Meetings, Workshops and Congressional Testimony:
Monday, 7/18 – Tuesday, 7/19 –
The FDA is holding a public workshop on Facilitating Antibacterial Drug Development for Patients with Unmet Need and Developing Antibacterial Drugs That Target a Single Species Media
. The FDA is interested in discussing the scientific challenges pertaining to such development programs, including enrollment challenges, clinical trial designs and trial population. This public workshop is intended to provide information for and gain perspective from health care providers, other U.S. government agencies, public health organizations, academic experts, and industry on various aspects of drug development for new antibacterial drugs for patients with unmet need and new antibacterial drugs that target a single species. The input from this public workshop will also help in developing topics for future discussion. The workshop is taking place beginning at 8:30 a.m., on both days, on the FDA’s White Oak Campus, Silver Spring, Maryland.
Tuesday, 7/19 –
The Dermatologic and Ophthalmic Drugs Advisory Committee
will meet to discuss biologics license application for brodalumab injection, a human monoclonal antibody, submitted by Valeant Pharmaceuticals Luxembourg S.à.r.l, proposed for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. The meeting will take place beginning at 8 a.m. on the FDA’s White Oak Campus, Silver Spring, Maryland.
Tuesday, 7/19 – The FDA and co-sponsor American Association for Cancer Research will hold a public workshop on Liquid Biopsies in Oncology Drug and Device Development. The workshop will provide a forum to discuss relevant scientific advances in the field of liquid biopsies in oncology and a regulatory environment that will support rapid translation of this emerging technology into improved patient care. The workshop aims to: 1) provide a state of the science overview of liquid biopsies in oncology; 2) discuss the use of tumor-derived cfDNA in drug development and clinical use, focusing on the treatment of lung cancer as a case study; 3) discuss current approaches to validation of in vitro diagnostic devices (or tests); and 4) discuss with diverse stakeholders ways to accelerate development of these technologies to advance cancer care. The workshop will take place beginning at 8:15 a.m. at the Walter E. Washington Convention Center, Washington, D.C.
Thursday, 7/21 – Friday, 7/22 –
The Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee
will discuss, make recommendations, and vote on information regarding a premarket approval application panel-track supplement for a proposed change in intended use of Dexcom, Inc.’s, Dexcom G5 Mobile Continuous Glucose Monitoring System (CGM) device so that, in addition to tracking and trending interstitial fluid glucose concentrations, patients can use the device as a replacement for their blood glucose meters and make treatment decisions based on the interstitial fluid glucose concentration reported by the CGM. The committee will also discuss and make recommendations on information regarding a premarket notification submission for the Alere Afinion HbA1c Dx point-of-care test system, sponsored by Alere Technologies AS. Alere Afinion HbA1c Dx is an in vitro diagnostic test for quantitative determination of glycated hemoglobin in human whole blood. This test is to be used as an aid in the diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes. The meeting will take place beginning at 8 a.m. at the Hilton Hotel, Gaithersburg, Maryland.
On the Web:
In Case You Missed It:
Thursday, 7/14 –
FDA Voice Blog: Charting a Path Forward on Food Safety, Nutrition and Animal Health
. At the FDA, we need to be prepared for the opportunities and challenges of today as well as those of tomorrow, and the FDA Foods and Veterinary Medicine Program’s new Strategic Plan for fiscal years 2016-2025 helps us to do just that.
Wednesday, 7/13 –
FDA Voice Blog: Registration of Food Facilities: A Key Link in the Safety Chain
. The FDA’s mission to protect consumers from unsafe food follows different paths. The seven rules that have been finalized since last fall to implement the 2011 FDA Food Safety Modernization Act will require food producers, importers, and transporters to take science- and risk-based actions to help prevent the contamination that leads to foodborne illness.
Tuesday, 7/12 –
News Release: FDA approves new medication for dry eye disease
. The FDA approved Xiidra (lifitegrast ophthalmic solution) for the treatment of signs and symptoms of dry eye disease, on Monday, July 11, 2016. Xiidra is the first medication in a new class of drugs, called lymphocyte function-associated antigen 1 (LFA-1) antagonist, approved by the FDA for dry eye disease.
Tuesday, 7/12 –
FDA Voice Blog: FDA Takes Action against Zika Virus
. Zika virus was first identified in 1947 in Uganda and for decades only sporadic cases and a few outbreaks were recognized in a number of locations, including parts of Africa, Asia, and the Pacific. Since 2015, the situation has changed dramatically, with 48 countries and territories reporting a first outbreak of Zika virus as of July 2016.
Monday, 7/11 –
News Release: FDA approves first MRI-guided focused ultrasound device to treat essential tremor
. The FDA approved the first focused ultrasound device to treat essential tremor in patients who have not responded to medication. ExAblate Neuro uses magnetic resonance (MR) images taken during the procedure to deliver focused ultrasound to destroy brain tissue in a tiny area thought to be responsible for causing tremors.