Latest Federal Register Notices
BIOLOGICS
Guidance on Biologics License Provisions
Federal Register Notice: FDA is making available a draft guidance for industry entitled Implementation of the ‘Deemed to be a License’ Provision of the Biologics Price Competition and Innovation Act of 2009. It describes the agency’s approach to implementing the statutory provision under which an application for a biological product approved under the FD&C Act on or before 3/23/20, will be deemed to be a license for the biological product under the Public Health Service Act on 3/23/20. The draft guidance also provides recommendations to sponsors of proposed protein products intended for submission in an application that may not receive final approval under the FD&C Act on or before 3/23/20, to facilitate alignment of product development plans with the agency’s interpretation of the transition provisions of the BPCI Act. To download this guidance, click here. To view this notice, click here.
Comments Sought on Biosimilar Biologic Workload
Federal Register Notice: FDA is seeking comments on the final results of a study of the workload volume and full costs associated with the process for the review of biosimilar biological product applications (final report). This study was conducted by an independent consulting firm, and it fulfills FDA’s statutory requirement under the first authorization of the Biosimilar User Fee Act of 2012, which enables FDA to collect user fees for the review of biosimilar biological applications for fiscal years 2013 to 2017. To view this notice, click here.
FDA Sends Info to OMB on E-Submission of Device Registration
Federal Register Notice: FDA’s proposed collection of information, “Electronic Submission of Medical Device Registration and Listing — 21 CFR Part 807, Subparts A Through D” 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.
Guidance on Controlling Bacterial Risk in Blood Platelets
Federal Register Notice: FDA is making available a draft guidance: Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion. It provides blood collection establishments and transfusion services with recommendations to control the risk of bacterial contamination of room temperature stored platelets intended for transfusion by implemeting pathogen reduction technology or bacterial testing. It also provides recommendations for the use of secondary testing of platelets as the basis to extend the dating period of platelets, when appropriately labeled bacterial detection devices and storage containers are used. The guidance replace the draft guidance entitled Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion, dated 12/2014 and when finalized, is intended to supersede the recommendation in section VII.A.2, on bacterial contamination testing in the document entitled Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods dated 12/2007. To download this guidance, click here. To view this notice, click here.
Panel to Hear Research Updates
Federal Register Notice: FDA’s Vaccines and Related Biological Products Advisory Committee will meet 5/11 from 1 p.m. to 4:30 p.m. at FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The committee will participate via teleconference. In open session, the committee will hear updates of the research program in the CBER’s Laboratory of Bacterial Polysaccharides, Division of Bacterial, Parasitic, and Allergenic Products. Contact Sujata Vijh or Rosanna Harvey, (240) 402-7107, sujata.vijh@fda.hhs.gov, or (240) 402-8072, rosanna.harvey@fda.hhs.gov. To view this notice, click here.
HUMAN DRUGS
Panels to Discuss Opioid Analgesics REMS
Federal Register Notice: FDA’s Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee will meet 5/3-4 at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The committees will discuss results from assessments of the extended-release and long-acting Opioid Analgesics Risk Evaluation and Mitigation Strategies (REMS). The agency will seek the committees’ comments as to whether this REMS with Elements to Assure Safe Use assures safe use, is not unduly burdensome to patient access to the drugs, and to the extent practicable, minimizes the burden to the healthcare delivery system. Contact Stephanie L. Begansky, (301) 796-9001. To view this notice, click here.
Workshop on Pediatric Safety Studies
Federal Register Notice: FDA’s Office of Pediatric Therapeutics and CDER are announcing a two-day public workshop 4/13-14 entitled “Advancing the Development of Pediatric Therapeutics: Successes and Challenges of Performing Long-Term Pediatric Safety Studies.” Its purpose is for FDA to have an open discussion with experts in the field examining the need and path forward for long-term pediatric safety studies. Day 1 of the public workshop will focus on an exposition of the successes and challenges of long-term safety studies in children. Day 2 will focus on suggestions for the future on study design and implementation of long-term safety studies in children. Viewpoints of patient representatives of children with chronic conditions and industry will be included. The workshop will be held from 8 a.m. to 5 p.m. at The DoubleTree by Hilton Hotel--Bethesda, 8120 Wisconsin Ave., Bethesda, MD. Contact Renan A. Bonnel, (301) 796-8654. To view this notice, click here.
