Devices
FDA has cleared an Intuitive Surgical 510(k) for an integrated operating table motion claim for the da Vinci Xi Surgical System. Integrated table motion combines the da Vinci robotic-assisted surgical system and Trumpf Medical’s advanced operating table, the TruSystem 7000dV, to allow surgeons and anesthesiologists the ability
Drugs
FDA has approved Allergan’s Botox (onabotulinumtoxinA) for treating lower limb spasticity in adult patients to decrease the severity of increased stiffness in ankle and toe muscles. The drug was first approved in 2010 for treating upper limb spasticity (ULS), or increased muscle stiffness in the elbow, wrist and fingers.
Drugs
United Therapeutics has petitioned FDA urging it to require strict bioequivalence standards for generic copies of its Tyvaso (treprostinil) inhalation solution. Tyvaso is a drug-device combination product indicated for treating pulmonary arterial hypertension in patients with specific symptoms to increase walk distance. The petition, filed by the law firm
Drugs
FDA has approved an Amgen supplemental NDA for Kyprolis (carfilzomib) for injection in combination with dexamethasone or with lenalidomide plus FDA has approved an Amgen supplemental NDA for Kyprolis (carfilzomib) for injection in combination with dexamethasone or with lenalidomide plus dexamethasone for treating patients with relapsed or refractory multiple myeloma
Drugs
FDA says it is “conferring” with European regulators after a Phase 1 trial, conducted by French clinical research organization Biotrial, resulted this week in the death of one enrolled patient and neurological injury to four others. The study involved Portuguese company Bial’s BIA 10-2474 and its use in
Drugs
FDA has granted Cellceutix Corp. an orphan drug designation for kevetrin for treating pancreatic cancer. The designation was based on data from a Phase 1 trial involving one patient who was administered the therapy once weekly for three weeks with an off-week between cycles. The patient, who was diagnosed
Drugs
FDA has approved an Allergan supplemental NDA to update the label for Dalvance (dalbavancin) for injection to include a single dose administered as a 30-minute intravenous (IV) infusion for treating acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible Gram-positive bacteria in adults, including infections
Drugs
FDA approved last year Aprecia Pharmaceutical’s Spritam (levetiracatam) as the “first 3D printed drug product.” Attorney Jesse Salen (Sheppard Mullin Richter & Hampton) cites the approval in an online blog post as an example of how the patentable life of 3D printers can be extended. Spritam is indicated to
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act — 21 U.S.C. 379aa-1(b)(1),” has been submitted to the Office of Management and Budget (OMB) for review
FDA Policy/General
Federal Register Notice: FDA is providing notice that the conditional approval of an application for masitinib mesylate tablets, a new animal drug for a minor use, is no longer in effect as of 12/15/15. Because of this Kinavet-CA1 tablets are now an unapproved new animal drug product
FDA Policy/General
Federal Register Notice: FDA has determined that 12 drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
FDA Policy/General
Federal Register Notice: FDA is making available a guidance entitled Implanted Blood Access Devices for Hemodialysis. It was developed to support the reclassification of the implanted blood access devices for hemodialysis into Class 2 (special controls) and to assist industry in preparing premarket notification (510(k)) submissions for implanted blood
FDA Policy/General
Federal Register Notice: FDA is making available a guidance entitled Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile. It updates and clarifies the information on sterilization processes that FDA recommends sponsors include in 510(k)s for devices labeled as sterile.
FDA Policy/General
Federal Register Notice: FDA’s Cellular, Tissue and Gene Therapies Advisory Committee will meet 2/16 from 1 p.m. to 5 p.m. at FDA White Oak Conference Center, Rm 1503. The committee will meet by teleconference. In open session, the committee will hear updates of research programs in
FDA Policy/General
Federal Register Final order: FDA is classifying the tympanic membrane contact hearing aid into Class 2 (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the tympanic membrane contact hearing aid’s classification. To
Drugs
CDER director Janet Woodcock says that the successful transformation of the Center’s generic drug program and moving it to a very high level of productivity was CDER’s top success in 2015. Speaking in a Director’s Corner podcast, she said the changes involved a new information technology platform
Devices
FDA has cleared a Centinel Spine 510(k) for the ALTOS posterior cervical thoracic stabilization system indicated for use in either the lateral masses of the cervical spine or the pedicles of the cervical-thoracic spine The low profile, stabilization system offers both fully threaded and smooth shank polyaxial screws
Drugs
FDA has issued an import ban against China’s Zhejiang Hisoar Pharmaceutical Co. for all drug products produced at its Taizhou City manufacturing plant due to GMP deviations. An agency inspection in August found that quality records had been deleted and test records were altered, according to a Bloomberg report.
FDA Policy/General
The 9th Circuit Court of Appeals says that a California federal court erred in granting the federal government’s motion to compel production of many attorney-client documents as part of an obstruction of FDA case involving 1-800-Get-Thin, a weight loss call center that marketed the LapBand
Drugs
FDA has accepted a Collegium Pharmaceutical IND application to begin a clinical trial of Hydrocodone DETERx, an abuse-deterrent, extended-release analgesic for treating chronic pain. The company says the trial aims to evaluate the safety, bioavailability, and abuse deterrence properties of Hydrocodone DETERx. It adds that the microsphere-in-
FDA Policy/General
Federal Register Notice: FDA has determined that Mevacor (lovastatin) tablets, 20 mg and 40 mg, were not withdrawn from sale for reasons of safety or effectiveness. This will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
FDA Policy/General
Federal Register Notice: FDA is making available a guidance for industry entitled Target Animal Safety Data Presentation and Statistical Analysis. Its purpose is to provide recommendations to industry on the presentation and statistical analyses of target animal safety (TAS) data submitted to the Center for Veterinary Medicine as part of