by Katrina Rogers | Sep 18, 2018 | Uncategorized
I was surprised this month to find Methicillin-Resistant Staphylococcus Aureus (better known as MRSA) on a clinical admissions form for patients to list existing conditions prior to treatment. It was right there alongside more commonly observed conditions like high...
by Katrina Rogers | Sep 17, 2018 | Uncategorized
In order to provide the necessary data for an IND, you’ll need to apply some analytical chemistry to create methods for measuring your drug. For efficacy and exposure, you’ll need methods to measure the presence and concentration over time in in vitro samples (such as...
by Katrina Rogers | Sep 13, 2018 | Uncategorized
The 21st Century Cures Act of 2016 deregulated certain medical software, including: Software that supports administrative functions like billing or reimbursement Software that encourages a healthy lifestyle, Software that serves as electronic patient...
by Katrina Rogers | Sep 11, 2018 | Uncategorized
In a blog post last June, CDER director Janet Woodcock announced her proposed changes to the Center’s regulatory and review process for new drugs. These changes include:Enhancing recruitment and career development of a diverse group of scientistsEstablishing,...
by Katrina Rogers | Sep 9, 2018 | Uncategorized
Health-related mobile apps, particularly those that collect, create, or share consumer information, are regulated under a variety of federal laws, including the FTC Act, the FTC’s Health Breach Notification Rule, the Health Insurance Portability and Accountability Act...
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