Latest Federal Register Notices
DEVICES
Review Period Set for Supera Stent System
Federal Register Notice: FDA has determined the regulatory review period for IDEV Technologies’ Supera Peripheral Stent System is 1,894 days for extending a patent which claims the medical device. The system is indicated to improve luminal diameter in treating patients with symptomatic de novo or restenotic native lesions or occlusions of the superficial femoral artery and/or popliteal artery with reference vessel diameters of 4.0 to 6.5 millimeters (mm) and lesion lengths up to 140 mm To view this notice, click here.
Comments Extended on Interoperable Device Guidance
Federal Register Notice: FDA is extending the comment period provided in the 1/26 notice entitled Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability. Comments on the guidance should be submitted by 4/28. To view this notice, click here.
FDA Seeks Coverage Organization Input on Device Trial Design
Federal Register Notice: FDA is requesting expressions of interest from organizations that evaluate clinical evidence used to support private payer coverage decisions for medical devices that wish to provide input to medical device developers (sponsors) on clinical trial design or other plans for gathering clinical evidence needed to support positive coverage decisions. These coverage organizations include third-party commercial health insurance organizations, payer/provider organizations, health technology assessment groups and various organizations that evaluate clinical evidence and make coverage recommendations to and decisions for private payers and health plans. CDRH is taking this step to assist sponsors in identifying such organizations and soliciting clinical trial design or other evidence-gathering input from them. To view this notice, click here.
HUMAN DRUGS
Comments Sought on Hypertension Drug Labeling
Federal Register Notice: FDA is seeking public comment on the information collection associated with the guidance Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims, which is intended to assist applicants in developing labeling for outcome claims for drugs that are indicated to treat hypertension. Comments should be submitted by 4/22. To view this notice, click here.
Review Period Set for Breo Ellipta
Federal Register Notice: FDA has determined the regulatory review period for Glaxo’s Breo Ellipta is 1,980 days for extending a patent which claims the human drug product. Breo Ellipta (vilanterol trifenate; fluticasone furoate) is indicated for long-term, once-daily maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease. To view this notice, click here.
Panel to Discuss Galderma OTC Acne Drug
Federal Register Notice: FDA’s Nonprescription Drugs Advisory Committee will meet 4/15, from 8 a.m. to 5 p.m. at the Hilton Washington DC North/Gaithersburg, Grand Ballroom, 620 Perry Pkwy., Gaithersburg, MD. The committee will discuss data submitted by Galderma Laboratories, L.P. to support a supplemental NDA for over-the-counter (OTC) marketing of adapalene gel 0.1% for treating acne and to clear up acne pimples and acne blemishes for patients 12 years and older. The committee will be asked to consider whether data support an acceptable risk/benefit profile for the nonprescription use of adapalene gel 0.1% by OTC consumers. Contact Moon Hee V. Choi, (301) 796-9001. To view this notice, click here.
Workshop on Evidentiary Standards for Safety Biomarkers
Federal Register Notice: FDA and the Foundation for the National Institutes of Health Biomarkers Consortium (FNIH BC) will hold a public workshop 4/14-15 entitled “Developing an Evidentiary Standards Framework for Safety Biomarkers Qualification Workshop.” Its purpose is to discuss the evidentiary standards needed to support biomarker qualification with a particular emphasis on drug safety markers. The workshop will focus on the standards relevant to the qualification of a range of safety biomarkers and examine case studies in several different organ systems. It will be held 4/14 from 9 a.m. to 5 p.m. and 4/15, from 8 a.m. to 5 p.m. at the Bethesda North Marriott Hotel and Conference Center, 5701 Marinelli Rd., Bethesda, MD. Contact Janelle Lewis, (301) 594-2919. To view this notice, click here.
FDA Renews Gastrointestinal Drugs Panel
Federal Register Notice: The FDA commissioner is renewing the Gastrointestinal Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 3/3/18. To view this notice, click here.
TOBACCO
Workshop on Waterpipes & Waterpipe Tobacco
Federal Register Notice: FDA’s Center for Tobacco Products will hold a public workshop 3/17-18 to gather scientific information on waterpipes and waterpipe tobacco and to identify areas of research that may inform the Center’s regulation of these tobacco products. FDA is also opening a public docket to receive data, information, and comments on this topic. The workshop will be held 3/17, from 8:30 a.m. to 5 p.m. and 3/18, from 8:30 a.m. to 4 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503A), Silver Spring, MD. Individuals must register by 2/25. Contact Caryn Cohen, (877) 287-1373, workshop.CTPOS@fda.hhs.gov. To view this notice, click here.
Comments Sought on Tobacco Retailer Training Info
Federal Register Notice: FDA is seeking comments on the information collection provisions of the guidance entitled Tobacco Retailer Training Programs. Comments should be submitted by 4/26. To view this notice, click here.
GENERAL
Comments Sought on FDA Fellowship Program
Federal Register Notice: FDA is seeking public comment on a proposed collection of information in the Outcomes Evaluation Survey for Graduates of the FDA Commissioner's Fellowship Program. Comments should be submitted by 4/25. To view this notice, click here.