Latest Federal Register Notices

BIOLOGICS

Guidance on Biotherapeutic Products Clinical Trials
Federal Register Notice: FDA is making available a guidance: Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Guidance for Industry. It provides investigational new drug application (IND) sponsors with recommendations on IND submissions for early clinical trials with live biotherapeutic products in the U.S. The document updates a guidance of the same title dated 2/2012 by addressing when the label on the commercially available products(s) would be considered adequate to satisfy the purpose of the chemistry, manufacturing, and control (CMC) information requirements. To download this guidance, click here. To view this notice, click here.

DEVICES

FDA Releases New Device Standards List
Federal Register Notice: FDA is making available a publication containing modifications it is making to the list of standards that the agency recognizes for use in premarket device reviews. This publication, entitled “Modifications to the List of Recognized Standards, Recognition List Number: 043” will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. To view this notice, click here.

Panel to Discuss OTC Diagnostic Tests
Federal Register Notice: FDA will hold a meeting of the Microbiology Devices Panel of the Medical Devices Advisory Committee 8/16, from 8 a.m. to 6 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 and make recommendations regarding the appropriateness of clearing or approving of over-the-counter (OTC) diagnostic tests for the detecting pathogens causing infectious diseases, focusing on respiratory and sexually transmitted infections. Currently, there are no OTC diagnostic tests for infectious diseases cleared or approved by CDRH. The committee will evaluate the risks and benefits to individual patients and to public health associated with clearing or approving OTC diagnostic tests for infectious diseases. Serious risks such as false negative results, false positive results, patient loss to medical followup, and the impact on surveillance of reportable infections will be addressed. Potential benefits such as reduction of infection transmission and increased access to testing will be discussed as well. The committee will also make recommendations on clinical study design, analytical study design, and acceptable performance criteria applicable to respiratory and STI diagnostic devices. To view this notice, click here.

FDA Classifies Electrosurgical Devices into Class 2
Federal Register Final order: FDA is classifying the electrosurgical device for over-the-counter aesthetic use into Class 2 (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the electrosurgical device for over-the-counter aesthetic use's classification. To view this final order, click here.

HUMAN DRUGS

Comments Extended on Hepatitis C Drugs Guidance
Federal Register Notice: FDA is extending the comment period for a 5/4 notice of availability of the draft guidance for industry entitled Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment. FDA is taking this action due to maintenance on the Federal eRulemaking portal from 7/1-7/5. Comments should be submitted by 7/19. To view this notice, click here.

Panels to Discuss Egalet NDA
Federal Register Notice: FDA's Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee will meet 8/4 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 discuss an Egalet U.S. NDA for morphine sulfate extended-release tablets 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. It has been formulated with the intent to provide abuse-deterrent
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 Philip A. Bautista, (301) 796-9001. To view this notice, clickhere.

Revised BE Guidance on Paliperidone Palmitate
Federal Register Notice: FDA is making available a revised document: Draft Guidance on Paliperidone Palmitate. The recommendations provide specific guidance on the design of bioequivalence studies to support ANDAs for paliperidone palmitate extended-release injectable suspension. To download the guidance, click here. To view this notice, click here.

Guidance on Drugs for Treating Herpes
Federal Register Notice: FDA is making available a draft guidance for industry entitled Recurrent Herpes Labialis: Developing Drugs for Treatment and Prevention. Its purpose is to assist sponsors in all phases of development of treatments for recurrent herpes labialis. The guidance also addresses preventing recurrent herpes labialis and outlines the types of nonclinical studies and clinical trials recommended throughout the drug development process to support approval of antiviral drug products for the treatment or prevention of recurrent herpes labialis. To download this guidance, clickhere. To view this notice, click here.

