October 23, 2015

ANVISA Selects New Director

Fernando Mendes Garcia Neto has been named a director of Brazil’s Agência Nacional de Vigilância Sanitária. His term will run through March 31, 2017. Neto fills the vacancy left by former director Jaime Cesar de Oliveria Moura, who resigned in April. Neto joins four other members, who vote on decisions for the agency, including newly installed Director President Jarbas Barbosa da Silva Júnior.

Danish MoH Seeks Director General

In an effort to reach a broader range of candidates, Denmark’s Ministry of Health has readvertised the position to helm the new Danish Medicines Agency. In August, the DoH announced it was establishing four new agencies so each could focus on its area of competence: the Danish Medicines Agency; Danish Health Authority; Danish Patient Safety Authority; and Danish Health Data Authority. One of the tasks will be pharmacovigilance and medical devices. The four agencies officially launched Oct. 8, and new websites for each will launch in January 2016.

Office of Women’s Health to Provide Update

The FDA has scheduled a Nov. 30 meeting, during which representatives from the Office of Women’s Health will discuss progress made on identified strategic priorities and initiatives. The meeting will take place at the AARP Cy Brickfield Center in Washington, D.C. The event is free, but attendees must preregister. Seating is limited to 25 participants. More information is available from an Oct. 19 Federal Register notice here: www.fdanews.com/102615-womens-health.pdf.

MDA, ASEAN Committee to Hold Seminar

The Malaysian Medical Device Authority has scheduled a Nov. 30 seminar to shine a light on potential hurdles industry might encounter while adhering to the Medical Device Act 737 of 2012, among other topics. Put on jointly with the Association of Southeast Asian Nations’ Consultative Committee on Standard and Quality – ASEAN Medical Device Committee, the seminar will touch on updates to the ASEAN Medical Device Directive and the MeDC@St modules for medical device registration. The seminar will be held just outside Kuala Lumpur. Interested parties must register by Nov. 9 via email to seminar@mdb.gov.my. Seating is limited to 100 people.

Allergan Completes AqueSys Buy

Dublin, Ireland-based Allergan has wrapped up its acquisition of AqueSys, an Orange County, Calif.-area device company focused on developing implants that reduce intraocular pressure associated with glaucoma. The all-cash transaction included a $300 million upfront payment and potential regulatory approval and commercialization milestones related to the lead product, XEN45, which has received a CE mark. It is in late-stage development in the U.S., with a fully enrolled IDE clinical trial. The company expects the FDA will give its nod to the implant by late 2016 or early 2017 through the 510(k) pathway.