Uncategorized

Legislative Update — Week of March 18, 2024

As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations that could impact your business. Source: Drug Industry Daily

Read More

Indian Chemotherapy Drug Manufacturer Dinged With 483

Sterile drug manufacturer Eugia SEZ Private Limited’s February FDA inspection resulted in a Form 483 laden with examples of the company failing to follow procedures to prevent microbiological contamination of its drug products among seven observations of other lapses. Source: Drug Industry Daily

Read More

FDA Panel Endorses Geron’s Anemia Drug for Group of Blood Cancers

In a 12 to 2 vote Thursday, an FDA advisory committee gave a thumbs up to Geron Corporation’s imetelstat for treating transfusion-dependent (TD) anemia in adults with low-to-intermediate-1 risk myelodysplastic syndromes (LR-MDS), who are ineligible or don’t respond to erythropoiesis-stimulating agents (ESAs). Source: Drug Industry Daily

Read More

Regulatory Update — Week of March 11, 2024

Over the past week, the FDA issued final guidance on assessing COVID-19 symptoms in adult and adolescent clinical trial subjects. Draft guidances were issued covering drug development for early onset Alzheimer’s disease, labeling changes for nonprescription drug NDAs and ANDAs, updates for the premarket cybersecurity guidance, E2D(R1) postapproval safety data, thermal effects of tissue heating…

Read More

First Treatment for NASH Gets FDA Approval

The FDA’s approval on Thursday of Madrigal Pharmaceutical’s Rezdiffra (resmetirom) is the first for the treatment of adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis). Source: Drug Industry Daily

Read More