Devices
Focus Diagnostics has begun a Class 1 recall of its Direct Amplification Discs supplied with the Simplexa HSV 1 & 2 Direct (MOL2150), Simplexa Flu A/B & RSV Direct (MOL2650) and Simplexa Group A Strep Direct kits (MOL2850) because they may result in a false negative result, a false
Devices
The American Optometric Association (AOA) has filed a complaint with FDA urging it to take legal action against an online vision test being marketed by Opternative, Inc. without the type of testing and pre-market approvals frequently required of new medical device technology. The online test produces a prescription for
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for Brintellix (vortioxetine hydrobromide) is 2,343 days for extending a patent that claims the human drug product. Brintellix is indicated for treating major depressive disorder. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that the agency will not begin procedures to withdraw approval of ANDAs that refer to these drug products, and it will allow
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry entitled Labeling for Biosimilar Products. It is intended to assist applicants in developing draft prescription drug labeling for proposed biosimilar products and pertains only to the prescribing information (commonly referred to as the package insert). To download this
Drugs
FDA scientists have provided “proof-of-concept” for a technique that identifies the presence of potentially harmful contaminants in probiotics. “The technique eliminates a product’s beneficial bacteria and allows any potentially harmful contaminants in the product to grow unimpeded, allowing detection of potentially harmful contaminants using standard laboratory methods,
Devices
FDA has approved a CardioFocus PMA for its HeartLight Endoscopic Ablation System for treating patients with paroxysmal atrial fibrillation (AF). The device differs from other AF options that rely on x-ray or mapping support for guidance, by allowing the electrophysiologist to control the delivery of therapeutic laser energy “for
Devices
A Duke-Margolis Center for Health Policy white paper outlines the business practices of a proposed independent coordinating center that would guide the future development and implementation of CDRH’s national evaluation system for medical devices. Establishing the device evaluation system is a top strategic priority for 2016-2017. The
FDA Policy/General
Federal Register Notice: FDA is making available “Modifications to the List of Recognized Standards, Recognition List Number: 041” containing modifications it is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication will assist manufacturers who elect to declare conformity with
FDA Policy/General
Federal Register Proposed rule: FDA is proposing to amend the regulation describing lesser administrative actions that may be imposed on an Institutional Review Board (IRB) that has failed to comply with FDA’s IRB regulations. It is clarifying that FDA may require the IRB to withhold approval of new FDA-
FDA Policy/General
Former FDA chief counsel Sheldon Bradshaw and two other partners from Hunton & Williams have joined King & Spalding’s life sciences practice. Bradshaw left FDA in 2007 to join Hunton & Williams. He previously served as Department of Justice (DoJ) Office of Legal Counsel deputy assistant attorney general. Prior
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry and public health stakeholders entitled Emergency Use Authorization of Medical Products and Related Authorities. Its purpose is to explain FDA’s current thinking about policies on the authorization of the emergency use of certain medical products under certain
FDA Policy/General
Federal Register Proposed rule: FDA is proposing to amend its nonprescription (over-the-counter, or OTC) drug regulations. If finalized as proposed, the rule would supplement the time and extent application (TEA) process for OTC drugs by establishing timelines and performance metrics for FDA’s review of non-sunscreen TEAs,
FDA Policy/General
BIOLOGICS FDA Publishes Notice of Biosimilar Patent Infringement Action Federal Register Notice: FDA is publishing notice that an applicant for a proposed biosimilar product notified the agency that a patent infringement action was filed in connection with the applicant’s BLA. The agency has received notice of the following complaint:
FDA Policy/General
Dr. Reddy’s Laboratories and XenoPort have entered into a license agreement that grants Dr. Reddy’s exclusive U.S. rights for developing and commercializing XenoPort’s clinical-stage oral new chemical entity XP23829 for treating moderate-to-severe chronic plaque psoriasis. The therapy is also being considered for treating
FDA Policy/General
DEVICES Bracco Diagnostics has received FDA approval for Lumason for use in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients. The company says it is the first to receive approval for this clinical use of ultrasound contrast both in adults and children. CardioFocus
Drugs
Janssen Research & Development says it is discontinuing a Phase 3 development program for fulranumab in osteoarthritis pain. The decision was based on “strategic portfolio prioritization and was not based on any emerging safety concerns from the Phase 3 clinical studies with fulranumab,” it says. Additionally, affiliate Janssen Pharmaceuticals is
FDA Policy/General
Federal Register Notice: FDA is publishing notice that an applicant for a proposed biosimilar product notified the agency that a patent infringement action was filed in connection with the applicant’s BLA. The agency has received notice of the following complaint: Amgen, Inc., v. Apotex, Inc., 15-cv-61631 (consolidated
FDA Policy/General
Federal Register Notice: FDA is publishing a list of information collections that have been approved by the Office of Management and Budget: Prescription Drug User Fee Cover Sheet; Form FDA 3397 and Food Additives; Food Contact Substances Notification System. To view this notice, click here.
FDA Policy/General
Federal Register Correction: FDA corrects a 3/30 Federal Register rule, which amended the animal drug regulations to reflect 11-12/2015 NADA and ANADA approvals and to make technical amendments. On page 17608, change amendatory instruction 33 to read as follows: 033. In Sec. 524.1044g, in paragraph (b)
Devices
The FDA says it is aware of allegations that Boston Scientific’s urogynecologic surgical mesh may contain counterfeit raw material, and it is requiring the company to conduct additional testing to determine whether or not mesh manufactured from the alleged counterfeit raw material are equivalent to mesh manufactured from the
Drugs
CDER’s Office of Prescription Drug Promotion (OPDP) has objected to a Shionogi “Patient Co-Pay Assistance Voucher” for Ulesfia (benzyl alcohol) lotion because it omits important risk information associated with the use of Ulesfia and omits material facts. As such, the voucher misbrands Ulesfia and makes its distribution violative,