Topic

Articles

The company issued the recall because of a package mislabeling problem.

Azurity Recalls Zenzedi

Feliza Mirasol is the science editor for 

Takeda has received FDA approval for HYQVIA, a subcutaneous immunoglobulin for the maintenance treatment of chronic inflammatory demyelinating polyneuropathy.

Takeda’s Subcutaneous Immunoglobulin Receives FDA Approval for Maintenance Therapy of Rare Neuromuscular Disorder

The agency recommended 77 drugs for marketing authorization in 2023, including 39 new APIs.

EMA Looks Back at Medicines Approved in 2023 

FDA’s Center for Drug Evaluation and Research released its report on new drugs approved in 2023.

CDER Approved 55 Novel Drugs in 2023

The agency is reviewing data on secondary malignancies related to T-cells for approved CAR T-cell medicines.

EMA Starts Safety Review of CAR T-Cell Medicines

The European Medicines Agency safety committee says there is a potential risk of neurodevelopment disorders in children born to men treated with valproate. 

Precautionary Measures Recommended in Use of Valproate Medicines

Ashley Boam, MSBE, is the Director of the Office of Policy for Pharmaceutical Quality in FDA’s Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research. 

Theresa Mullin, PhD serves as CDER’s Associate Director for Strategic Initiatives and leads CDER’s International Program in FDA.

Harmonization of global regulations fosters innovation and ensures quality medicines.

The Global Regulatory Village

Adam C. Fisher, Phd, is Director of Science Staff, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, FDA.

FDA is anticipating how AI may advance manufacturing and improve supply chain security.

Artificial Intelligence in Pharmaceutical Manufacturing

Barbara Scott is a Master Reviewer at FDA Center for Drug Evaluation and Research/Office of Pharmaceutical Quality/Office of New Drug Products/ Division of Lifecycle Active Pharmaceutical Ingredients, Barbara.Scott@fda.hhs.gov.

David Green is a Senior Pharmaceutical Quality Assessor at FDA Center for Drug Evaluation and Research/Office of Pharmaceutical Quality/Office of New Drug Products/ Division of Lifecycle Active Pharmaceutical Ingredients.

Marlene Kim is a Chemist at FDA Office of the Commissioner/Office of Digital Transformation/Office of Data, Analytics, and Research/Health Informatics Staff.

Naomi Kruhlak is Scientific Lead, Computational Toxicology Consultation Service at FDA Center for Drug Evaluation and Research/Office of Translational Sciences/Office of Clinical Pharmacology/ Division of Applied Regulatory Science.

Tyler Peryea is a Chemist at FDA Office of the Commissioner/Office of Digital Transformation/Office of Data, Analytics, and Research/Health Informatics Staff.

David Skanchy was the Division Director (retired) at FDA Center for Drug Evaluation and Research/Office of Pharmaceutical Quality/Office of New Drug Products/ Division of Lifecycle Active Pharmaceutical Ingredients.

The SD File format offers benefits for KASA and cheminformatics to support regulatory submissions.

Master File Submission of Structures

Kevin O’Donnell is Market Compliance Manager at Ireland’s Health Products Regulatory Authority.

Cliff Campbell is senior consultant at KPC.

Quality Quartets may be used to achieve knowledge-driven, risk-based approaches to commissioning and qualification that are consistent with ICH Q9(R1) principles.

Quality Systems