Drugs
The 6th Circuit Court of Appeals says a lawsuit alleging failure of a generic drug company to provide a Medication Guide with a prescription for the anti-arrythmia drug amiodarone is preempted by federal law. Attorney Michelle Yeary (Reed Smith) writes in an online blog post that this was the
FDA Policy/General
FDA 7/3 posted the latest batch of Warning Letters while FDA Webview was closed for its annual holiday break. They can be accessed by clicking on the link following each letter. Foshan Jinxiong Technology Foshan City, China (6/26): FDA inspected the firm 8/2017 and cited significant GMP
Drugs
Fagron Sterile Services has recalled two lots of neostigmine methylsulfate 5ml syringes after a confirmed customer complaint that some syringe units are incorrectly labeled as neostigmine methylsulfate 1mg/ml, 3mg per 3ml. “In the event that 5ml rather than the intended 3ml is administered to a patient, adverse events from
Drugs
Drawing from a Science article, The BMJ says the FDA drug approval process “may be tainted by financial conflicts of interest with drug companies that are based not only on present and past ties, but also on future ones that may be created. The BMJ’s post says the Science
Drugs
A 10/23-10/27/17 FDA inspection at Sichuan Friendly Pharmaceutical Co., Sichuan, China, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients. A 6/22 Warning Letter says the specific deviations were: * failing to ensure that all specifications and test procedures are scientifically
Drugs
Two Hyman, Phelps, and McNamara attorneys say the Justice Department (DoJ) is quietly implementing a policy asking that various law enforcement entities appropriately coordinate in imposing penalties on a company, to “avoid the risk of repeated punishments that may exceed what is necessary to rectify the harm and deter future
Devices
FDA has cleared an IsoRay 510(k) for its GammaTile brachytherapy technology that uses proprietary Cesium-131 seeds within customizable collagen-based carriers for treating recurrent brain tumors. The therapy “leverages Cesium-131’s unique ability to deliver a highly targeted dose of intense radiation treatment while limiting radiation exposure
Drugs
Rep. Frank Pallone (D-NJ), ranking Democrat on the House Energy and Commerce Committee, says the committee should hold a hearing to examine misuse of the FDA Risk Evaluation and Mitigation Strategies (REMS) program by drug companies looking to block, impede, or delay generic competitors from coming to market. In
Drugs
FDA has cleared an Oculocare Medical 510(k) for Alleye, a mobile medical software application indicated for detecting and monitoring age-related macular degeneration (AMD). The device is designed to detect and characterize central and paracentral metamorphopsia (visual distortion) in patients with macular conditions including AMD and diabetic retinopathy. After
Drugs
An 8/15-8/18/17 FDA inspection at Foshan Jinxiong Technology, Foshan City, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 6/26 Warning Letter. Specific violations noted in the letter, were: * failing to have, for each batch of drug
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products — Content and Format.” The document’s recommendations are intended to help ensure that the labeling is clear, concise, useful, and informative and, to the extent possible,
FDA Policy/General
Federal Register notice: FDA is seeking comments on a information collection extension for “General Licensing Provisions; Section 351(k) Biosimilar Applications” (OMB Control Number 0910-0719). The collection is related to the Biologics Price Competition and Innovation Act of 2009 that amended the Public Health Service Act and other statutes
FDA Policy/General
DEVICES FDA has approved Bausch + Lomb’s Ultra contact lenses for extended wear for up to six nights and seven days of continuous wear. The contact lenses include the company’s MoistureSeal technology, a patented combination of material and manufacturing process that helps to maintain 95% of lens moisture for
FDA Policy/General
Draft Guide on Drug Indications Labeling Federal Register notice: FDA makes available a draft guidance entitled “Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products — Content and Format.” 07/09/2018 Comments Sought on Biosimilar Info Collection Federal Register notice: FDA seeks comments on a information
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.” The document addresses FDA’s implementation of the biosimilar user fee program and certain changes in policies and procedures. To view the notice, click here.
Drugs
FDA has approved a Pulmonx PMA for the Zephyr Endobronchial Valve, intended to treat breathing difficulty associated with severe emphysema. “Using a flexible bronchoscope, a doctor places Zephyr Valves, similar in size to pencil erasers, into the diseased areas of the lung airways during a procedure in a hospital setting,
Devices
FDA has cleared an Arthrosurface 510(k) to market the Patellofemoral WaveKahuna Arthroplasty System. The implants are intended to restore the articular surface geometry of the patella and femoral trochlea while maintaining a patient’s native anatomy, according to the company. Their extended lateral aspect and trochlear geometry are designed
Drugs
Federal Register notice: FDA has announced a 2018 CDER and CBER staff experiential learning site visit program specific to its Quality Metrics Program. The proposed program is in response to input from a variety of stakeholders over the past couple of years. The purpose of the site visit program is
Drugs
FDA says it is stepping up pressure on drug compounding facilities, particularly those preparing topical pain creams comprised of multiple ingredients. “Oftentimes, at least one of the ingredients is an active ingredient in an FDA-approved topical pain cream, such as lidocaine,” an agency release says. Other ingredients is these
Drugs
FDA is advising health care professionals not to use BioDiagnostics International’s Monsel’s Solution (ferric subsulfate 20%) because the drug product was made under poor conditions. The product is used to stop bleeding after medical procedures, such as a colposcopy and a biopsy. The solution is sold in a
FDA Policy/General
In observance of the Fourth of July (Independence Day) holiday in the U.S., the news operations of FDA Webview are closed until Monday, July 9. The next overnight email news bulletin from this site will be issued that evening.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations.” The document discusses how to design appropriate nonclinical studies before beginning first-in-human trials and through product approval. In addition, it provides recommendations for product labeling, such as duration of