In prior years, near the end of a calendar year, FDA would put up a schedule of Tentative Advisory Committee Meetings with tentative meeting dates scheduled for each Advisory Committee. This year, however, the calendar went up, but very few dates were committed to meetings.
The meetings were always listed by committee and by date. In February I provided an overview of upcoming advisory committees organized by subject matter and it turned out people seemed to like seeing what was coming in one spot sorted in that way, so here is an updated version. The February posting was notable because there were very few drug approvals but this round has some interesting drugs and devices being considered.
- RX to OTC Switch – On May 2, 2014, the Non-Prescription Drugs Advisory Committee will meet to consider the RX to OTC switch application of trade name SINGULAIR for the temporary relief of symptoms due to hay fever or other upper respiratory allergies: Nasal congestion, runny nose, itchy watery eyes, sneezing, itching of the nose.
- Safety and Efficacy Review – On April 24, 2014, the Neurological Devices Panel will meet to discuss the current knowledge about the safety and efficacy of aversive conditioning devices that are intended to deliver a noxious electrical stimulus to a patient to modify undesirable behavioral characteristics.
- PMA Approval Decision – On May 6, 2014, the Circulatory System Devices Panel will meet to consider an application for separate devices used together to enhance venous return to the heart and blood flow to vital organs during CPR to ultimately increase survival and neurologic outcome in patients suffering from cardiac arrest.
- Classification of Systems – The following day the committee will consider classification of long-term pulmonary support systems during the first session and in the second session will consider classification of “More-than-Minimally Manipulated Allograft Heatt Valves”.
- Consumer Updates – On May 5-6 the Risk Communication Advisory Committee will meet to discuss how FDA can evaluate whether its Consumer Updates are effectively reaching the target population and increasing understanding of key risk messages and whether they are having the intended effect.
- Guidance Documents – On May 13, the Ophthalmic Devices Panel will meet to discuss FDA guidance documents related to contact lenses and accessories.
- PMA Approval Consideration – On June 17, 2014, the Gastroenterology and Urology Devices Panel will meet to discuss consideration of a PMA for an implantable device for the proposed indication for use in weight reduction in patients with obesity as the agency considers a ban on such devices.
- NDA Approval Consideration - On June 24, 2014, the Oncology Drugs Advisory Committee will be meeting to consider an NDA submitted by AstraZeneca Pharmaceuticals for olaparib for the proposed indication as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed ovarian (including fallopian tube or primary peritoneal) with BRCA mutation who are in response (complete or partial response) to platinum-based chemotherapy.
- NDA Approval Consideration – The Anesthetic and Analgesic Drugs Advisory Committee will meet today to consider an NDA from QRxPharma for MOXDUO (morphine sulphate and oxycodone hydrochloride) for the proposed indication of management of moderate to severe pain where use of an opioid analgesic is appropriate, representing the first drug combination utilizing two immediate release opioids.