Regulatory Oversight and Compliance

The Dislocation of Progress

December 02, 2023

Pharmaceuticals are entering a transition into a far more complex era of patient therapies, and patient segmentation.

New Medicines, Markets, and Manufacture: CRISPR for Sickle Cell Disease and β-thalassemia

November 30, 2023

Exagamglogene autotemcel seen as synechdoche.

Consent Decrees Entered Against Utah Supplement Manufacturer and Distributors

November 20, 2023

Consent decrees were issued against Evig LLC, of St. George, Utah, and Premium Production LLC, of St. George, Utah, for unapproved dietary supplements.

Consent Decree Entered Against Arizona Company

November 20, 2023

The US District Court for the District of Arizona entered into consent decree against Smart Women’s Choice and its CEO to stop the company from distributing unapproved contraceptive drugs.

FDA Approves First Recombinant Treatment for Rare Blood Clotting Disorder

November 14, 2023

Adzynma provides a replacement for low levels of the ADAMTS13 enzyme in patients with congenital thrombotic thrombocytopenic purpura.

EMA Recommends Rare Blood Cancer Treatment and Seven Other Medicines

November 13, 2023

Recommended medicines include treatments for generalized myasthenia gravis, glioma, neovascular age-related macular degeneration, and more.

Europe Publishes Electronic Product Information for Selected Medicines

November 09, 2023

Electronic product information for selected human medicines that have been harmonized across the European Union have been published for the first time.

FDA Publishes Guidance on Container Closure Systems for COVID-19

November 09, 2023

The document includes recommendations for the reporting and implementation of changes to container closure system components.

Key E&L Issues to Consider During Formulation (AAPS PharmSci 360)

November 03, 2023

Dujuan Lu, PhD, global leader—E&L, SGS Health Sciences, recommends some key issues that pharma manufacturers should consider when formulating products that require a medical device.

New Biologic Treatment for Hidradenitis Suppurativa Receives FDA Approval

November 03, 2023

This is the second biologic approved to treat HS, a painful and reoccurring skin disease.