Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. FDA Guidance Addresses Real-World Evidence Data Standards The 21st Century Cures Act generated a good deal of excitement
As pharmaceutical science and innovation advance, breakthrough combination products frequently emerge that provide patients with therapeutics comprised of two or more constituents. Combination products can be either two or more active pharmaceutical molecules, combined to address different aspects of a health condition, or the combination
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Some Drugs May Require Reclassification to Devices On August 9, the FDA published a Federal Register notice requesting
The Camargo Blog has published a four-part blog series highlighting those designation programs available specifically for products with rare disease indications. This final installment will explain the criteria, timeline, and benefits of Humanitarian Use Device (HUD) designation. The HUD designation program is designed for medical
Throughout the life-cycle of a drug development program, sponsors are confronted with a range of key questions. They must decide on the correct… Regulatory pathway, FDA center, Key Opinion Leaders (KOLs), Target Product Profile (TPP) inclusions, Data to rely on, Studies to conduct, Indication and
With smartphones now ubiquitous, interest has increased in digital health solutions such as telemedicine platforms and apps used to track symptoms or medication usage. In recent months, the COVID-19 pandemic has only accelerated the adoption of these technologies. While many digital health products are unregulated,
A New Draft Guidance Provides In Vitro Diagnostic Device Requirements That May Impact Therapeutic Drug Trials Did you know that an assay used in a clinical trial designed to study an investigational drug may be considered an investigational In Vitro Diagnostic (IVD) Device, and