Quality Systems

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Articles

UK’s NICE has recommended Kapruvia as a treatment for adult patients with moderate-to-severe chronic kidney disease (CKD)-associated pruritus.

NICE Gives Nod to Kapruvia for Moderate-to-Severe CKD-Associated Pruritus

UK's NICE has recommended RINVOQ (upadacitinib) as a treatment option for adult patients in England and Wales with moderately to severely active Crohn’s disease. 

AbbVie Gains Access to UK Crohn’s Disease Market with NICE Recommendation

The two draft guidance documents provide recommendations for the approval of pediatric drugs, biologics, and vaccines under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act.

FDA Issues Guidance on Pediatric Drugs

The agency’s safety committee is reviewing hydroxyprogesterone medicines and issuing a reminder on safety issues regarding fluoroquinolone antibiotics.

EMA Issues Drug Safety Reminders

The agency has published guidance on good practices for securing the supply of medicines.

EMA Guidance Looks to Prevent Drug Shortages

The report outlines highlights from the agency’s medicines evaluations and milestones for 2022.

EMA Publishes Annual Report for 2022

In a brief, the Federal Trade Commission cited concerns about the acquisition resulting in an increased monopoly on Amgen’s newly acquired thyroid eye disease and chronic refractory gout treatments.

FTC Sues to Block Amgen’s $27.8 Billion Acquisition of Horizon Therapeutics

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

Congress have initiated a range of legislative proposals to further manage PBMs and the pharma market.

Pharma-PBM Battles Escalates on Capitol Hill

EC has granted marketing authorization to Chiesi Global Rare Diseases and Protalix BioTherapeutics for PRX-102 (pegunigalsidase alfa).

EC Authorizes Fabry Disease Treatment

The guidance is to provide information on compliance with applicable regulatory requirements and recommendations.

Regulatory Oversight and Compliance