat Eosinophilic Esophagitis

A new initiative aims to speed the approval of and access to new drugs for young patients around the world, while limiting the number of children needed for testing in clinical trials.

New Guidelines Aim to Advance Pediatric Drug Development

AstraZeneca's recombinant COVID-19 vaccine, originally invented by the University of Oxford, has been approved as a third dose booster vaccine in the EU.

Vaxzevria Gains Approval in EU as a Third Dose COVID-19 Booster in Adults

EMA has recommended the marketing authorization of Xenpozyme (olipudase alfa) in the European Union. 

EMA Recommends Approval of Niemann-Pick Disease Types A/B and B Therapy

PTC Therapeutics has received a positive opinion from EMA for Upstaza for the treatment of AADC deficiency.

PTC Therapeutics Receives Positive Opinion for Upstaza

The final guidance addresses safety aspects of container and carton labeling design.

FDA Issues Labeling Guidance

The agency is asking drug manufacturers to ensure a strong supply chain by developing risk management plans.

FDA Stresses Risk Management Plans

FDA has approved Mounjaro (tirzepatide) injections as a treatment to improve blood sugar control in adults with type 2 diabetes.

FDA Approves Lilly’s Novel, Dual-Targeted Treatment for Type 2 Diabetes

Pfizer and BioNTech’s COVID-19 vaccine has been granted EUA for booster doses in children five through 11 years of age.

Regulatory Oversight and Compliance