Drugs
FDA has granted Abeona Therapeutics a fast track designation for ABO-202, a novel one-time AAV9 gene therapy for CLN1 disease. The therapy is designed to deliver a functional copy of the PPT1 gene to the central nervous system and peripheral organs using a combination of intravenous and intrathecal
Devices
FDA has cleared a Life Spine 510(k) for the Prolift Lateral Expandable Spacer System for use in treating spinal disorders. The device, which is available in several lordotic options, allows for post-packing in situ, has anatomically convex endplates and is made using Life Spine’s proprietary Osseo-Loc
Drugs
The Association for Accessible Medicines (AAM) says it supports the administration’s decision not to include pharmaceuticals and certain pharmaceutical inputs on the most recent list of Chinese exports that would face U.S. tariffs when imported into this country. In a letter to U.S. trade representative Robert Lightizer,
Drugs
FDA has granted Merck accelerated approval for Keytruda (pembrolizumab) and its use in treating patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. The anti-PD-1 therapy’s approval was based on tumor
Drugs
A 5/12-5/30/18 FDA inspection at the Tropical Seas drug manufacturing facility in Holly Hill, FL, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A just-released 5/15 Warning Letter also says the firm produces several products that the agency considers
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Data to Support Social and Behavioral Research as Used by the Food and Drug Administration” (OMB Control Number 0910-0847). The agency says that understanding patients, consumers, and healthcare professionals’ perceptions and behaviors plays an important role
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “FDA Postmarket Surveillance of Medical Devices — 21 CFR Part 822” (OMB Control Number 0910-0449). FDA’s regulations authorize it to require a manufacturer to conduct postmarket surveillance (PS) of any device that meets the criteria set
Devices
Cook Medical has recalled its Advance Enforcer 35 Focal-Force PTA Balloon Catheter (6mm x 4cm) after multiple complaints were received about balloons bursting below the rated burst pressure. The company says that while there have been no reports of malfunctions, deaths, or injury reported for the balloon issue, there
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. PRL, Inc. Lobelville, TN (6/6): FDA inspected the firm 10/2018 and cited multiple serious GMP violations for dietary supplements. The letter also says the agency collected labels
Drugs
FDA scientists say they have developed a poliovirus assay that is faster and more versatile than those now used to monitor polio vaccine production, assess patient responses to polio vaccines during clinical trials, and do environmental surveillance of vaccine poliovirus. They say the new assay also is the first to
Drugs
Researchers from Harvard Medical School and the University of Calgary say there are similar development times for small molecules and biologic drugs, leading to questions about the longer patent period under the Biologics Price Competition and Innovation Act. “Our study reviewed pre-market times for all new drugs approved by
Devices
Department of Homeland Security’s National Cybersecurity and Communications Integration Center has issued a cybersecurity alert on BD’s Alaris Gateway Workstation, which is used to integrate infusion pump systems with hospitals’ central clinical information systems. The cyber threat could “allow unauthorized arbitrary code execution, which could allow an attacker
Drugs
A just-posted article in BMC Medicine finds that about half of studies FDA requires in post-marketing commitments are ever published in peer-reviewed journals. “Postmarketing commitments are studies that drug companies agree to conduct at the time of FDA approval, and are not required by statute or regulation,
Drugs
Sen. Bernie Sanders (I-VT) and Rep. Elijah E. Cummings (D-MD) are urging the Justice Department to investigate 20 generic drug manufacturers for allegedly engaging in a price-fixing scheme. “It is sick and disgraceful that generic pharmaceutical executives, who should be making medicines affordable for the American people,
Devices
FDA has granted Bio-Techne a breakthrough device designation for its ExoDx Prostate IntelliScore test, which the company says is the first exosome-based liquid biopsy test to receive such a designation. The breakthrough program is designed to expedite the development, assessment and review of certain devices through interactive and
FDA Policy/General
Federal Register notice: FDA is requesting that any industry organizations interested in participating in selecting nonvoting industry representative to serve on CBER’s Allergenic Products Advisory Committee notify FDA in writing. The agency is also requesting nominations for nonvoting industry representatives to serve on the committee. To view the notice,
Devices
FDA has approved Cochlear Limited’s new Cochlear Nucleus Profile Plus Series Cochlear Implant and the Nucleus 7 Sound Processor’s new built-in connectivity featuring direct streaming with compatible Android smartphones. The device is designed for safe access to magnetic resonance imaging scans without the need to remove the
Drugs
FDA has granted NuCana an orphan drug designation for its investigational drug, Acelarin (NUC-1031), and its use in treating biliary tract cancer. The company describes the new chemical entity as its “ProTide transformation of gemcitabine... Our Phase 1b study of Acelarin combined with cisplatin showed an approximate doubling of
Drugs
FDA has approved an expanded use for Novo Nordisk’s Victoza (liraglutide) for improving blood sugar control in pediatric patients with Type 2 diabetes. “Victoza improves blood sugar levels by creating the same effects in the body as the glucagon-like peptide (GLP-1) receptor protein in the pancreas,” an
FDA Policy/General
Testing for Biotin Interference in IVDS Federal Register notice: FDA makes available a draft guidance entitled “Testing for Biotin Interference in In Vitro Diagnostic Devices.” 06/14/2019 FDA Withdraws 12 No-longer Marketed ANDAs Federal Register notice: FDA withdraws approval of 12 ANDAs from multiple applicants after they notified
FDA Policy/General
Advanced Botanical Consulting and Testing, Tustin, CA (6/4): FDA inspected the contract testing laboratory 11/2018 and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods. FDA said it did not use
FDA Policy/General
DEVICES FDA has cleared an AnthroTronix 510(k) for its computerized cognitive test battery DANA, which is intended to provide clinicians with objective measurements of reaction time (speed and accuracy) to aid in the assessment of an individual’s medical or psychological state. The phone and tablet based app is