Devices
FDA has cleared a Chemence Medical 510(k) to market and sell Exofin Fusion, a new skin closure system for medium to large wounds. The device combines a self-adhering flexible mesh strip, mesh anchors and a 2-octyl cyanoacrylate topical adhesive to close and seal large incisions while forming
FDA Policy/General
As part of the HHS regulatory priorities for FY 2018, FDA will amend its regulations on the information patients receive for outpatient-administered prescription drugs. And to encourage more consumer-directed care, the agency plans to propose regulations to facilitate access to more treatments for common conditions by using new
Devices
FDA has cleared a Gel-e Inc. 510(k) for its adhesive bandage for prescription and over-the-counter use in managing moderately to heavily exuding chronic wounds and acute wounds. Under medical supervision, the bandage may be used for managing pressure sores, diabetic ulcers, leg ulcers, donor sites and
Drugs
FDA has accepted a Bristol-Myers Squibb supplemental BLA for priority review of Opdivo (nivolumab) plus Yervoy (ipilimumab) to treat intermediate- and poor-risk patients with advanced renal cell carcinoma. The submission is based on data from the Phase 3 CheckMate-214 study, which was stopped early based on the
FDA Policy/General
FDA commissioner Scott Gottlieb says the agency’s 2018 policy goals include regulatory changes for drugs and medical devices. Writing in an FDA Voice online blog post, Gottlieb says the agency will issue several regulations on drug compounding to help ensure the quality of medicines that patients need. “We want
Drugs
FDA says it has created a Web site to provide direct and timely access to information about when bacterial or fungal infections are likely to respond to a specific drug. “This approach is intended to aid healthcare processionals in making more informed prescribing decisions that will both benefit their patients
Drugs
FDA has released the FDA-483 following an 11/20-11/30 inspection at Shilpa Medicare Limited, a sterile and non-sterile drug manufacturer in Telangana, India. Inspection observations shown on the form were: * redacted * scientific rationale could not be provided for some commercial product specifications; * procedures for the cleaning
Drugs
FDA has published a guidance, Systemic Antibacterial and Antifungal Drugs: Susceptibility Test Interpretive Criteria Labeling for NDAs and ANDAs, with recommendations on fulfilling new labeling requirements for susceptibility test interpretive criteria for prescription systemic antibacterial and antifungal drugs as established by the 21st Century Cures Act. Included are the agency’
FDA Policy/General
Federal Register notice: FDA is sending to OMB an information collection extension request for “Data To Support Drug Product Communications as Used by FDA: OMB Control Number 0910-0695.” The information collection is used to form opinions on a specific topic and as a qualitative research tool for two major
Drugs
The American Hospital Association says there are actions FDA could take to reduce the regulatory burden on hospital and health systems and their patients regarding drug compounding and medical device cyber issues. The association’s comment letter recommends: * elimination of a provision in a 4/2016 FDA draft guidance that
Drugs
The Biotechnology Innovation Organization (BIO) says a draft FDA guidance on format and content of a Risk Evaluation and Mitigation Strategy (REMS) document should include additional requirements for REMS programs run or administered through specialty pharmacy healthcare settings. The additional requirements should include enhanced/expanded communication with prescribers and/or
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Refuse to File: NDA and BLA Submissions to CDER” that is intended to clarify certain circumstances under which the Center may refuse to file an application. It also addresses the importance of submitting a complete application to minimize any
Drugs
Tremeau Pharmaceuticals says it has recently reached agreement with FDA on the development requirements to support an NDA for TRM-201 (rofecoxib), indicated as a as a non-opioid pain alternative for treating hemophilic arthropathy (HA). Rofecoxib was once marketed by Merck as Vioxx, but it was pulled from the
FDA Policy/General
Federal Register notice: FDA has established a “Susceptibility Test Interpretive Criteria Web site” that is intended to help efficiently update such criteria for antimicrobial drugs when necessary for public health and to allow for more efficient development and evaluation of antimicrobial susceptibility test devices. The Web site was mandated by
Devices
FDA has approved a Boston Scientific PMA for the Vercise Deep Brain Stimulation System and its use for treating symptoms of Parkinson’s disease. The device works by stimulating a targeted region of the brain through implanted leads that are powered by an implantable pulse generator. Approval was based on
FDA Policy/General
The Medical Information Working Group (MIWG) says that while in some cases it is appropriate for FDA to eliminate existing regulations, such as where they lack clarity or are inconsistent with current policy reflected in guidance documents, it also believes that, in some areas, regulatory burdens are alleviated when agencies
FDA Policy/General
Federal Register notice: FDA has determined that Merck’s Noroxin (norfloxacin) tablets, 400 mg, was not withdrawn due to safety or effectiveness concerns. The determination will allow FDA to approve ANDAs citing the reference product if all other legal and regulatory requirements are met. Noroxin is indicated for treating adults
FDA Policy/General
FDA has asked the Office of Management and Budget to clear two studies to determine the ability of consumers and healthcare professionals to detect and report deceptive presentations in prescription drug promotion. The studies will focus on two different health conditions. CDER’s Office of Prescription Drug Promotion says that
Drugs
A 5/25-5/26 FDA inspection at Seindni Co., Seoul, Korea, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 12/5 Warning Letter. The letter says the agency investigators found that the company failed to establish a quality control unit and
Drugs
FDA has issued a draft guidance, Gluten in Drug Products and Associated Labeling Recommendations, to give drug manufacturers agency recommendations on how certain drug products should be labeled regarding gluten. “Some individuals with celiac disease have faced difficulty when trying to determine whether specific drug products contain gluten,” the document
Devices
Three CDRH staffers working in the Early Feasibility Studies (EFS) program that the number of investigational device exemptions (IDE) submitted for EFS has more than doubled from 26 submissions in the first year after the EFS guidance was finalized to 57 submitted in FY 2017. Writing in an FDA Voice
Drugs
FDA has issued a draft guidance, Refuse to File: NDA and BLA Submissions to CDER, to clarify circumstances under which CDER may refuse to file new or supplemental NDAs and BLAs for therapeutic products regulated by the Center. The guidance also is to underscore the importance of submitting a complete