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The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs

The FDA Law Blog

Karst The FDA Reduction-in-Force (Termination)or RIF(T)announced last week has resulted in countless stories in the press and on personal LinkedIn accounts from those RIFd. As folks steeped in the world of generic drugs And Hatch-Waxman know, theres a lot that happens before FDA can take action on an ANDA.

FDA
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Fixing pulse oximeters requires federal might and possible legal action, researchers say

STAT

Work by device manufacturers to improve the performance of pulse oximeters on people with darker skin has progressed little since the Food and Drug Administration asked manufacturers in 2013 to voluntarily test the devices on more diverse skin tones, according to a study published Monday in JAMA.

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Glipizide Increases Cardiovascular Risk Compared to DPP4 Inhibitors in T2D

Drug Topics

The comparative effectiveness study included 48165 patients with T2D and moderate cardiovascular risk who were treated at 1 of 10 health systems in the United States between January 2013 and January 2023.

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Pharmacists Bridge the Gaps in Care Transitions

Pharmacy Times

February 2013. BMC Health Serv Res. 2024;24(1):576. doi:10.1186/s12913-024-11047-3 5. American Society of Health-System Pharmacists and American Pharmacists Association. ASHP-APhA Medication Management in Care Transitions Best Practices. Accessed July 7, 2025. Tasseff N, Axtell S, Nixon B. Subscribe Now!

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DSCSA Compliance: The Time is Now

Pharmaceutical Commerce

Stakeholders are aware that this federal law—enforced by the FDA and originally enacted in 2013 as a way to help bolster security and traceability of products passing through the pharma supply chain—has seen its share of delays and exemptions over the years.

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Lumateperone Submits Application for Schizophrenia Indication to FDA for Supplemental New Drug

Pharmacy Times

A recent supplemental new drug application (sNDA) submitted to the FDA seeks to expand lumapeterone’s approval based on compelling relapse prevention data. A recent supplemental new drug application (sNDA) submitted to the FDA seeks to expand lumapeterone’s approval based on compelling relapse prevention data. 1-3 REFERENCES 1.

FDA
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The MEK effect on cancer — a slow and steady approach to drug resistance

PharmaVoice

The FDA approved the first MEK inhibitor, a melanoma drug from Novartis, in 2013. The broad mechanism allows them to target multiple tumor types, including those with RAS mutations, which are common in melanoma, pancreatic, colorectal and lung cancers.