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
Drugs
FDA has issued a guidance, Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products, to encourage manufacturers of medically necessary drug products and any components of those products to develop contingency production plans to use during emergencies that result in high absenteeism at production
Devices
The Healthcare and Public Sector Coordination Council Joint Cybersecurity Working Group, of which FDA is a member, has produced a Joint Security Plan (JSP) to address cybersecurity challenges in using software-based medical technologies. The document says the challenges include but are not limited to transparency and disclosure between vendors
Drugs
FDA commissioner Scott Gottlieb says the agency is developing a pilot program to help patients navigate the expanded access protocol to receive access to drugs that have not yet been approved. Speaking on a wide-ranging American Society of Clinical Oncology podcast, Gottlieb said the pilot will enable agency personnel
Drugs
FDA has granted Merck a breakthrough therapy designation for its V114 investigational 15-valent pneumococcal conjugate vaccine, indicated for preventing invasive pneumococcal disease (IPD) caused by the vaccine serotypes in pediatric patients 6 weeks to 18 years of age. V114 is also under development for preventing IPD in adults. Both
Drugs
FDA commissioner Scott Gottlieb says the agency is taking steps to “ensure that the Orange Book provides the greatest benefit to patients and providers, and generic drug developers. We want to make sure it provides as much utility as possible to aid manufacturers as they allocate resources towards the development
Devices
FDA has approved a Kurin 510(k) for its Kurin PIV18 peripheral IV (PIV) configuration with an extension set, which is intended for use with infusions. Many blood cultures are taken via direct venipuncture. By adding an extension set to a previously-available PIV product, nurses can leave the set
Drugs
Tris Pharma has recalled three lots of infants’ ibuprofen concentrated oral suspension, 50 mg per 1.25 mL, because the products have been found to potentially have higher concentrations of ibuprofen. “There is a remote possibility that infants, who may be more susceptible to a higher potency level of drug,