by Katrina Rogers | Oct 11, 2018 | Uncategorized
Generic drugs offer a significant cost savings to patients and payors, and one reason they cost less is the path to FDA approval is shorter. Any proposed drug product that can be shown to be the same as a Reference Listed Drug (RLD) “with respect to active...
by Katrina Rogers | Oct 9, 2018 | Uncategorized
Represents a Shift in Thinking at the FDA The ECG app announced by Apple for the Series 4 Apple Watch has the potential to change how we think about and use our personal devices to improve our health and engage our healthcare providers. It also represents an important...
by Katrina Rogers | Oct 7, 2018 | Uncategorized
The FDA announced a two-day public workshop to discuss Patient Focused Drug Development on October 15-16th at their White Oak Campus in Maryland. The meeting is being held to gather public feedback to create patient-focused drug development guidance as required by the...
by Katrina Rogers | Oct 4, 2018 | Uncategorized
Keeping Track of FDA Requirements for Medical ProductsThe FDA is a complex organization with a wide range of responsibilities in human and animal health and safety. Even when you know which office or center is responsible for a topic, the range of instructions...
by Katrina Rogers | Oct 2, 2018 | Uncategorized
Readers may not be aware that the FDA has a number of approaches to gather feedback on regulations, programs, and other proposed changes to how the agency operates. One of the ways the agency obtains independent expert advice on scientific, technical, and policy...
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