Regulatory Oversight and Compliance

EMA Updates Guidance on Risk Management Plans for COVID-19 Vaccines

February 16, 2022

Guidance published during the pandemic has been updated to include content requirements for summary safety reports.

EMA Investigating Reports of Menstrual Irregularities with COVID-19 Vaccines

February 16, 2022

The agency’s safety committee is assessing reported cases of period irregularities associated with Comirnaty and Spikevax mRNA vaccines.

EMA Reviews Safety of Janus Kinase Inhibitors to Treat Inflammatory Disorders

February 16, 2022

The agency’s safety committee is reviewing the use of Janus kinase inhibitors to treat inflammatory disorders because of the potential for major cardiovascular problems.

New Medicines Recommendations Up in 2021, EMA States

February 16, 2022

The agency recommended 53 new active substances in 2021, up 35% from 2020.

Thermo Fisher Scientific Unveils New CGT Services

February 16, 2022

Thermo Fisher Scientific's solution for cell and gene therapies involves a combination of cold chain logistics, serialization compliance, and distribution

The Next Frontier in Pharmaceutical Outsourcing

February 15, 2022

While companies today outsource numerous processes, from early development through to manufacturing, there are still many opportunities to realize the full potential of outsourcing services.

Novavax COVID-19 Vaccine Gaining Regulatory Ground

February 11, 2022

Novavax’s COVID-19 vaccine has received conditional marketing authorization from MHRA and provisional approval from Medsafe.

EMA Considers Adolescent Booster-Dose Application for Comirnaty

February 11, 2022

EMA has started its evaluation of an application for the use of a booster dose of Comirnaty in adolescents aged 12–15 years.

EMA Initiates DARWIN EU Coordination Centre

February 11, 2022

EMA has started the establishment of its Data Analysis and Real World Interrogation Network (DARWIN EU) Coordination Centre.

FDA Approves Treatment for Rare Autoimmune Disorder

February 10, 2022

FDA has approved sutimlimab-jome as a treatment for hemolysis in individuals with CAD.