FDA Policy/General
Draft Guide on Rare Diseases with Substrate Deposition Federal Register notice: FDA makes available a draft guidance entitled “Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition that Results from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies.” 07/27/2018 Guide on Certain Pediatric Orphan
Drugs
FDA has issued INSYS Therapeutics a complete response letter for its buprenorphine sublingual spray as a treatment for moderate-to-severe acute pain. The letter adheres to an advisory committee vote in May and “indicates that, although the clinical development program demonstrated all three proposed doses of the product candidate
Devices
FDA has cleared a Cepheid 510(k) for the Xpert Xpress Flu/RSV test, which can be performed in near-patient settings, providing rapid molecular detection of influenza A and B viruses, and respiratory syncytial virus from patient specimens within 20 minutes. In addition to nasopharyngeal swab specimens, the test
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition that Results from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies.” The document applies only to diseases with a well-characterized pathophysiology and in which changes
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases.” The agency says it does not expect to grant any additional orphan-drug designations to drugs for pediatric subpopulations of common diseases (i.e., diseases
Devices
FDA has cleared a LifeSignals 510(k) for its wireless LP1100 Life Signal Patch that is intended for enabling the next generation of wearable, healthcare monitoring devices. It uses the company’s recently launched LC100 Life Signal Processor platform and a patented, integrated multi-electrode architecture, according to the company.
FDA Policy/General
Federal Register notice: FDA has announced the fiscal year 2019 rates for generic drug program areas. For FY 2019, rates are: ANDA ($178,799), Drug Master File ($55,013), domestic Active Pharmaceutical Ingredient (API) facility ($44,226), foreign API facility ($59,226), domestic Finished Dosage Form (FDF) facility ($211,305)
FDA Policy/General
Federal Register notice: FDA has released a draft guidance entitled “Peripheral Vascular Atherectomy Devices — Premarket Notification [510(k)] Submissions.” The guidance encourages industry to engage CDRH under its pre-submission process to obtain feedback based on device indications and operational characteristics. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has determined that metaxalone tablets, 640 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve ANDAs that reference the product if all other legal and regulatory requirements are met. The determination was made in response to
Devices
FDA has cleared an Adherium 510(k) for its Hailie sensor and its use with Teva’s ProAir HFA, and GlaxoSmithKline’s Ventolin HFA and Flovent HFA asthma inhalers. The device attaches to a patient’s asthma medication inhaler to monitor and promote adherence as part of a self-management
Drugs
FDA has published a draft guidance, Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition That Results from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies, to give guidance to sponsors on the evidence necessary to demonstrate the effectiveness of new drugs or new drug uses
Drugs
CDER director Janet Woodcock and CDER Office of Pharmaceutical Quality director Michael Kopcha say FDA has responded to stakeholder requests for continued dialog on quality metrics with two new voluntary programs. Writing in an FDA Voice blog post, the two say that the programs are the Quality Metrics Feedback Program
Devices
FDA has cleared a CarboFix 510(k) for the CarboClear Carbon Fiber Pedicle Screw System, a device intended to surgically treat oncological patients. The device is intended to restore the integrity of the spinal column in the absence of fusion for a limited time in patients with advanced-stage tumors
Drugs
Regulatory consulting firm Greenleaf Health has added former FDA field investigator Kristen Grumet as senior vice president for regulatory compliance. Grumet spent almost 10 years at the agency and focused on medical device compliance. She also has 16 years of quality systems compliance management and consulting within the device industry.
Drugs
Attorney Jennifer Davidson (Kleinfeld, Kaplan & Becker) says an FDA 7/18 draft question-and-answer guidance on field alert report (FAR) submissions clarifies the circumstances under which a FAR should be submitted. FDA regulations says a FAR should be submitted to the agency within three working days of receipt
Drugs
FDA says it has finalized a guidance, Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases. A Federal Register notice scheduled to be published 7/27 says the agency does not expect to grant any additional orphan drug designation to drugs for pediatric subpopulations of
Devices
FDA has released a draft guidance entitled “Peripheral Vascular Atherectomy Devices — Premarket Notification [510(k)] Submissions.” The document says that atherectomy devices vary in design and complexity and there are currently four main categories. The choice of an atherectomy device depends on plaque location, vessel characteristics, length of disease segment,
Biologics
FDA has told ADMA Biologics that it has closed out an April Establishment Inspection Report (EIR) issued after a compliance inspection at the firm’s Boca Raton, FL production facility. The EIR cited requests for clarification and information, as well as a summary of potential next steps for the review
Devices
The Justice Department says AngioDynamics will pay the U.S. $12.5 million to resolve allegations that it caused healthcare providers to submit false claims to Medicare, Medicaid, and other federal healthcare programs relating to use of its LC Bead and Perforator Vein Ablation Kit (PVAK) medical devices. A department
Drugs
FDA’s Pulmonary Allergy Drugs Advisory Committee has voted 16 to 3 against approving the use of GlaxoSmithKline’s mepolizumab as an add-on treatment to inhaled corticosteroid-based maintenance treatment for reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) guided by blood eosinophil counts. The committee said
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Permanent Discontinuation or Interruption in Manufacturing of Certain Drug and Biological Products — 21 CFR 310.306, 314.81(b)(3)(iii), and 600.82” (OMB Control Number 0910-0759). FDA regulations require manufacturers to provide notice of
Drugs
Public Citizen says FDA and the HHS Office for Human Research Protections (OHRP) should immediately investigate two prospective clinical trials in Minnesota that involved testing the general anesthetic ketamine and powerful sedatives on patients without their consent. The advocacy group was joined by 64 doctors, bioethicists, and academics in the