Drugs
West Pharmaceutical Services has recalled its Vial2Bag fluid transfer system that was manufactured between 3/15/2016 and 1/8/2019 due to the possibility that the device may not adequately transfer concentrated medication from a vial to an IV bag before infusion into a patient’s vein. If inadequate
Drugs
Congressmen Kurt Schrader (D-OR) and Earl L. Carter (R-GA) have introduced legislation aimed at keeping drug prices down by increasing competition in the generic drug market. The Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act (HR 938) would aim to prevent the
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices.” The document is intended to assist drug sponsors and device manufacturers who are planning to develop new antimicrobial drugs and antimicrobial susceptibility test devices and who seek to coordinate
FDA Policy/General
Federal Register notice: FDA has issued a guidance, Safety and Performance Based Pathway, that discusses the agency’s current thinking on expanding the concept of the abbreviated 510(k) program for demonstrating substantial equivalence for 510(k) submissions. The document’s intent is to describe an optional pathway (the Safety
FDA Policy/General
Federal Register notice: FDA has released a draft guidance entitled Survey Methodologies to Assess REMS Goals That Relate to Knowledge that gives information to industry on conducting REMS assessment surveys, used to evaluate respondent knowledge of REMS-related information. The document discusses general principles and recommendations relating to conducting REMS
Devices
FDA has cleared a Qualigen 510(k) for its FastPack IP Sex Hormone Binding Globulin Immunoassay, a biomarker used in diagnosing and treating men’s health. The FastPack IP system is described by the company as a fully automated, highly efficient blood analyzer that provides rapid, quantitative immunoassay results at
Drugs
FDA has issued Sunovion Pharmaceuticals a complete response letter on its NDA for apomorphine sublingual film for use in treating “off episodes” (the re-emergence or worsening of symptoms otherwise controlled by medications) experienced by people living with Parkinson’s disease. In the letter, FDA requested additional information and analyses,
Drugs
FDA commissioner Scott Gottlieb says the agency will advance additional policies this year to promote generic competition for complex drugs. “Among other things,” he says in a statement, “we intend to issue additional guidance documents for developing specific complex generic drugs, as well as address categories of complex drugs that
FDA Policy/General
Federal Register notice: FDA has announced a 3/21 Neurological Devices Panel of the Medical Devices Advisory Committee meeting. Panel members are scheduled to discuss and make recommendations on clinical information related to a de novo request for the NeuroAD Therapy System that was submitted by Neuronix. The device is
Devices
Breakthrough device designation requests are confidential and will not be maintained in an FDA database. That’s one of the insights gained by attorney Rachel Hunt (Hyman, Phelps & McNamara) from the question and answer period following an FDA Webinar on the program. Writing in her firm’s FDA Law
Devices
FDA is providing safety information and recommendations to help users of infusion pumps, rapid infusers, fluid warmers, and their accessory devices reduce the risk of air being introduced in a blood vessel (air-in-line) and air embolism associated with the devices. An agency safety communication says that while air-
FDA Policy/General
Federal Register notice: FDA has announced a 3/27 Pulmonary-Allergy Drugs Advisory Committee meeting. Panel members are scheduled to discuss an AllerQuest NDA for Pre-Pen Plus, a skin-test kit that combines the approved product Pre–Pen (benzylpenicilloyl polylysine for injection) with penicillin G potassium, penicilloic acid, penilloic
Devices
AdvaMed praises FDA for reopening the comment period on two coronary drug-eluting stent guidances that are 10 years old. In its comment letter, the association says that FDA and industry have learned a lot in the last 10 years about the design, development, and production of high quality products
Devices
Retired CDRH branch chief Morris Waxler, who approved the original LASIK vision correction indication, is urging the Center to stop deceiving the public about adverse events (AE) associated with a laser procedure called the small incision lenticule extraction (SMILE) that is intended to reduce or eliminate nearsightedness in certain patients
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it embraces the collaborative approach FDA has taken towards identifying and mitigating drug shortages, including the open communication that the agency has fostered. In a comment on an agency 11/27/18 public meeting on drug shortages, PhRMA says it and its
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format.” The document is intended to assist NDA/ANDA holders with their submission of required marketing status notifications. To view the notice, click
Drugs
Federal Register notice: FDA has announced a 3/8 Microbiology Devices Panel meeting to discuss and make recommendations on new or alternative approaches to the clinical study design and evaluation of devices detecting human papillomavirus (HPV) nucleic acid. The approaches will take into consideration scientific data generated since the approval
Devices
FDA has extended its review of a Nuvectra PMA for its Virtis Sacral Neuromodulation system. “FDA has informed us that they have not yet concluded their review and as such will require an extension of our 180-day review period,” the company says. “To date, FDA has not identified any
Devices
FDA has cleared a XableCath 510(k) for its Peripheral Crossing Catheters, intended for use to cross challenging lesions in both arterial chronic total occlusions and chronic obstructive venous lesions. The device’s clearance is based on data demonstrating a 95% success rate in crossing arterial lesions and 100% success
Drugs
FDA has approved the first generic version of the GlaxoSmithKline Advair Diskus (fluticasone propionate and salmeterol inhalation powder) for twice-daily treatment of asthma in patients aged four years and older and maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease. The generic inhaler
Drugs
FDA has released a draft guidance entitled Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format. According to FDA, Section 506I imposes additional reporting requirements on NDA and ANDA holders, including: * Notification of withdrawal from sale, which requires NDA and ANDA holders
Drugs
Nature’s Rx has recalled its Silver Bullet 10x product because it was found to contain undeclared sildenafil and tadalafil, the active ingredient in Viagra and Cialis respectively, which are PDE-5 inhibitors. The undeclared ingredients may pose serious health risks because consumers with underlying medical issues may take the