Regulatory Oversight and Compliance

WHO Calls for Increased Funding to Aid Yemen’s Health Crisis

February 27, 2023

WHO is appealing for US $392 million to reach 12.9 million people with essential health assistance in 2023.

Orchard Therapeutics to Reimburse Access to Libmeldy for MLD Patients in Sweden

February 27, 2023

Orchard Therapeutics has announced an agreement which will enable reimbursed access to Libmeldy for all eligible MLD patients in Sweden.

FDA Approves Sanofi Hemophilia Treatment

February 24, 2023

Sanofi’s once-weekly replacement therapy is FDA-approved for prevention and treatment of bleeding episodes in people with hemophilia A.

IRBs Need More Monitoring

February 23, 2023

GAO calls for more oversight of institutional review boards in clinical trials.

FDA Recommends Recall of Artificial Eye Ointment for Potential Bacterial Contamination

February 22, 2023

This warning is the second on top of a previous warning not to purchase or use EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears due to potential bacterial contamination.

FDA Approves First Treatment for Geographic Atrophy

February 22, 2023

Apellis Pharmaceuticals’ Syfovre is a pegcetacoplan injection intended for the treatment of geographic atrophy secondary to age-related macular degeneration.

Drug Solutions Podcast: Progressing Excipients Through Review

February 21, 2023

In this episode, Ana Ladino provides an update on the acceptance of a novel excipient onto CDER’s pilot program.

FDA Publishes New Product-Specific Guidelines for Generic Drug Development

February 17, 2023

Some noteworthy PSGs include dihydroergotamine mesylate nasal spray, glucagon nasal powder, afamelanotide subcutaneous implant, and triamcinolone acetonide injectable suspension.

FDA Announces BsUFA III Regulatory Science Program to Support Future Research

February 17, 2023

The intention of the FOA is to address diverse topics related to improving the efficiency of biosimilar product development and advancing the development of interchangeable products.

The COVID-19 Pandemic and Its Positive Impact on RNA Drug Development

February 15, 2023

The COVID-19 pandemic helped to showcase RNA molecules and their therapeutic potential. There were also lessons learned in terms of drug delivery, manufacturing, logistics, and storage.