Drugs
Continued government losses in lower courts involving First Amendment-related off-label drug marketing cases raise the specter that FDA’s entire pre-market approval regime could be in jeopardy, according to University of Arizona law professor Christopher Robertson. Writing in an Arizona Legal Studies discussion paper, Robertson notes how
Devices
FDA has posted a draft guidance on “Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI)” that defines the expected content and forms to assist both labelers and FDA-accredited issuing agencies. The document is intended to ensure the UDI issuers are in compliance with the
Drugs
FDA has lifted a clinical hold affecting a Novartis/GenVec Phase 1-2 clinical trial of CGF166 in patients with severe to profound hearing loss. In January, Novartis told GenVec that enrollment in the trial had been stopped in accordance with criteria in the trial’s protocol. In April, Novartis
Devices
Carefusion has recalled certain lots of its Diamond-Flex Circular Retractor, Angled, 40mm and 5mm devices. A recall notice says the firm identified a potential risk associated with a weld failure which could result in the wire protruding through the tip of the instrument when articulated. If this failure were
Drugs
Deficiencies cited during a preapproval inspection at an Ocular Therapeutix manufacturing facility has led to a FDA complete response letter for its NDA on Dextenza (dexamethasone insert) 0.4 mg, for intracanalicular use in treating ocular pain occurring after ophthalmic surgery. The letter raised concerns pertaining to unspecified deficiencies in
FDA Policy/General
BIOLOGICS Workshop on Pre-clinical Evaluation of Red Blood Cells Federal Register Notice: FDA will hold a public workshop 10/6-7 entitled “Pre-Clinical Evaluation of Red Blood Cells for Transfusion.” Its purpose is to discuss new methodologies for pre-clinical evaluation of the safety and efficacy of red
FDA Policy/General
DEVICES FDA has approved an Asuragen de novo submission to allow marketing of the QuantideX qPCR BCR-ABL IS Kit, the first nucleic acid-based quantitation test for use during treatment of chronic myeloid leukemia (CML) patients. The device uses blood specimens from patients with CML to measure the amount
FDA Policy/General
Chronos Therapeutics has acquired three pre-clinical development programs targeting central nervous system diseases from a subsidiary of Shire. Chronos has acquired all intellectual property, know-how, development and marketing rights for each program, and Shire becomes a strategic equity investor in Chronos and is eligible for milestone payments on
Drugs
FDA has given Valeant Pharmaceuticals a complete response letter on its NDA for latanoprostene bunod ophthalmic solution, 0.024%, an intraocular pressure lowering single-agent eye drop for patients with open angle glaucoma or ocular hypertension. The agency’s letter cited GMP deficiencies documented during a preapproval inspection at Bausch
Devices
Johnson & Johnson subsidiary Acclarent has agreed to pay $18 million to settle a federal whistleblower false claims lawsuit alleging that the company marketed a sinus device for a drug delivery use not approved by FDA, and causing healthcare providers to submit false claims to Medicare and other healthcare programs.
Devices
FDA has classified as Class 1 a Stryker Sustainability Solutions (formerly Ascent Healthcare Solutions) recall involving its Flush Angiographic Catheter due to tip separation. The device is used to inject contrast dye into blood vessels in preparation for a cardiac angiogram. The recall was ordered due to reports about the
Devices
FDA’s Clinical Chemistry and Clinical Toxicology Devices Panel voted 8 to 2 to support approval for Dexcom’s G5 Mobile continuous glucose monitoring system and its use as a replacement for fingerstick glucose monitoring in patients with diabetes. Currently, the device is indicated for adjunctive use along with self-
Devices
FDA has approved an Asuragen de novo submission to allow marketing of the QuantideX qPCR BCR-ABL IS Kit, the first nucleic acid-based quantitation test for use during treatment of chronic myeloid leukemia (CML) patients. The device uses blood specimens from patients with CML to measure the amount of
FDA Policy/General
FDA comes under stringent criticism in the GOP Platform 2016 adopted during the Republican National Convention that concluded in Cleveland, OH 2/22. Pledging to reform the agency, the document says FDA is now threatening “America’s leadership in life sciences R&D and medical innovation” through a “lack
Biologics
FDA has asked Merck to submit new data and analyses from the clinical trials MODIFY I and MODIFY II that support a pending BLA for bezlotoxumab, an investigational agent for preventing Clostridium difficile (C. difficile) infection recurrence. The additional data and analyses will be considered a major amendment, resulting in
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for NeurogesX, Inc.’s Qutenza (capsaicin) is 2,944 days for extending a patent that claims the human drug product. Qutenza is indicated for managing neuropathic pain associated with postherpetic neuralgia. To view this notice, click here.
FDA Policy/General
Federal Register Direct final rule: FDA is confirming the effective date of 8/17 for the direct final rule that appeared in the 4/4 Federal Register amending the regulations describing lesser administrative actions that may be imposed on an Institutional Review Board that has failed to comply with applicable
Devices
FDA has approved a Vasorum Ltd. PMA for the Celt ACD vascular closure device, indicated for arterial puncture closure in both diagnostic and anticoagulated percutaneous interventional cardiology and radiology patients. The device comes in three sizes for safe and effective closure of 5F, 6F and 7F punctures. It was “designed
Devices
FDA has cleared a Relievant Medsystems 510(k) for the Intracept Intraosseous Nerve Ablation System for relieving chronic low back pain that has not responded to at least six months of conservative care and was caused by changes associated with degeneration of spinal vertebral bodies and the nearby intervertebral discs.
Drugs
The HHS Inspector General says that FDA is issuing more postmarketing study requirements (PMRs) to drug sponsors but continues to have problems with its data management system and work processes, which hinder its ability to track those requirements. The report says that in 2006 the Inspector General found that the
Drugs
Now that CDER reviewers are accompanying ORA investigators as part of the drug preapproval inspection team, some of the questions being asked during the inspections are seeking answers to issues typically communicated in NDA/BLA/ANDA review “information request” letters. This was a complaint raised during a Pharmaceutical Quality Symposium
Drugs
Attorney Nathan Beaver (Foley & Lardner) says that FDA is unlikely to implement a biosimilar approval process laid out by the Federal Circuit Court of Appeals in Amgen v. Apotex. In an online National Law Review post, Beaver says that the court interpreted a provision in the Biologics Price Competition