Drugs

FDA Moving on with Device Single Audit Program

FDA said 12/17/15 that it will participate in the operational phase of the Medical Device Single Audit Program (MDSAP) starting 1/1/17. It currently is part of the MDSAP pilot that runs for the rest of this year. Attorneys John Wyand and Sarah Stec (Squire Patton Boggs) write in an online post that MDSAP was created by the International Medical Device Regulators Forum, a consortium of nine medical device regulators worldwide, in an attempt to streamline inspection operations. Five of the regulators are participating in the pilot—FDA, Health Canada, Japan, Brazil, and Australia.

The attorneys say the program provides for medical device manufacturers to undergo one scheduled audit that covers the quality management system requirements for all five jurisdictions in the pilot, rather than having many inspections from different regulators.

“The MDSAP program presents both pros and cons to the medical device industry,” they write, “and an establishment should carefully weigh its options before submitting to an MDSAP audit. First, combining audits is a clear money- and resource-saver for medical device manufacturers, especially larger ones and ones that sell products around the world and that may be subject to lengthy inspections as a result of their size and operations. Second, the MDSAP audits are scheduled months in advance, allowing manufacturers time to set aside the time and resources necessary to successfully go through the audit. However, the MDSAP’s requirement to include all jurisdictions in the audit in which the establishment’s products are sold brings questions of what exactly the different regulators will look at in the reports, even for those manufacturers who do not currently have marketing approval in their particular country.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome