Latest Federal Register Notices
BIOLOGICS
Comments Sought on Human Tissue Info
Federal Register Notice: FDA is seeking comments on the proposed information collection requirements relating to FDA regulations for human tissue intended for transplantation. Comments should be submitted by 8/5. To view this notice, click here.
Comments Extended on Biosimilar Guidance
Federal Register Notice: FDA is extending the comment period for a 4/4 Federal Register notice on a draft guidance entitled Labeling for Biosimilar Products; Draft Guidance for Industry. Comments should be submitted by 8/2. To view this notice, click here.
Comments Sought on Biologic and HCT/P Deviations Reporting
Federal Register Notice: FDA is seeking public comment on the information collection requirements relating to the reporting of biological product deviations in manufacturing and human cells, tissues, and cellular and tissue-based product (HCT/P) deviations, and Forms FDA 3486 and 3486A. Comments should be submitted by 8/8. To view this notice, click here.
Review Period Set for Biogen’s Alprolix
Federal Register Notice: FDA has determined the regulatory review period for Biogen Idec Hemophilia Inc.’s Alprolix is 2,223 days for extending patents which claim the human biological product. Alprolix is a recombinant DNA derived, coagulation Factor IX concentrate indicated in adults and children with hemophilia B for controlling and preventing bleeding episodes, perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes. To view this notice, click here.
Review Period Set for Eloctate
Federal Register Notice: FDA has determined the regulatory review period for Biogen Idec Hemophilia Inc.’s Eloctate is 1,695 days for extending patents which claim the human biological product. Eloctate is a recombinant DNA derived, antihemophilic factor indicated in adults and children with Hemophilia A (congenital Factor VIII deficiency) for controlling and preventing bleeding episodes, perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes. To view this notice, click here.
Cellular, Tissue and Gene Therapies Panel to Meet
Federal Register Notice: FDA will hold a meeting of the Cellular, Tissue and Gene Therapies Advisory Committee 7/26 from 1 p.m. to 3:30 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The committee will meet by teleconference. In open session, the committee will hear updates of research programs in the Laboratory of Biological Chemistry and Laboratory of Molecular Oncology, Division of Biotechnology Review and Research 1 and 4, Office of Biotechnology Products, CDER. Contact Janie Kim or Denise Royster, (301) 796-9016 or (240) 402-8158, email: Janie.Kim@fda.hhs.gov or Denise.Royster@fda.hhs.gov. To view this notice, click here.
FDA Terminates TSE Advisory Committee
Federal Register Final rule: FDA is terminating the Transmissible Spongiform Encephalopathies Advisory Committee effective 6/9. In recent years, the number of issues requiring committee advice has declined, and it has met very infrequently and thus the effort and expense of maintaining this advisory committee is no longer justified. Any relevant Transmissible Spongiform Encephalopathy issues in the future could be addressed by the agency’s other advisory committees, such as the Blood Products Advisory Committee. To view this final rule, click here.
Arthritis Panel to Discuss Enbrel Biosimilar
Federal Register Notice: FDA will hold a meeting 7/13 of the Arthritis Advisory Committee, 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 a Sandoz BLA for GP2015, a proposed biosimilar to Amgen Inc.’s Enbrel (etanercept). The proposed indications are: (1) Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (in combination with methotrexate (MTX) or used alone); (2) reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients ages two and and older; (3) reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis (in combination with MTX in patients who do not respond adequately to MTX alone); (4) reducing signs and symptoms in patients with active ankylosing spondylitis; and (5) treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Contact Moon Hee Choi, (301) 796-9001. To view this notice, click here.
Panel to Discuss Valeant Pharma BLA for Psoriasis
Federal Register Notice: FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee will meet 7/19, from 8 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 a Valeant Pharmaceuticals Luxemborg BLA for brodalumab injection, a human monoclonal antibody for the proposed use for treating moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. Contact Jennifer Shepherd, (301) 796-9001. To view this notice, click here.
Review Period Set for Tanzeum
Federal Register Notice: FDA has determined the regulatory review period for Human Genome Sciences, Inc.’s Tanzeum is 3,014 days for extending a patent which claims the human biological product. Tanzeum is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus. To view this notice, click here.
DEVICES
Guidance on Device Patient-Specific Info
Federal Register Notice: FDA is making available a draft guidance entitled Dissemination of Patient-Specific Information from Devices by Device Manufacturers. The agency intends to facilitate the appropriate and responsible dissemination of patient-specific information recorded, stored, processed, retrieved, and/or derived from medical devices from manufacturers to patients. The guidance provides recommendations to industry, healthcare providers, and FDA staff about the mechanisms and considerations for device manufacturers sharing such information with patients. To download this guidance, click here. To view this notice, click here.
