FDA Publishes Draft Guidance on Format and Content of Physiologically-Based Pharmacokinetic Analyses

According to the Background, “This guidance outlines the recommended format and content for a sponsor to submit physiologically based pharmacokinetic (PBPK) analyses to the FDA to support applications including investigational new drug (INDs) applications, new drug applications (NDAs), biologics license applications (BLAs), or abbreviated new drug applications (ANDAs). To enable efficient and consistent review, the…

Details

FDA Reports “Progress & Potential” With Regard to Combination Products

According to FDA Commissioner Robert M. Califf, M.D. and Nina L. Hunter, Ph.D., FDA’s Associate Director for Science Policy in the Office of Medical Products and Tobacco, “About a year ago, we shared with you our Combination Product Review, Intercenter Consult Process Study Report, which was developed by FDA’s Office of Planning. The report’s findings were…

Details

President Signs 21st Century Cures Act Into Law, FDA Commissioner Comments

The Washington Post recently reported that “The bill provides for $4.8 billion in new funding for the National Institutes of Health; of that, $1.8 billion is reserved for the “cancer moonshot” launched by Vice President Biden to accelerate research in that field. Another $1.6 billion is earmarked for brain diseases including Alzheimer’s. Also included are…

Details

Senator Offers President-Elect Help Bringing Drug Prices Down

FiercePharma recently reported “Trump wants to battle high drug prices? Let’s work together, hike-fighting senator says.”  In the story, Sen. Amy Klobuchar (D-Minnesota), has a message for President-elect Donald Trump: “Let’s bring drug prices down together… In a new op-ed for USA Today, Sen. Klobuchar outlined several tactics that, if implemented, would reduce prices in the U.S., she…

Details

FDA Launches Website to Help Sponsors and Innovators Develop Neurological Medical Devices

As one of the partners in the White House “Brain Research through Advancing Innovative Neurotechnologies Initiative” (BRAIN), FDA is “working to enhance the transparency and predictability of the regulatory process for developers and innovators of neurological medical devices.” Recently, FDA announced a new website “intended to assist neurological device developers, sponsors and innovators with navigating…

Details

FDA Encourages Development of Abuse-Deterrent (AD) Generic Opioids

In advance of FDA’s Public Meeting on Pre-Market Evaluation of Abuse-Deterrent Properties of Opioid Drug Products (October 31 – November 1, 2016), FDA Voice published Key Facts about Abuse-Deterrent Opioids, by Douglas C. Throckmorton, M.D. In his article, Throckmorton reminds us that “It’s important to recognize that FDA refers to these drugs as ‘abuse-deterrent’ not…

Details