FDA News & Notes – Week of June 27, 2016
Science, public health, and regulatory highlights from the U.S. Food and Drug Administration. Information in this document is designed for credentialed journalists. Release dates and times for items are current as of June 27, 2016. Times listed are local time.
FDA News & Notes does not contain any regulatory or enforcement actions due to legal limitations.
Events and Speeches for the Commissioner and FDA Leadership:
Tuesday, 6/28 –
FDA Commissioner Robert Califf, M.D., will participate two panel discussions at the 2016 DIA Annual Meeting
. The first panel, with global regulatory leaders, will focus on International Regulatory Convergence, Collaboration and Cooperation. The second panel will focus on How Big Data and Artificial Intelligence Change our Regulatory Environment. The meeting will take place in Philadelphia, Pennsylvania.
Press Office Contact: Jason Young, 301-796-9187, firstname.lastname@example.org
Meetings, Workshops and Congressional Testimony:
Tuesday, 6/28 –
The Endocrinologic and Metabolic Drugs Advisory Committee
will meet to discuss supplemental new drug application 204629 for empagliflozin (JARDIANCE) tablets and supplemental new drug application 206111 for empagliflozin and metformin hydrochloride (SYNJARDY) tablets. Both supplemental new drug applications are sponsored by Boehringer Ingelheim Pharmaceuticals, Inc., of Ridgefield, Connecticut, for the proposed additional indication in adult patients with type 2 diabetes mellitus and high cardiovascular risk to reduce the risk of all-cause mortality by reducing the incidence of cardiovascular death and to reduce the risk of cardiovascular death or hospitalization for heart failure. The meeting will take place beginning at 8 a.m. at the Hilton Hotel & Executive Meeting Center Plaza Ballroom, Rockville, Maryland.
Tuesday, 6/28 – Wednesday, 6/29 –
The Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee
will meet to discuss investigator interest in exploring potential pediatric development plans for four products in various stages of development for adult cancer indications. The subcommittee will consider and discuss issues concerning diseases to be studied, patient populations to be included and possible study designs in the development of these products for pediatric use. The discussion will also provide information to the agency pertinent to the formulation of written requests for pediatric studies, if appropriate. The products under consideration on June 28 are: Venetoclax by Abbvie, based in Chicago; Tazemetostat by Epizyme based in Cambridge, Massachusetts; and Tecentriq by Roche/Genentech, based in San Francisco. The products under consideration on June 29 are: LOXO-101 by Loxo Oncology based in Stamford, Connecticut, and entrectinib by Ignyta based in San Diego. Additionally, information will be presented on the current unmet clinical need regarding the nearly uniformly fatal brain tumor, diffuse intrinsic pontine glioma, which occurs predominantly in the pediatric age group. The meeting will take place beginning at 8 a.m. on both days, on the FDA’s White Oak Campus, Silver Spring, Maryland.
Thursday, 6/30 –
The FDA will hold a public workshop on Clinical Trial Design Considerations for Malaria Drug Development Media
. The FDA is interested in discussing the scientific challenges pertaining to malaria drug development and malaria parasite detection methods used as endpoints in clinical trials. 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 the design of clinical trials evaluating new drugs to treat malaria. The input from this public workshop will also help in developing topics for future discussion. The workshop will take place beginning at 8:30 a.m., on the FDA’s White Oak Campus, Silver Spring, Maryland.
On the Web:
In Case You Missed It:
Thursday, 6/23 –
FDA Voice Blog: FDA: A Great Place for Science and for Scientists on the New Frontier of Regulatory Science
. As FDA Commissioner, Robert M. Califf, M.D., is proud of our agency’s extraordinary commitment to using the best available science to support our mission to protect and promote the health of the American public. This is especially critical today, as rapid scientific and technological advances are helping to expand our understanding of human biology and underlying disease mechanisms and to identify the molecular profile of a food contaminant. But there’s another benefit that derives from our application of cutting-edge science to the challenges we face, which has become increasingly evident to him through his conversations with some of FDA’s more than 10,000 scientists. And that’s the deep personal and professional satisfaction gained from working in the FDA’s state-of-the-art laboratories on front-line issues that make a real difference in the lives of all.
Wednesday, 6/22 –
FDA Voice Blog: FDA Celebrates the 40th Anniversary of the Medical Device Amendments
. In 1976, President Ford signed the Medical Device Amendments that closed the dangerous gap between what he called the FDA’s “horse and buggy authority” and “laser age problems.” Unlike the pharmaceutical industry, which was born from large chemical companies that discovered medical uses for the products they made, the device industry sprung to life as a scrappy sibling—mostly mom-and-pop businesses addressing the needs of individual patients and physicians through invention.
Tuesday, 6/21 –
FDA Voice Blog: Important steps toward streamlining access to investigational drugs for patients in need
. The FDA is only too aware that there are many patients who have a serious or life-threatening medical condition for which there is no available FDA-approved therapy. For such patients, one option may be to obtain access to an investigational drug that has not yet been approved by the FDA. To do this, a physician submits an application to the FDA requesting authorization to use the investigation drug in the treatment of their patient. This is called expanded access to investigational drugs.
Tuesday, 6/21 –
FDA Voice Blog: CBER Laboratories in the Life Sciences-Biodefense Complex
. Wise management of research programs means more than selecting projects that will yield the most scientific information but also making sure that we are making wise use of the dollars we allot for research. That’s why the FDA’s Center for Biologics Evaluation and Research thinks strategically when it plans research programs by the more than 70 principal investigators who work in our two-year-old laboratories in the Life Sciences-Biodefense Complex at the FDA’s White Oak campus.
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