In January Eye on FDA ran a look at the upcoming advisory committee meetings and their topics and it is time for an update.
It turns out that April is a ridiculously busy AdComm month, but there are some interesting meetings certainly.
- April 5 – Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee – the committee will be discussing the possible reclassification of Shortwave Diathermy devices, Class III, requiring premarket approval. Background information will be posted here.
- April 8 – Ophthalmic Devices Panel of the Medical Devices Advisory Committee – the committee will discuss and make recommendations on information regarding the premarket approval application for the Trulign Toric posterior chamber intraocular lens sponsred by Bausch and Lomb. Background information will be posted here.
- April 11 – Device Good Manufacturing Practice Advisory Committee – the committee will be meeting to discuss the potential effects of extreme weather and natural disasters on medical device manufacturing chain processes and marketed medical device safety and quality and how to optimize FDA’s current regulatory framework to address risk and vulnerabilities to manufacturing from extreme weather. Background material will be posted here.
- April 17 – Pulmonary-Allergy Drugs Advisory Committee – will meet to consider NDA for fluticasone fuoate and vilanterol dry powder inhaler (proposed tradename BREO ELLIPTA) sponsored by GSK for the long-term maintenance of airflow obstruction and for reducing exacerbations in patients with COPD. Background materials will be posted here.
- April 18 – Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee – to consider NDA for AVEED (testosterone undecanoate) intramuscular injection from Endo Pharmaceutical Solutions for the proposed indication of replacement therapy in adult males who have a deficiency or absence of testosterone. The safety discussion will focus on postmarketing reports of oil microembolism in the lungs and potential anaphylactic reactions. Background information will be posted here..
- April 25-26 – Clinical Chemistry and Clinical Toxicology Devices Panel – meeting on the 25th to discuss and make recommendations on the appropriate regulatory classification for diagnostic devices known as methotrexate enjyme immunoassays which are considered pre-Amendment devices in commercial distribution prior to May 28, 1976. FDA will be seeking safety and effectiveness input. A second session being held that day will look for recommendations on the appropriate classification for diagnostic devices known as phencyclidine (PCP) enzyme immunoassays and PCP radioimmunoassays, also Pre-Amendment devices and FDA is seeking safety and efficacy input. On the 26th it will be the same drill for isoniazid test strips, also Pre-Amendment. Background material will be made available here.
- May 2 – General and Plastic Surgery Devices Panel – the committee will discuss and make recommendations related to the premarket approval application for the Juv[eacute]derm Vouma XC sponsored by Allergan – a dermal filler indicated for deep implantation to restore lost volume. Background meeting information will be posted here.
- May 2 – Oncologic Drugs Advisory Committee – Two NDAs are up for consideration. In the morning the committee will discuss AVEO Pharmaceuticals NDA for tivozanib capsules with the proposed indication for the treatment of advanced renal cell carcinoma. In the afternoon Delcath Systems NDA for a drug/device combination with the proposed trade name Melblex Kit which is melphalan for injection to be used with the Delcath Hepatic Delivery System for the proposed treatment of patients with unresectable ocular melanoma that is matastatic to the liver. Background materials will be posted here.
- May 3 – Joint Meeting of the Medical Imaging Drugs Advisory Committee and the Oncologic Drugs Advisory Committee – meeting to discuss the safety and efficacy of currently approved leukocyte growth factors (LGFs) as potential treatments for radiation induced myelosupression associated with a radiological/nuclear incident. Background material will be posted here.
That’s it for now. I will update periodically.