Guidance on Elemental Drug Impurities
Federal Register Notice: FDA is making available a draft guidance for industry entitled Elemental Impurities in Drug Products. It provides recommendations on the control of elemental impurities of human drug products marketed in the U.S. consistent with implementation of International Council for Harmonization (ICH) guidance for industry Q3D Elemental Impurities. This draft guidance will also assist manufacturers of compendial drug products in responding to the issuance of the United States Pharmacopeia requirement for the control of elemental impurities. To download this guidance, click here. To view this notice, click here.

Guidance on Vulvovaginal Candidiasis Drugs
Federal Register Notice: FDA is making available a draft guidance for industry entitled Vulvovaginal Candidiasis: Developing Drugs for Treatment. Its purpose is to assist sponsors in the clinical development of drugs for treating uncomplicated vulvovaginal candidiasis. To download this guidance, click here. To view this notice, click here.

Workshop on Erythropoietic Protoporphyria Treatments
Federal Register Notice: FDA is sponsoring a public workshop 10/24 and seeking public comment on Erythropoietic Protoporphyria (EPP). The workshop is intended to discuss how best to facilitate and expedite the development of safe and effective drug therapies to treat signs and symptoms related to EPP. FDA will provide information for, and gain perspective from, patients and patient advocacy organizations, health care providers, academic experts, and industry on disease symptoms and its impact on daily life, experience with current treatment regimens for EPP, and various aspects of clinical development of products intended to treat EPP. The workshop will be held from 10 a.m. to 4 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. Contact Meghana Chalasani (240) 402-6525, Meghana.Chalasani@fda.hhs.gov. To view this notice, click here.

Comments Extended on Special Protocol Guidance
Federal Register Notice: FDA is extending the comment period for a 5/4 notice of availabilityof the draft guidance for industry entitled Special Protocol Assessment. FDA is taking this action due to maintenance on the Federal eRulemaking portal from 7/1-7/5. Comments should be submitted by 7/19. To view this notice, click here.

FDA Releases Quality Metrics Guide
Federal Register Notice: FDA is making available a Technical Specifications Document entitled “Quality Metrics Technical Conformance Guide, Version 1.0.” It provides technical recommendations for the submission of quality metric data. It serves as the technical reference for implementation of the draft FDA guidance for industry when finalized, Request for Quality Metrics dated 7/28/15. To view this notice, click here.

Guidance on Advisory Committee Meeting Participation
Federal Register Notice: FDA is making available a draft guidance entitled Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees; Guidance for the Public, FDA Advisory Committee Members, and FDA Staff. It addresses FDA's process, under government-wide federal regulations, for evaluating whether an advisory committee member has an appearance issue that raises concerns about the member's participation in an advisory committee meeting and describes the agency's process for determining whether to authorize a member with an appearance issue to participate in the advisory committee meeting. FDA is also requesting comment on whether FDA should request that each advisory committee member who has an appearance issue and who has received an authorization from FDA to participate in an advisory committee meeting voluntarily publicly disclose the authorization. To download this guidance, click here. To view this notice, clickhere.

Guidance on Accepting Gifts to FDA
Federal Register Notice: FDA is making available a draft guidance for the public and FDA staff entitled Gifts to FDA: Evaluation and Acceptance. The Secretary of the Department of Health and Human Services has the authority to accept conditional or unconditional gifts on behalf of the U.S. The Secretary has delegated this gift authority to the FDA Commissioner. This guidance provides the process and principles it will use in implementing this authority. To download this guidance, click here. To view this notice, click here.

Import Data Proposed for FDA-Regulated Entries through Customs
Federal Register Proposed rule: FDA is proposing to establish requirements for the electronic filing of entries of FDA-regulated products in the Automated Commercial Environment (ACE) or any other electronic data interchange system authorized by the U.S. Customs and Border Protection Agency (CBP), in order for the filing to be processed by CBP and to help FDA in determining admissibility of that product. ACE is a commercial trade processing system operated by CBP that is designed to implement the International Trade Data System, automate import and export processing, enhance border security, foster U.S. economic security through lawful international trade and policy, and to replace the Automated Commercial System. To view this proposed rule, click here.