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New Drug Designations - July 2023

New Drug Designations – July 2023

Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, the EU, China, and Korea. This month’s report includes 7 biological drugs, 10 small molecules, 8 cell and gene therapies, 1 radiopharmaceutical, 2 microbiota and 1 diagnostic test  MyoPax’ Satori-01, focused on repairing the Exstrophy-Epispadias Complex sphincter…

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FDA Launches a Pilot Program to Regulate the Safety Standards Associated with In vitro Diagnostic Tests to Identify Cancer Biomarkers

In a landmark decision, FDA on June 20th, 2023 launched a new pilot program to mitigate the risks involved with certain Laboratory Developed Tests (LDTs) used to develop certain oncology products. It is an important initiative by FDA to address the safety standards associated with unregulated or poorly performing in vitro diagnostic tests. With an…

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