Devices
Sage Products has recalled one lot of Comfort Shield Barrier Cream Cloths due to contamination (Burkholderia cepacia) concerns. Topical administration of a product with B. cepacia may cause serious infections in patients whose bodies cannot fight disease or in hospitalized patients, an FDA recall notice says. The cloths are used
FDA Policy/General
Federal Register Notice: FDA is announcing the fiscal year (FY) 2017 rates for the establishment and re-inspection fees related to entities that compound human drugs and elect to register as outsourcing facilities under the FD&C Act. This document establishes the FY 2017 rates for the small business
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Guidance for Tobacco Retailers on Tobacco Retailer Training Programs,” 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.
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Guidance for Industry: Electronic Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction
FDA Policy/General
Federal Register Notice: FDA is requesting that any industry organizations interested in participating in selecting a nonvoting member to represent the interests of tobacco growers to serve on the Tobacco Products Scientific Advisory Committee, notify the agency in writing. FDA is also requesting nominations for a nonvoting member to represent
FDA Policy/General
IBM says it has developed a new lab-on-a-chip technology that can separate biological particles at the nanoscale down to 20 nanometers in diameter that allow scientists access to particles such as DNA, viruses and exosomes. According to the current issue of the journal Nature Nanotechnology, upon separation,
FDA Policy/General
BIOLOGICS Panel to Discuss Southern Hemisphere Influenza Vaccine Federal Register Notice: FDA will hold a meeting 10/13 of the Vaccines and Related Biological Products Advisory Committee. The committee will meet in open session to discuss and make recommendations on the selection of strains to be included in an influenza
Devices
CDRH has posted a Medical Device Single Audit Program document that outlines the control of quality records generated under the pilot program. The pilot is testing the feasibility of conducting a single regulatory audit of a medical device manufacturer’s quality management system that will satisfy the requirements of five
Drugs
FDA has granted Shire a fast track designation for SHP626 (volixibat), an investigational drug for treating adults who have nonalcoholic steatohepatitis (NASH) with liver fibrosis. The company is developing SHP626 as a once daily, orally-administered inhibitor of the apical sodium dependent bile acid transporter, a protein that it says
Devices
A CDRH webinar has reviewed medical device biocompatibility issues addressed in a recent a guidance on “Use of International Standard ISO 10993-1 — Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process.” The Center says the document is intended to assist industry in preparing
FDA Policy/General
Senator Charles Schumer (D-NY) has urged FDA to launch an investigation into deceptive sun protection factor (SPF) marketing, following a study released by Consumer Reports which suggests that 43% of sunscreen products fail to meet the SPF claim on the label. “There is simply no doubt about it—some
Drugs
A team of NIH researchers has developed a new software tool called AptaTRACE for drug developers and other scientists who want to identify molecules that bind with high precision to targets of interest. “This research is an excellent example of how the benefits of ‘big data’ critically depend upon the
FDA Policy/General
Federal Register Notice: FDA is announcing the fee rates and payment procedures for medical device user fees for fiscal year 2017. The standard fee (adjusted base amount) for a premarket application, including a BLA, and for a premarket report and a BLA efficacy supplement, is $234,495 for FY 2017.
FDA Policy/General
Federal Register Notice: FDA is making available a guidance entitled General Wellness: Policy for Low Risk Devices. It is intended to provide clarity to industry and FDA staff on CDRH’s compliance policy for low-risk products that promote a healthy lifestyle (general wellness products). To download this guidance, click
Devices
FDA has approved a Transcend Medical PMA for the CyPass Micro-Stent System (Model 241-S), a glaucoma surgical device for use in combination with cataract surgery. The is intended to help reduce intraocular pressure (IOP) in adult patients with mild to moderate primary open-angle glaucoma. The CyPass System
FDA Policy/General
Federal Register Notice: FDA is announcing the rates for biosimilar user fees for fiscal year 2017. Under the Biosimilar User Fee Act of 2012 (BsUFA) the initial and annual biological product development (BPD) fee rates for a fiscal year are equal to 10% of the fee rate established under the
FDA Policy/General
Federal Register Notice: FDA is seeking public comment on requests for feedback submitted under the Pre-Submission program for medical devices. A guidance on the topic provides recommendations on the information that should be submitted in a Pre-Submission package and procedures that should be followed for meetings between CDRH
FDA Policy/General
Federal Register Notice: FDA will hold a meeting 9/14 of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The meeting will be held from 8 a.m. to 5 p.m. FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center,
FDA Policy/General
Federal Register Notice: FDA will hold a meeting of the Oncologic Drugs Advisory Committee 9/14, from 8 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 will discuss
Devices
FDA has cleared an Itamar Medical 510(k) to expand the medical indication for its WatchPAT for sleep apnea diagnosis. The clearance covers the device’s use in patients aged 12 and older. The previous clearance was for use in those aged 17 and older. WatchPAT is a small wrist
Drugs
FDA has conditionally accepted an Evoke Pharma proprietary brand name submission to name its product candidate, EVK-001 (metoclopramide nasal spray), “Gimoti.” The full submission will be included in a planned NDA submission. The name Gimoti (pronounced “jye-MOH-tee”) was developed in compliance with the agency’s guidance on
Drugs
FDA has approved a Sanofi-Aventis NDA for Adlyxin (lixisenatide), a once-daily injection to improve glycemic control in adults with Type 2 diabetes. The glucagon-like peptide-1 receptor agonist was approved based on data from 10 clinical trials that enrolled 5,400 patients with Type 2 diabetes. It