Regulatory Oversight and Compliance

Pfizer Issues Voluntary Nationwide Recall of Lots of Accupril

April 25, 2022

Pfizer has issued a voluntary nationwide recall of lots of Accupril due to N-nitroso-quinapril content.

EMA Recommends EU Conditional Approval of Roche’s Mosunetuzumab

April 25, 2022

EMA is recommending EU conditional approval of Roche’s potential first-in-class bispecific antibody mosunetuzumab for people with relapsed or refractory follicular lymphoma.

Novo Nordisk Announces Positive Scientific Opinion from EMA on Human Insulin

April 25, 2022

EMA has granted Novo Nordisk a positive scientific opinion on human insulin with more flexible storage without refrigeration.

FDA Requesting Comment on Pharmaceutical Quality/Chemistry Manufacturing and Controls Data Exchange

April 22, 2022

FDA is requesting comment on draft document “Pharmaceutical Quality/Chemistry Manufacturing and Controls Data Exchange.”

FDA Approves Kite’s CAR T-Cell Therapy Manufacturing Facility in Maryland

April 22, 2022

FDA has approved commercial production at Kite’s new CAR T-cell therapy manufacturing facility in Frederick, Maryland.

Clinical Trial Diversity Advances in Regulatory Agenda

April 20, 2022

New guidance from FDA and legislation from Congress promote clinical trial diversity.

Swissmedic Grants Conditional Marketing Authorization for Novavax COVID-19 Vaccine

April 13, 2022

Swissmedic grants conditional marketing authorization for Novavax COVID-19 vaccine for individuals aged 18 years or older in Switzerland.

FDA Revives Initiative to Identify and Reward Quality Drug Operations

April 12, 2022

FDA is reviving efforts to establish a Quality Management Maturity program.

The Role of Technology in CAPAs

April 12, 2022

Pharmaceutical Technology asked Jeff Elton, PhD, CEO of ConcertAI, about the role technology plays in performing CAPAs.

Orchard Therapeutics Announces Reimbursement Agreement for Libmeldy

April 12, 2022

Orchard Therapeutics announces reimbursement agreement, which will make Libmeldy available for all eligible MLD patients in Italy.