Combination products are medical products composed of 2 or more different types of individual medical products; for example, a drug plus dosing device (think of asthma inhalers or prefilled syringes) or a drug plus the solution needed to reconstitute it for dosing...
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Microengineered Organ Systems for Toxicology Predictions
CDER researchers are working on approaches to predict drug effects on human systems before clinical trials start. My earlier post on Physiological Based Pharmacokinetic Modeling discusses one such approach used for predicting human systemic exposure following dose...
What Are All These Device Review and Approval Pathways? Part 10
The Breakthrough Devices ProgramDevices and device-led combination may be eligible for enhanced access to reviewers and priority review through the Breakthrough Devices program if they meet the program criteria:The device provides for more effective treatment or...
What Are All These Device Review and Approval Pathways? Part 9B
Clinical Studies for Significant and Nonsignificant Risk Medical DevicesAn IDE is required for all medical devices that are considered significant risk devices. Guidance is available for sponsors and IRBs on what constitutes a significant risk device. Under the...
What Are All These Device Review and Approval Pathways? Part 9A
Investigational Device ExemptionMost PMAs and a small percentage of 510(k)s require clinical data to support the application. Good Clinical Practice (GCP) regulations apply to any clinical study of a device, whether that devices poses a significant risk (SR) or not...
Haven is the New Name of the ABC Healthcare Startup
If you share my interests, you have been following the news about the Amazon/Berkshire Hathaway/JP Morgan & Chase (often referred to as ABC) collaboration to find ways to change the experience of health care for patients, providers, and companies. The company has...
Physiologically Based Pharmacokinetic Modeling
In Drug Development CDER published a survey article in February 2019 giving a capsule description of the application of Physiologically Based Pharmacokinetic Modeling (PBPM) in modern drug development. The article presents one of the nicest visuals for PBPM I’ve seen...
Clinical Immunogenicity Testing of Therapeutic Proteins
Guidance for Development of Anti-Drug Antibody TestsA fairly common event with therapeutic proteins is the generation of immune responses to the therapy or related proteins by the patient’s immune system. These immune responses have the potential to affect product...