FDA-ISPE Conference Slated
Federal Register Notice: CDER and the International Society for Pharmaceutical Engineering (ISPE) will co-sponsor the “Fifth Annual FDA-ISPE Quality Conference” 6/6-8. Its purpose is to discuss manufacturing, compliance, and management practices that create, implement, and sustain a culture of high quality and result in reliable pharmaceutical and biologic products that support patient health. The meeting will be held from 8:30 a.m. to 4 p.m. at the Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Rd., Bethesda, MD. Contact Susan Krys, (301) 364-9202, email: skrys@ispe.org, or Sau (Larry) Lee, (301) 796-2905, email: Sau.Lee@fda.hhs.gov. To view this notice, click here.
Panel to Discuss Sarepta NDA for Duchenne Muscular Dystrophy
Federal Register Notice: FDA’s Peripheral and Central Nervous System Drugs Advisory Committee will meet 4/25, from 8 a.m. to 5:30 p.m. at the Park Marriott Hotel and Conference Center, Chesapeake Ballroom, 3501 University Blvd. East, Hyattsville, MD. This meeting is a reschedule of a postponed meeting announced in the 12/18/15 Federal Register originally scheduled for 1/22. The committee will discuss a Sarepta Therapeutics NDA for eteplirsen injection for intravenous infusion for treating Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping. Contact Moon Hee V. Choi, (301) 796-9001. To view this notice, click here.
16 Drug Products Not Withdrawn for S&E
Federal Register Notice: FDA has determined that the drug products listed in this document including Kenalog, Indocin, Bactrim and Bactrim Pediatric, and Nitropress 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.
Panels to Discuss KenPharm Abuse-Deterrent Pain Product
Federal Register Notice: FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee will meet 5/5, 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 committees will be asked to discuss a KenPharm, Inc. NDA for benzhydrocodone/acetaminophen oral tablets for short-term (up to 14 days) management of acute pain. The product has been formulated with the intent to provide abuse-deterrent properties. Benzhydrocodone is a hydrocodone prodrug which, according to the applicant, is rapidly converted into hydrocodone by enzymes in the gastrointestinal tract. The committees will be asked to discuss whether the applicant has demonstrated abuse-deterrent properties for their product that would support labeling, and whether the nasal route of abuse is relevant for combination products made up of hydrocodone and acetaminophen. Contact Stephanie L. Begansky, (301) 796-9001. To view this notice, click here.
Panel to Discuss Sanofi Aventis NDAs for Diabetes
Federal Register Notice: FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will meet 5/24, 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 the safety and efficacy of Sanofi Aventis NDAs for insulin glargine and lixisenatide injection, a fixed ratio drug product consisting of insulin and a GLP-1 receptor agonist, and for lixisenatide injection, a GLP-1 receptor agonist, submitted proposed for treating adults with Type 2 diabetes mellitus. Contact LaToya Bonner, (301) 796-9001. To view this notice, click here.
Panel to Discuss Novo Nordisk NDA for Diabetes
Federal Register Notice: FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will meet 5/25 from 8 a.m. to 5 p.m. at FDA White Oak Campus, Building 31 Conference Center, the Great Room (Rm. 1503), 10903 New Hampshire Ave., Silver Spring, MD. The committee will discuss the safety and efficacy of a Novo Nordisk NDA for insulin degludec and liraglutide injection for the proposed indication: Adjunct to diet and exercise to improve glycemic control in the treatment of adults with Type 2 diabetes mellitus. Contact LaToya Bonner, (301) 796-9001. To view this notice, click here.
