Latest Federal Register Notices
BIOLOGICS
Panel to Discuss Amgen’s Humira Biosimilar
Federal Register Notice: FDA will hold a meeting of the Arthritis Advisory Committee 7/12, from 7:30 a.m. to 5 p.m. at : FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The committee will discuss an Amgen BLA for a proposed biosimilar to AbbVie Inc.'s Humira (adalimumab). The proposed indications for this product are: (1) Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs)); (2) reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 4 years of age and older (alone or in combination with methotrexate); (3) reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis (alone or in combination with non-biologic DMARDs); (4) reducing signs and symptoms in adult patients with active ankylosing spondylitis; (5) reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy (ABP 501 would be indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab); (6) inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (the effectiveness of ABP-501 would not be established in patients who have lost response to or were intolerant to TNF blockers); and (7) treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate (only to be administered to patients who will be closely monitored and have regular follow-up visits with a physician). Contact Moon Hee V. Choi, (301) 796-9001. To view this notice, click here.
DEVICES
FDA Posts List of Recognized Device Standards
Federal Register Notice: FDA is releasing “Modifications to the List of Recognized Standards, Recognition List Number: 042,” a publication containing modifications it is making to the list of standards that it recognizes for use in premarket device review. It will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. To view this notice, click here.
Guidance on Benefit-Risk Considerations for Device Enforcement
Federal Register Notice: FDA is making available a draft guidance entitled Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions. It is intended to provide clarity for FDA staff and industry on the benefit and risk factors the agency may consider in prioritizing resources for compliance and enforcement efforts to maximize medical device quality and patient safety. To download this guidance, click here. To view this notice, click here.
Guidance on ISO Biological Evaluation of Devices
Federal Register Notice: FDA is making available a guidance entitled Use of International Standard ISO 10993-1, `Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process.’ FDA aims to assist industry in preparing PMAs, Humanitarian Device Exceptions, Investigational Device Applications (IDEs), Premarket Notifications (510(k)s), and de novo requests for medical devices that come into direct contact or indirect contact with the human body in order to determine the potential for an unacceptable adverse biological response resulting from contact of the component materials of the device with the body. The purpose of this guidance is to provide further clarification and updated information on the use of International Standard ISO 10993-1, “Biological evaluation of medical devices--Part 1: Evaluation and testing within a risk management process” to support applications to FDA. This guidance supersedes Office of Device Evaluation (ODE) Blue Book Memorandum #G95-1 (1995), entitled “Use of International Standard ISO-10993, ‘Biological Evaluation of Medical Devices — Part 1: Evaluation and Testing.’” To download this guidance, click here. To view this notice, click here.
FDA Issues 2 EUAs for Zika Diagnostics
Federal Register Notice: FDA is issuing two Emergency Use Authorizations for two in vitro diagnostic devices for detecting Zika virus in response to the Zika virus outbreak in the Americas. FDA issued these authorizations under the FD&C Act, as requested by Focus Diagnostics, Inc., and Altona Diagnostics GmbH. To view this notice, click here.
Review Period Set for Zilver PTX Stent
Federal Register Notice: FDA has determined the regulatory review period for Boston Scientific Scimed, Inc’s Zilver PTX Drug Eluting Peripheral Stent is 3,075 days for extending patents that claim the medical device.The stent is indicated for improving luminal diameter for the treatment of de novo or restenotic symptomatic lesions in native vascular disease of the above-the-knee femoropopliteal arteries having reference vessel diameters from 4 mm to 9 mm and total lesion lengths up to 140 mm per limb and 280 mm per patient. To view this notice, click here.
Review Period Set for Cook Medical’s Zilver PTX Stent
Federal Register Notice: FDA has determined the regulatory review period for Cook Medical’s Zilver PTX Drug Eluting Peripheral Stent is 3,075 days for extending a patent that claims the medical device. The stent is indicated for improving luminal diameter for the treatment of de novo or restenotic symptomatic lesions in native vascular disease of the above-the-knee femoropopliteal arteries having reference vessel diameters from 4 millimeters (mm) to 9 mm and total lesion lengths up to 140 mm per limb and 280 mm per patient. To view this notice, click here.
HUMAN DRUGS
Guidance on Osteoporosis Drugs
Federal Register Notice: FDA is making available a draft guidance for industry entitled Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment. It provides recommendations to industry for designing a nonclinical development program to support approval of drugs to treat osteoporosis. It also discusses the nonclinical development of biopharmaceuticals (e.g., recombinant proteins and monoclonal antibodies). To download this guidance, click here. To view this notice, click here.
