Quality Systems

Articles

The final guidance provides recommendations for developing gene therapy products incorporating genome editing of human somatic cells.

FDA Give Guidance on Human Genome Editing in Gene Therapies

Feliza Mirasol is the science editor for 

Podcasts

In this episode of the Drug Solutions Podcast, industry experts give an overview of the biosimilars market and discuss factors affecting not only their manufacture, but their upstake in the market as well.

Drug Solutions Podcast: The Biosimilars Landscape

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

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

Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

MHRA has granted a Clinical Trial Authorization to PharmaKure for its oral combined drug for the treatment of mild cognitive impairment.

PharmaKure Gets Nod from MHRA to Trial Drug Targeting Amyloid Deposits

The final guidance document provides recommendations for designing a new registry or using an existing registry to support decisions regarding safety and effectiveness of a drug.

FDA Publishes Guidance on Real-Word Data

RoslinCT will manufacture Vertex Pharmaceuticals’ CRISPR-based gene therapy, Casgevy, recently approved for treating sickle cell disease and β thalassemia.

RoslinCT to Manufacture CRISPR-Based Gene Therapy Casgevy

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

Exagamglogene autotemcel seen as synechdoche.

Regulatory Filings and Submissions