Nasolacrimal Compression Device into Class 1
Federal Register Final order: FDA is classifying the nasolacrimal compression device into Class 1 (general controls) in order to provide a reasonable assurance of safety and effectiveness of the device. The classification was applicable on 4/20. To view this notice, click here.
HUMAN DRUGS
Drug Products Not Withdrawn for S&E
Federal Register Notice: FDA has determined that five drug products (Apresoline, Proventil, K-Dur, Mycolog II, and Kenalog) were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. To view this notice, click here.
FDA Corrects Withdrawal of 2 Merck NDAs
Federal Register Notice: FDA is correcting a 10/13/15 Federal Register notice, which announced the withdrawal of approval of 67 NDAs and 128 ANDAs from multiple applicants, effective 11/12/15. The document indicated that FDA was withdrawing approval of two Merck NDAs: NDA 016096, Mintezol (thiabendazole) tablets, and NDA 016097, Mintezol oral suspension, after receiving a request from the NDA holder. Before withdrawal of these NDAs became effective, Merck informed FDA that it did not want approval of the NDAs withdrawn. Because the request was timely, their approval is still in effect. To view this notice, click here.
Review Period Set for Pomalyst
Federal Register Notice: FDA has determined the regulatory review period for Celgene Corp.’s Pomalyst (pomalidomide) is 3,716 days for extending a patent which claims the human drug product. Pomalyst is indicated for treating patients with multiple myeloma who have received at least two prior therapies including lenalidomide and bortezomib and have demonstrated disease progression on or within 60 days of completion of last therapy. To view this notice, click here.
Guidance on Compounding Bulk Drugs for Outsourcing Facilities
Federal Register Notice: FDA is making available guidance for industry entitled Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act. It describes FDA’s interim regulatory policy on outsourcing facilities that compound human drug products using bulk drug substances while FDA develops the list of bulk drug substances that can be used in compounding under the FD&C Act. To download this guidance, click here. To view this notice, click here.
Guidance on Compounding Bulk Drugs for Pharmacists
Federal Register Notice: FDA is making available a guidance for industry entitled Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act. It describes FDA’s interim regulatory policy on the use of bulk drug substances by licensed pharmacists in state-licensed pharmacies or federal facilities and by licensed physicians to compound human drug products while FDA develops the list of bulk drug substances that can be used in compounding under section 503A of the FD&C Act. To download this guidance, click here. To view this notice, click here.
VETERINARY
Animal Drug Regs Reflect March, April Approvals
Federal Register Final rule: FDA is amending the animal drug regulations to reflect application-related actions for NADAs and ANADAs during March and April. These are Elanco Animal Health’s Imprestor, Aratana Therapeutics’ Galliprant, and Eco’s Aivlosin mediated article. The agency is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications and the voluntary withdrawals of approval of applications that occurred in January and February. To view this final rule, click here.
FDA Withdraws 5 NADAs, 1 ANADA
Federal Register Notification of withdrawal: FDA is withdrawing approval of five NADAs and an ANADA. This action is being taken at the sponsors’ request because these products are no longer manufactured or marketed. These are Cross Vetpharm’s Sulfa-Nox Liquid, Sulfa-Nox Concentrate, Erythromycin Medicated Premix, Purina Sulfa, Supersweet Mediapak Tylan 10, and Vetoquinol’s Penicillin G Potassium. To view this notice, click here.
Guidance on Oncology Drugs for Companion Animal
Federal Register Notice: FDA is making a draft guidance available for industry entitled Oncology Drugs for Companion Animals. It provides recommendations for sponsors of investigational oncology drugs for use in companion animals (e.g., dogs, cats, and horses), discusses the contents of a NADA for certain oncology drugs, and provides recommendations on how to address human user safety concerns. To download this guidance, click here. To view this notice, click here.
GENERAL
Comments Sought on Mammography Quality Standards
Federal Register Notice: FDA seeks comments on the estimated reporting, recordkeeping, and third-party disclosure burden associated with the Mammography Quality Standards Act requirements. Comments should be submitted by 8/8. To view notice, click here.
FDA Seeks Selectors, Nominations for Advisory Panels
Federal Register Notice: FDA is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. The agency is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. To view this notice, click here.