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…


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…

Which Regulatory Path Should I Choose for FDA Combination Products?

With FDA Combination Products on the Rise, a Common Question is, “Which regulatory path should I choose?”

What is a Combination Product? In a world in which we are continuously challenged to operate more efficiently and immersed in rapid technological advances, it should come as no surprise that one of today’s fastest growing medical product segments are combination products. To be considered a combination product by FDA, there must be two or…

Taking a drug holiday

Drug Holidays – Temporary Suspension of Therapy; Drug Labeling Consultant’s Perspective

Drug holidays are not often described in the U.S. professional labeling of prescription drug products. However, they are routinely employed across various classes of drugs as well as a variety of patient populations. As the name implies, a drug holiday is the temporary suspension of active therapy[1], and is usually enacted to avoid adverse events…


FDA Issues Final Hatch-Waxman Rule Implementing Certain Provisions of the 2003 Medicare Modernization Act

Following is an excerpt from the Executive Summary (Click here for the Final Rule; 81 FR 69580) “Title XI of the MMA addressed two key concerns identified in a Federal Trade Commission (FTC) report on anticompetitive strategies that may delay access to generic drugs by: (1) Limiting the availability of 30-month stays of approval on…