Pediatric Oncology Subcommittee to Meet
Federal Register Notice: FDA will hold a meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee6/28 from 8 a.m. to 3:15 p.m. and 6/29, from 8 a.m. to 4:15 p.m. at FDA’s White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. On 6/28 information will be presented to gauge investigator interest in exploring potential pediatric development plans for four products in various stages of development for adult cancer indications. The products under consideration are AbbVie’s Venetoclax, Epizyme’s Tazemetostat, Roche/Genentech’s Atezolizumab. On 6/29 during the morning session, information will be presented to gauge investigator interest in exploring potential pediatric development plans for two products in various stages of development for adult cancer indications: Loxo Oncology’s Loxo-101 and Ignyta’s Entrectinib. During the afternoon session, information will be presented on the current unmet clinical need in the nearly uniformly fatal brain tumor, diffuse intrinsic pontine glioma, which occurs predominantly in the pediatric age group. Contact Lauren D. Tesh, (301) 796-9001. To view this notice, click here. To view this notice, click here.
FDA Sets Review Period for Orbactive
Federal Register Notice: FDA has determined the regulatory review period for Eli Lilly’s Orbactive oritavancin diphosphate) is 6,539 days for extending a patent that claims the human drug product. Orbactiv is indicated for treating adult patients with acute bacterial skin and skin structure infections caused or suspected to be caused by susceptible isolates of designated Gram-positive microorganisms. To view this notice, click here.
FDA Releases Product-Specific BE Recommendations
Federal Register Notice: FDA is making available additional draft and revised draft product-specific bioequivalence (BE) recommendations. They provide product-specific guidance on the design of BE studies to support ANDAs. The products include amcinonide, cobimetinib fumarate, selexipag, and tacrolimus. To view this notice, click here.
Guidance on Chewable Tablet Quality
Federal Register Notice: FDA is making available a draft guidance for industry entitled Quality Attribute Considerations for Chewable Tablets. It describes the agency’s thinking on the critical quality attributes that should be assessed when developing a chewable tablet dosage form and recommends that the selected acceptance criteria be appropriate and meaningful indicators of product performance throughout the shelf life of the product. To download this guidance, click here. To view this notice, click here.
TOBACCO
Tobacco Center Seeks Facility Visit Participants
Federal Register Notice: FDA’s Center for Tobacco Products is inviting participation in its Tobacco Product Manufacturing Facility Visits. The program is intended to give FDA staff an opportunity to visit facilities involved in the manufacturing of newly deemed tobacco products and their components and parts, including any related laboratory testing, and to observe the manufacturing operations of the tobacco industry. Those interested should submit either an electronic or written request for participation by 8/15. To view this notice, click here.
Info on Youth Tobacco Prevention Sent to OMB
Federal Register Notice: FDA’s proposed collection of information, “Evaluation of FDA’s General Market Youth Tobacco Prevention Campaigns,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. To view this notice, click here.
VETERINARY
Guidance on Veterinary Parenteral Dosage Forms
Federal Register Notice: FDA is making available a guidance for industry entitled Modified Release Veterinary Parenteral Dosage Forms: Development, Evaluation, and Establishment of Specifications. It provides recommendations on the submission of chemistry, manufacturing, and controls and pharmacokinetic information, as well as procedures to follow, to support the approval of modified release parenteral drug products intended for use in veterinary species. This guidance is applicable to both new animal drug applications and ANDAs. To view this notice, click here.
GENERAL
FDA to Allow Symbols without Text in Device/Biologic Labeling
Federal Register Final rule: FDA is revising its medical device and certain biological product labeling regulations to explicitly allow for the optional inclusion of graphical representations of information, or symbols, in labeling (including labels) without adjacent explanatory text (referred to in this document as “stand-alone symbols”) if certain requirements are met. The final rule also specifies that the use of symbols, accompanied by adjacent explanatory text continues to be permitted. FDA is also revising its prescription device labeling regulations to allow the use of the symbol statement “Rx only” or ‘‘℞ only’’ in the labeling for prescription devices. To view this notice, click here.
Pediatric Clinical Investigator Workshop
Federal Register Notice: FDA’s Office of Pediatric Therapeutics, and the Eunice Kennedy Shriver National Institute of Child Health and Human Development will hold a two-day public workshop 9/12-13 entitled “Pediatric Clinical Investigator Training.” Its purpose is to provide investigators with training and expertise in designing and conducting clinical trials in pediatric patients that will lead to appropriate labeling. The training course is intended to provide investigators with: (1) A clear understanding of some of the challenges of studying products in the pediatric population, including: pediatric study design, neonates, biomarkers, endpoints, orphan drugs and rare disease trial design, formulations; (2) an overview of extrapolation as it relates to the pediatric population; and (3) an overview of ethically appropriate methods related to the design of clinical trials in the pediatric population.
The workshop will be held from 8 a.m. to 4 p.m. at the DoubleTree Bethesda, 8120 Wisconsin Ave., Bethesda, MD. Contact Terrie L. Crescenzi, terrie.crescenzi@fda.hhs.gov; or Betsy Sanford, elizabeth.sanford@fda.hhs.gov. To view this notice, click here.