Latest Federal Register Notices
GENERAL
Comments Extended on Advisory Committee Appearances Guide
Federal Register Notice: FDA has extended the comment period until 11/26 for a guidance on “Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees.” The extension is being granted due to errors displayed on the FDA Web site pertaining to this guidance. To view this notice, click here.
HUMAN DRUGS
Guidance on Generic Facility Self-Identification
Federal Register Notice: FDA has made available a guidance on “Self-Identification of Generic Drug Facilities, Sites, and Organizations.” The document is intended to assist industry with meeting the self-identification requirement. It explains who is required to self-identify, what information must be requested, how the information should be submitted, and what the penalty is for failure to self-identify. To view the guidance, click here. To view this notice, click here.
Committee to Discuss Hypogonadism Drug Trial Designs
Federal Register Notice: FDA has announced a 12/6 meeting of its Bone, Reproductive and Urologic Drugs Advisory Committee. The committee will discuss appropriate clinical trial design features, including acceptable endpoints for demonstrating clinical benefit, for drugs intended to treat secondary hypogonadism while preserving or improving testicular function, including spermatogenesis. To view this notice, click here.
Fycompa Regulatory Review Period for Patent Extension
Federal Register Notice: FDA has determined the regulatory review period for Eisai’s NDA for Fycompa (perampanel) that applies to a patent extension for the product. FDA determined that the applicable regulatory review period is 3,274 days. To view this notice, click here.
Myalept Regulatory Review Period for Patent Extension
Federal Register Notice: FDA has determined the regulatory review period for an Amylin Pharmaceuticals NDA for Myalept (metreleptin for injection) that applies to a patent extension for the product. FDA determined that the applicable regulatory review period is 6,509 days. To view this notice, click here.
Belviq Regulatory Review Period for Patent Extension
Federal Register Notice: FDA has determined the regulatory review period for an Eisai NDA for Belviq that applies to a patent extension for the product. FDA determined that the applicable regulatory review period is 2,928 days. To view this notice, click here.
Draft Guidance on Determining When REMS is Necessary
Federal Register Notice: FDA has released a draft guidance entitled “FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary.” The document is intended to clarify how the agency applies certain factors in determining whether a risk evaluation and mitigation strategy (REMS) is necessary to ensure that the benefits of a drug outweigh its risks. To view the guidance, click here. To view this notice, click here.
Draft Guide on Coordinated Antimicrobial Drug/Test Development
Federal Register Notice: FDA has announced the availability of a draft guidance entitled “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices.” The document is intended to assist drug sponsors and device manufacturers who are planning to develop new antimicrobial drugs and antimicrobial susceptibility test (AST) devices and who seek to coordinate product development so that the AST device could be cleared at the time of new drug approval. To view the guidance, click here. To view this notice, click here.
Armenpharm ANDA Withdrawn for Safety/Effectiveness
Federal Register Notice: FDA is suspending approval of an Armenpharm, Ltd. ANDA for chloramphenicol capsules, 250 mg because previous versions of chloramphenicol were withdrawn from sale for reasons of safety or effectiveness. The agency says it will not accept or approve ANDAs for chloramphenicol capsules, 50 mg and 100 mg, or chloramphenicol palmitate oral suspension, 150 mg/5 mL. To view this notice, click here.
Risk Communication Advisory Panel to Review Strategic Plan
Federal Register Notice: FDA’s Risk Communication Advisory Committee has planned an 11/7 meeting to discuss and make recommendations on the agency’s draft “Strategic Plan for Risk Communication and Health Literacy.” The plan is intended to clarify how the agency can communicate the benefits and risks of FDA-regulated products to target audiences more effectively. The panel will also hear presentations on some of FDA’s external communications and how these communications relate to the draft plan. To view this notice, click here.
FDA Announce Naloxone Mobile App Competition
Federal Register Notice: FDA is announcing the 2016 FDA Naloxone App Competition, a prize competition designed to help reduce deaths associated with prescription opioid and heroin overdose by seeking innovative approaches to help reduce preventable harm associated with the drugs. The goal is to spur innovation around the development of a low-cost, scalable, crowd-sourced mobile phone application that helps increase the likelihood that opioid users, their immediate personal networks, and first responders are able to identify and react to an overdose by administering naloxone, a medication that reverses the effects of opioid overdose. To view this notice, click here.
MEDICAL DEVICES
Magnetic Surgical Instrument Device Classified as Class 2
Federal Register Final Order: FDA has classified the Magnetic Surgical Instrument System into Class 2 (special controls). The special controls that will apply to the device are identified in the order and will be part of the codified language for the magnetic surgical instrument system’s classification. To view this order, click here.
Guidance on Reporting Device Studies on Computational Modeling
Federal Register Notice: FDA has released a guidance entitled “Reporting of Computational Modeling Studies in Medical Device Submissions.” The document provides recommendations to industry on the formatting, organization, and content of reports of computational modeling and simulation studies that are used as valid scientific evidence to support medical device submissions, and to assist FDA staff in the review of such submissions. To view the guidance, click here. To view this notice, click here.
FDA Posts Revised Listing of Device Consensus Standards
Federal Register Notice: FDA has announced a publication containing modifications to the agency’s list of standards it recognizes for use in premarket reviews (FDA Recognized Consensus Standards). The document, “Modifications to the List of Recognized Standards, Recognition List Number: 045,” is intended to assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. To view this notice, click here.
Product Radiation Committee to Mull Device Performance Standards
Federal Register Notice: FDA has announced a 10/25-26 public advisory committee meeting of the Technical Electronic Product Radiation Safety Standards Committee. On 10/25, the committee will discuss and make recommendations on possible FDA performance standards for the following: Radiofrequency radiation products, such as microwave ovens and wireless power transfer; laser products, including an update to amendments to the laser rule, light detection and ranging, laser data (Light Fidelity-LiFi)/energy transfer, illumination applications and infrared applications; sunlamp products including an update on the performance standards amendments; and non-coherent light sources (e.g., LEDs and UVC lamps) including new initiatives. On 10/26, the committee will make recommendations on possible performance standards for the following: International Electrotechnical Commission standards versus performance standards for medical devices; computed tomography; radiography and fluoroscopy; diagnostic and therapeutic ultrasound; and radiation therapy. To view this notice, click here.
Strabismus Detection Device Into Class 2
Federal Register Final Order: FDA has classified the strabismus detection device into Class 2 (special controls). The special controls are identified in this order and will be part of the codified language for the strabismus detection device’s classification. To view this order, click here.