While this FDA web upgrade is not breaking news (it first appeared in July 2016), it is worth knowing about. Previously hard to find documents, many requiring purchase from outside vendors or long FOIA wait times, may now be found instantaneously and free of charge. Included (among others) are EIRs, 483s, 483 responses, etc. To…
Recently, GoodRx, Inc. reported that “Several times a year, GoodRx creates a list of the most-dispensed prescriptions in the U.S. To form our list, we look at a sample of claims as reported by pharmacies across the country. We combine prescriptions for brands and generics; we also display the GoodRx Fair Price for the most…
On November 8, 2016, FDA issued Medical Device Reporting for Manufacturers Guidance for Industry and Food and Drug Administration Staff noting that the draft was issued on July 9, 2013 and that the new guidance supersedes Medical Device Reporting for Manufacturers dated March 1997. According to the Notice of Availability (81 FR 78603) “The draft…
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…
On November 8, 2016, FDA announced a final rule (81 FR 78500) amending citizen petition regulations (21 CFR 10). The new rule is meant to ensure the agency does not delay the approval of a pending ANDA, 505(b)(2) or biosimilar application filed under section 351(k) of the PHS Act, unless that delay is necessary to…
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…
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…