Quality Systems

Articles

CDER Director Patrizia Cavazzoni and CBER Director Peter Marks provided an update on the rare disease innovation hub in a new FDA Voices blog post.

FDA Rare Disease Innovation Moves Forward

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

The treatment for ATTR in certain adults with polyneuropathy had just been recommended for approval across the European Union and had gained regulatory approval in the United States at the end of 2023.

AstraZeneca’s Wainzua Gains Another Approval in England and Wales

A new laboratory will be built in Oss, while additional capacity and capabilities will be added to the Bioanalytical Center of Excellence in Assen.

Ardena Expands Bioanalytical Services in the Netherlands

Vyalev, also known as Produodopa, has been approved in 35 countries, with more than 4200 patients having started treatment.

FDA Approves AbbVie Therapy for Adults with Advanced Parkinson’s Disease

Aloka Srinivasan, PhD, is Principal and Managing Partner, Raaha LLC.

This article presents an overview of FDA’s recent update to the guidance document, Control of Nitrosamine Impurities in Human Drugs.

What Does the FDA's Recent Update of the Nitrosamine Guidance Convey?

Pfizer’s bivalent RSV prefusion F vaccine has been approved to prevent lower respiratory tract disease resulting from the respiratory syncytial virus in adults 18 to 59 years of age who are at increased risk.


FDA Approves RSV Vaccine

As many as 30% of people living with severe hemophilia A develop inhibitors such as TFPI, which can be produced by the body’s immune response to clotting factors in replacement therapy, often limiting the effectiveness of that therapy.

CHMP Gives Positive Opinion to Novo Nordisk Hemophilia Treatment

Wainzua had been previously approved for use by patients with ATTRv-PN in the United States, under the brand name Wainua.

AstraZeneca’s Polyneuropathy Treatment Recommended for EU Approval

Videos

Redica Systems has been assisting pharmaceutical companies in determining GMP quality risks at their manufacturing sites, and with AI, it has a relatively new addition to its toolbox.

AAPS PharmSci 360 2024: How AI is Helping to Ensure Companies’ GMP Health

The agency’s CHMP recommended drugs to treatments for hemophilia, two biosimilars for psoriasis, and two flu vaccines at their October meeting.

Regulatory Oversight and Compliance