Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products
The U.S. Food and Drug Administration (FDA) plays a critical role in regulating medical devices to ensure their safety and effectiveness. One area of…
Read more →Container Closure System and Component Changes: Glass Vials and Stoppers
The U.S. Food and Drug Administration (FDA) has released guidance on Clinical Decision Support (CDS) software, which aims to clarify regulatory oversight and ensure…
Read more →Application User Fees for Combination Products
The U.S. Food and Drug Administration (FDA) provides detailed guidelines for the use of Investigational Device Exemptions (IDE) in early feasibility studies (EFS) to…
Read more →Drugs for the Treatment of Partial Onset Seizures: Extrapolation of Efficacy from Adults to Pediatric Patients 1 Month of Age and Older
The U.S. Food and Drug Administration (FDA) has issued guidance titled “Drugs for the Treatment of Partial Onset Seizures: Extrapolation of Efficacy from Adults…
Read more →Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder
The U.S. Food and Drug Administration (FDA) has released a guidance document titled “Clinical Considerations for Studies of Devices Intended to Treat Opioid Use…
Read more →Use of Circulating Tumor Deoxyribonucleic Acid for Early-Stage Solid Tumor Drug Development; Guidance for Industry; Availability
In November 2024, the U.S. Food and Drug Administration (FDA) issued a guidance document titled “Use of Circulating Tumor DNA for Curative-Intent Solid Tumor…
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