Regulatory Oversight and Compliance

White House Promotes US Drug Manufacturing to Secure Access to Vital Medicines

July 02, 2021

HHS is tasked with establishing a public-private consortium for advanced domestic pharmaceutical production.

Identifying Promising COVID-19 Therapies

July 02, 2021

Five therapeutic candidates for the treatment of COVID-19 are identified as promising by the European Commission.

The Value of FDA 483s and Warning Letters

July 02, 2021

Regulatory inspection reports can be a valuable resource for quality management, according to Siegfried Schmitt, vice president, Technical at Parexel.

Airborne Particle Counter

July 02, 2021

The Lasair Pro Airborne Particle Counter from Particle Measuring Systems is designed to meet data Integrity and regulatory requirements.

The Necessity of Prioritizing Cleaning Validation

July 01, 2021

With COVID-19 vaccine facilities receiving recent citations, it is evident that failure to meet cleaning and sanitization requirements puts patients, facilities, and operators at risk.

CHMP Recommends EU Approval of Bimekizumab for Plaque Psoriasis

June 29, 2021

EMA's CHMP has adopted a positive opinion recommending the approval of UCB’s bimekizumab (Bimzelx) for the treatment of plaque psoriasis.

Otsuka Pharmaceuticals Europe Files MAA with EMA for Voclosporin

June 29, 2021

Otsuka Pharmaceuticals Europe has filed an initial marketing authorization application to the European Medicines Agency for voclosporin.

FDA Adds Warning to mRNA Vaccine Fact Sheets

June 28, 2021

Reports of myocarditis and pericarditis following Pfizer-BioNTech and Moderna vaccinations prompts warnings.

Tackling Counterfeit Medicines

June 28, 2021

Pharmaceutical Technology discussed the potential increased risk of counterfeit medicines in the UK post-Brexit and how blockchain could be a useful tool to tackle the issue.

Amgen’s Aimovig Approved in Japan for Treating Migraine

June 25, 2021

Amgen’s Aimovig has become the first and only approved treatment in Japan for treating migraine attacks in adults by blocking the CGRP-R.