Devices
FDA and the medical device industry have reached an agreement in principle on the next round of user fees that will see fees skyrocket by about $400 million (67%) over the next five years beginning 10/1/2017. This is the fourth reauthorization of the medical device user fee program,
Devices
FDA has published a guidance, Patient Preference Information — Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling, explaining the principal concepts for sponsors and other stakeholders to consider when choosing to collect patient preference information (PPI)
Devices
FDA is proposing to amend the good laboratory practice (GLP) regulations for non-clinical laboratory studies to require a GLP Quality System approach when safety and toxicity studies support or are intended to support applications or submissions for FDA regulated products. A Federal Register notice says the agency also is
Devices
An FDA inspection at Tosoh Bioscience, Grove City, OH, on various dates between 5/16 and 6/28 found Quality System Regulation violations in the firm’s work as the initial importer, complaint handling unit, and repacker/relabeler of high performance liquid chromatographs used in measuring hemoglobin, automated immunoassay analyzers
Drugs
Stakeholders are expressing general support for a PDUFA 6 commitment letter released by FDA for comments. The American Medical Informatics Association (AMIA) says the letter’s references to evidence generation and several recent guidances “signal clear interest by the agency to leverage informatics tools and methodologies to augment regulatory decision-
Drugs
FDA has granted Vaccinex an orphan drug designation for its therapeutic monoclonal antibody VX15, which is currently being investigated in a Phase 2 clinical trial (SIGNAL) for treating Huntington’s disease (HD). The company says the SIGNAL trial is based on prior research involving neurodegenerative disease mechanisms, where it was
Devices
FDA has posted a final guidance on “Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications” that outlines the principal factors it considers when making such determinations during the premarket review process for certain medical devices. The document is intended to improve
Drugs
FDA has accepted for priority review a Clovis Oncology NDA seeking accelerated approval for rucaparib and its use in treating advanced ovarian cancer in patients with deleterious BRCA-mutated tumors inclusive of both germline and somatic BRCA mutations (as detected by an FDA-approved test) and who have been treated
Drugs
Lilly has petitioned FDA asking that the agency refuse to approve any ANDA citing its Forteo (teriparatide [rDNA origin] injection) as the reference-listed drug or reference product, including a specific Teva ANDA. The petition also asks the agency to require that any 505(b)(2) NDA applicant or future
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Cape Apothecary, Inc. Annapolis, MD (8/12). Unapproved new drugs, adulterated, misbranded: The drug products that the firm manufactures and distributes without valid prescriptions for individually-identified patients are
Drugs
FDA has approved in part and denied in part a Cubist Pharmaceuticals 5/7/15 petition asking that it refuse to accept for filing, for substantive review, or for approval any ANDA or 505(b)(2) NDA referencing Cubist’s Dificid (fidaxomicin) 200 mg film-coated tablets that does not
Devices
FDA has classified as Class 1 a recall involving Alere’s INRatio 2 PT/INR Home Monitoring System for warfarin therapy. Last month, the company said it was initiating a voluntary withdrawal of its controversial device due to concerns about inaccurate test results. Last year, Public Citizen reported that the
Drugs
FDA has approved a Pfizer NDA for Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride) extended-release capsules, indicated for treating pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The approval covers the drug’s properties that are
Drugs
FDA has extended by three months its review of a Sanofi NDA for iGlarLixi (insulin glargine and lixisenatide) injection, indicated for improving glycemic control in adults with Type 2 diabetes mellitus. Sanofi has submitted updated information on the pen delivery device to address concerns from an advisory committee that reviewed
Devices
FDA’s newly issued draft guidance that updates recommendations on when device makers need to submit a new 510(k) after making device modifications has special meaning to lawyers representing companies in product liability lawsuits, according to Reed Smith lawyer James Beck. In a new blog post, Beck welcomes the
Devices
FDA has approved an ImPACT Applications de novo petition to allow the marketing of two new devices to assess a patient’s cognitive function immediately after a suspected brain injury or concussion. The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric are the first medical devices approved
Drugs
FDA has granted Eli Lilly and AstraZeneca a fast track designation for AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in Phase 3 clinical trials for treating Alzheimer’s. In addition to the AMARANTH phase 2/3 study, the companies says they will begin a second Phase 3
Drugs
Honeywell has recalled one lot of its 32-ounce Eyesaline Eyewash solution, which is used for emergency eye rinsing after an injury, because of product contamination concerns. A recall notice says that while no contamination was detected in its batch testing, the recall is a precautionary measure due to a
FDA Policy/General
Kindred Biosciences has submitted the effectiveness technical section of a New Animal Drug Application for Mirataz (mirtazapine transdermal ointment) that seeks an indication for managing weight loss in cats. The chemistry, manufacturing, and controls technical section was submitted in May, and the company plans to submit the safety technical section
Drugs
DEVICES FDA has cleared an Alere 510(k) for its Alere i RSV test for detecting respiratory syncytial virus infection in children and adults. Results for the test are obtained in 13 minutes or less. It works by testing swab samples using Alere’s Molecular In Minutes isothermal nucleic acid
FDA Policy/General
BIOLOGICS CBER Advisory Panel to Hear Research Updates Federal Register Notice: FDA’s Allergenic Products Advisory Committee will meet 10/27, from 1 p.m. to 4:20 p.m. at FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring,
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information “Mammography Quality Standards Act Requirements — 21 CFR Part 900,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. To view this notice, click here.