Latest Federal Register Notices

BIOLOGICS

FDA Renews Blood Panel
Federal Register Notice: The FDA has renewed the charter of the Blood Products Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 5/13/18. To view this notice, click here.

Blood Products Panel to Meet
Federal Register Notice: FDA plans a meeting of the Blood Products Advisory Committee 6/20 from 9:30 a.m. to 1 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 committee members will participate in the meeting via teleconference and in open session will discuss the research programs in the Laboratory of Plasma Derivatives CBER’s Division of Hematology Research and Review, Office of Blood Research and Review. Contact Bryan Emery or Joanne Lipkind, (240) 402-8054, bryan.emery@fda.hhs.gov, and (240) 402-8106, joanne.lipkind@fda.hhs.gov. To view this notice, click here.

DEVICES

Info on Humanitarian Device Exemptions Sent to OMB
Federal Register Notice: FDA’s proposed collection of information, “Information To Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements,” 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 Device Postmarket Surveillance
Federal Register Notice: FDA is making available a guidance entitled Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act. It is intended to assist manufacturers of devices subject to Section 522 postmarket surveillance orders by providing an overview of the Federal Food, Drug, and Cosmetic Act, information on how to fulfill section 522 obligations, and recommendations on the format, content, and review of postmarket surveillance plan submissions. To download this guidance, click here. To view this notice, click here.

FDA Publishes Approved PMAs
Federal Register Notice: FDA is publishing a list of 14 premarket approval applications that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency’s Division of Dockets Management. These PMAs include Torax Medical’s Fenix Continence Restoration System, Animas Corp.’s Animas Vibe System, and LivaNova Canada Corp.’s Perceval Sutureless Heart Valve. To view this notice, click here.

Comments Extended on Electrical Stimulation Devices
Federal Register Proposed rule: FDA is extending the comment period for a 4/25 proposed rule in which the agency requested comments for a ban on electrical stimulation devices (ESDs) used for self-injurious or aggressive behavior. Comments should be submitted by 7/25. To view this notice, click here.

HUMAN DRUGS

Panel to Discuss 2 sNDAs for Diabetes
Federal Register Notice: FDA will hold a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee 6/28, from 8 a.m. to 5 p.m., at Hilton Washington DC/Rockville Hotel & Executive Meeting Center, Plaza Ballroom, 1750 Rockville Pike, Rockville, MD. The committee will discuss two Boehringer Ingelheim Pharmaceuticals supplemental NDAs for Jardiance (empagliflozin) tablets and Synjardy (empagliflozin and metformin hydrochloride) tablets. They are for the proposed additional indication in adult patients with Type 2 diabetes mellitus and high cardiovascular risk to reduce the risk of all-cause mortality by reducing the incidence of cardiovascular death and to reduce the risk of cardiovascular death or hospitalization for heart failure. Contact LaToya Bonner, (301) 796-9001. To view this notice, click here.

FDA Renews Peripheral and CNS Drugs Panel
Federal Register Notice: The FDA has renewed the Peripheral and Central Nervous System Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 6/4/18. To view this notice, click here.

FDA Renews Drug Safety and Risk Management Panel
Federal Register Notice: The FDA commissioner has renewed the Drug Safety and Risk Management Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 5/31/18. To view this notice, click here.

Workshop on Diabetes Outcome Measures
Federal Register Notice: CDER is sponsoring a public workshop 8/29 entitled “Diabetes Outcome Measures Beyond Hemoglobin A1c (HbA1c).” Its purpose is to have a forum for dialogue with the public, patients, patient advocacy groups and industry to gain greater appreciation on the extent to which the current regulatory paradigm for antidiabetic drug therapies addresses the needs of patients with diabetes and to identify additional outcomes, beyond HbA1c, that are of direct relevance and importance to patients living with the disease. The workshop will be held from 9 a.m. to 5 p.m. at FDA’s White Oak campus, 10903 New Hampshire Ave., Building 31 (The Great Room B, and C), Silver Spring, MD. Contact Francis Kalush, DIABHbA1c-CDER@fda.hhs.gov. To view this notice, click here.

Guidance on Drugs for COPD
Federal Register Notice: FDA is making available a draft guidance for industry entitled Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment. It is intended to assist sponsors in designing a clinical development program for new drug products for treating chronic obstructive pulmonary disease. This document revises the draft guidance of the same name issued 11/9/07 by adding information onthe St. George’s Respiratory Questionnaire. To download the guidance, click here. To view this notice, click here.

GENERAL

Guidance on Histopathology to Support Biomarkers
Federal Register Notice: FDA is making available a guidance for industry entitled Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification. It is intended to assist submitters of a biomarker for qualification that conduct nonclinical biomarker qualification studies in which histopathology is used as a reference or truth standard. It discusses the processes that FDA recommends that submitters consider when generating histopathology data to be included in biomarker studies and outlines the scientific standards recommended for histopathology used in nonclinical biomarker characterization and qualification. It finalizes the draft guidance Use of Histology in Biomarker Qualification Studies, issued 12/2011. To download this guidance, click here. To view this notice, click here.

Guidance on Use of E Health Records in Trials
Federal Register Notice: FDA is making available a draft guidance for industry entitled Use of Electronic Health Record Data in Clinical Investigations. It is intended to assist sponsors, clinical investigators, contract research organizations, institutional review boards, and other interested parties on the use of electronic health record data in FDA-regulated clinical investigations. To download this guidance, click here. To view this notice, click here.

FDA Files Closed A/C Panel Meetings with Library of Congress
Federal Register Notice: FDA has filed with the Library of Congress the annual reports of those FDA advisory committees that held closed meetings during fiscal year 2015. These are CBER’s Blood Products Advisory Committee, National Center for Toxicological Research’s Science Board to the National Center for Toxicological Research, CDER’s Bone, Reproductive Health Drugs Advisory Committee and the Joint Meetings of the Anesthetic and Analgesic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. To view this notice, click here.