Panels to discuss Teva NDA for Severe Pain
Federal Register Notice: FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee will meet 6/7, from 8 a.m. to 4 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The committees will be asked to discuss a Teva Branded Pharmaceutical Products R&D NDA for hydrocodone bitartrate extended-release tablets for managing pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The product is an extended-release formulation intended to have abuse-deterrent properties based on its physicochemical properties. The committees will be asked to discuss whether the data submitted by the applicant are sufficient to support labeling of the product with the properties expected to deter abuse. Contact Stephanie L. Begansky, (301) 796-9001. To view this notice, click here.
Panels to Discuss Pfizer NDA to Treat Severe Pain
Federal Register Notice: FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee will meet 6/8 from 8 a.m. to 4 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The committees will be asked to discuss a Pfizer NDA for oxycodone hydrochloride and naltrexone hydrochloride extended-release capsules with the proposed indication of managing pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The product is an extended-release formulation intended to have abuse-deterrent properties based on the presence of naltrexone, an opioid antagonist, in the formulation. The committees will be asked to discuss whether the data submitted by the applicant are sufficient to support labeling of the product with the properties expected to deter abuse. Contact Stephanie L. Begansky, (301) 796-9001. To view this notice, click here.
FDA Debars McQuerry
Federal Register Notice: FDA is issuing an order under the Federal Food, Drug, and Cosmetic Act permanently debarring Wesley A. McQuerry from providing services in any capacity to a person that has an approved or pending drug product application. McQuerry was convicted of a felony under federal law for conduct relating to the development or approval, including the process for development or approval, of a drug product and otherwise relating to the regulation of a drug product under the FD&C Act. To view this notice, click here.
VETERINARY
Comments Sought on Oxitec GE Mosquito Release
Federal Register Notice: FDA is making available for public comment the draft environmental assessment submitted by Oxitec Ltd. and a preliminary finding of no significant impact in support of an investigational release of OX513A Aedes aegypti genetically-engineered mosquitoes under an investigational new animal drug exemption. It is a part of an existing mosquito control program in Key Haven, FL. The strain of Ae. aegypti mosquito’s recombinant DNA construct encodes a conditional lethality trait such that the offspring of the matings of male OX513A mosquitoes and wild type Ae. aegypti do not survive to adulthood with the intended result of a decrease in the overall population of Ae. aegypti in the environment. Comments should be submitted by 4/13. To view this notice, click here.
Comments Sought on Recordkeeping on Ruminant Animal Feed
Federal Register Notice: FDA seeks comments on extending Office of Management and Budget approval on the existing recordkeeping requirements for this information collection on animal proteins prohibited in ruminant feed. Comments should be submitted by 5/16. To view this notice, click here.
Guidance on CMC Section of Animal Drug Apps
Federal Register Notice: FDA is making available a draft guidance for industry entitled Question-Based Review for the Chemistry, Manufacturing, and Controls Technical Section of Animal Drug Applications. In order to improve the process for submission and CMC information for animal drugs, CVM has developed a series of questions that focus on the critical scientific and regulatory issues and pharmaceutical attributes essential for ensuring the quality of new animal drug substances and products. The Question-based Review provide a general framework for original CMC submissions to investigational new animal drug files, generic investigational new animal drug files, new animal drug applications, abbreviated new animal drug applications, conditional approval of applications for conditional approval, and veterinary master files. To download this guidance, click here. To view this notice, click here.
GENERAL
CBER/CDER to End Support Define.xml Version 1.0
Federal Register Notice: CBER and CDER are announcing the end of support for Version 1.0 of Clinical Data Interchange Standards Consortium Case Report Tabulation Data Definition Specification (Define.xml) and an update to the FDA Data Standards Catalog. Use of Define.xml Version 2.0, which has been available since 3/2013, is the newer standard supported by the agency. FDA support for Define.xml Version 1.0 will end for studies that start 12 months after 3/15/2017. To view this notice, click here.
FDA Sends Info on DTC TV Ads to OMB
Federal Register Notice: FDA’s proposed collection of information, “Quantitative Information in Direct-to-Consumer Television Advertisements,” has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. To view this notice, click here.
Comments Sought on Drug/Biologic IND Safety Reporting
Federal Register Notice: FDA seeks comment on “Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans.” Comments should be submitted by 5/17. To view this notice, click here.