Latest Federal Register Notices
BIOLOGICS
Info on Xenotransplantation Sent to OMB
Federal Register Notice: FDA’s proposed collection of information, “PHS Guideline on Infectious Disease Issues in Xenotransplantation,” 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.
DEVICES
Guidance on Interoperable Medical Devices
Federal Register Notice: FDA is making available a draft guidance entitled Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices. The agency aims to assist industry and FDA staff in identifying specific considerations related to the ability of electronic medical devices to safely and effectively exchange and use exchanged information. This document highlights considerations that should be included in developing and designing interoperable medical devices and provides recommendations for the content of premarket submissions and labeling for such devices. To download this guidance, click here. To view this notice, click here.
FDA Seeks Selectors, Nominations for Mammography Panel
Federal Register Notice: FDA is requesting that industry organizations interested in participating in selecting nonvoting industry representatives to serve on the National Mammography Quality Assurance Advisory Committee (NMQAAC) for CDRH notify FDA in writing. The agency is also requesting nominations for nonvoting industry representatives to serve on the NMQAAC. To view this notice, click here.
Comment Period Extended on Device Signals Guidance
Federal Register Notice: FDA is extending the comment period for the draft guidance entitled Public Notification of Emerging Postmarket Medical Device Signals ('Emerging Signals') until 3/29 due to. unanticipated high-level of interest from external stakeholders and the medical device community. To view this notice, click here.
FDA, Xavier Univ. Plan Device Conference
Federal Register Notice: FDA’s Cincinnati District and Xavier University will co-sponsor a public conference 5/4-6 entitled “FDA/Xavier Medical Device Conference (MedCon).” It includes presentations from key FDA officials and industry experts with small group break-out sessions. It will be held 5/4 and 5/5, 8:30 a.m. to 5 p.m. and 5/6 from 8:30 a.m. to 12:05 p.m. at Xavier University, 3800 Victory Pkwy., Cincinnati, OH. Contact Gina Brackett, (513) 679-2700, email: gina.brackett@fda.hhs.gov. To view this notice, click here.
HUMAN DRUGS
Izba Not Withdrawn for S&E
Federal Register Notice: FDA has determined that Izba (travoprost ophthalmic solution), 0.003 %, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve ANDAs for travoprost ophthalmic solution/drops, 0.003 %, if all other legal and regulatory requirements are met. To view this notice, click here.
Comments Sought on WHO Narcotic Restrictions
Federal Register Notice: FDA is providing an opportunity interested persons to submit written comments and to request an informal public meeting on recommendations by the World Health Organization to impose international manufacturing and distributing restrictions, under international treaties, on certain drug substances. The five drug substances involved are: acetylfentanyl, MT-45, para-Methoxymethylamphetamine, [alpha]-pyrrolidinovalerophenone ([alpha]-PVP); para-Methyl-4-methylaminorex (4,4'-DMAR), and phenazepam. The comments received in response to this notice and/or public meeting will be considered in preparing the U.S. position on these proposals for a meeting of the United Nations Commission on Narcotic Drugs in Vienna, Austria in March. Comments should be submitted by 2/25. To view this notice, click here.
FDA, Xavier Univ. Plan PharmaLink Conference
Federal Register Notice: FDA Cincinnati District, in co-sponsorship with Xavier University will hold a public conference entitled “FDA/Xavier University PharmaLink Conference: Increasing Product Confidence”. The PharmaLink conference seeks solutions to important and complicated issues by aligning with the strategic priorities of FDA, featuring presentations from key FDA officials, global regulators, and industry experts. The conference will be held on 3/16, from 8:30 a.m. to 5 p.m.; 3/17, from 8:30 a.m. to 5p.m.; and 3/18 from 8:30 a.m. to 12:20 p.m. at Xavier University, 3800 Victory Pkwy., Cincinnati, OH. Contact Mason Rick, Xavier University, (513) 745-3016, rickm@xavier.edu. To view this notice, click here.
FDA Releases Product-Specific BE Guidance
Federal Register Notice: FDA is making available additional draft and revised draft product-specific bioequivalence (BE) recommendations for 31 products. The recommendations provide product-specific guidance on the design of BE studies to support ANDAs. The products include recommendations for alprostadil, betamethasone dipropionate, ciclesonide, and elvitegravir. To view this notice, click here.
Draft Guidance on Lamotrigine BE Recommendations
Federal Register Notice: FDA is making available revised draft guidance for industry on lamotrigine extended-release tablets entitled Draft Guidance on Lamotrigine. The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support ANDAs for lamotrigine extended-release tablets. To view this notice, click here.
GENERAL
Comments Sought on Combo Product Assignment Procedure
Federal Register Notice: FDA seeks public comments on the procedure by which an applicant may obtain an assignment or designation determination for combination products. Comments should be submitted by 3/28. To view this notice, click here.