Drugs
FDA has cleared a NeuroMetrix 510(k) for an upgraded version of Quell, the company's over-the-counter, drug-free chronic pain relief wearable device. The clearance covers the device’s controllability via the Quell Relief smartphone app. It also includes extended battery life and advanced sleep tracking.
Drugs
A Government Accountability Office report examining FDA’s expedited drug approval process in terms of postmarket drug safety found that “FDA lacks fundamental resources and leadership in ensuring that drugs brought to market quickly are truly safe and effective,” says Rep. Rosa DeLauro (D-CT), who requested the report. “If
FDA Policy/General
Federal Register Notice: FDA is establishing a docket to receive suggestions, recommendations, and comments from interested parties (including academic institutions, regulated industry, and patient groups) on its pilot “Clinical Outcome Assessment Compendium” (COA). Comments received on the pilot during its pilot phase will help FDA determine its utility, and may
Drugs
FDA is seeking public comment on its pilot Clinical Assessment Outcome (COA) Compendium, which the agency says is part of efforts to foster patient-focused drug development. “The COA Compendium is intended to facilitate communication and to provide clarity and transparency to drug developers and the research community by collating
Drugs
Hospira and Celltrion have filed a friend-of-the-court brief with the Federal Circuit Court of Appeals supporting Apotex in its dispute with Amgen over when commercial marketing of biosimilars may begin. The companies say that a lower federal court misread the provision in the Biologics Price Competition and
Drugs
FDA has granted Five Prime Therapeutics an orphan drug designation for FPA008 for treating pigmented villonodular synovitis (PVNS), a locally aggressive tumor of the synovium. The investigational antibody works by blocking the activation and survival of the macrophages that make up the bulk of the PVNS tumor. The rare tumor
Devices
FDA has cleared a Siemens Healthcare 510(k) for the Sysmex CS-5100 System, a hemostasis system that enables automated, standardized sample management as well as automated detection of unsuitable samples. The company says it’s the first analyzer in its hemostasis solutions portfolio equipped with “simultaneous multi-wavelength Preanalytical
Drugs
CDER’s online learning portal, CDERLearn, has added two educational tutorials on generic drug user fee “self identification” electronic (SPL) submissions. The courses offer a comprehensive review of the required data elements and their restrictions for the Self-Identification SPL file. They also guide firms through the successful submission process,
Devices
Recent drug company court victories (see earlier story) against FDA involving First Amendment challenges over off-label promotion did not motivate medical device maker LED Medical to fight a 5/2014 Warning Letter citing certain marketing verbiage on the company’s Web site pertaining to its VELscope Vx system. The
Devices
Attorney Michelle Yeary (Dechert) says a Texas federal court recently rejected a whistleblower’s argument that because FDA has not determined the safety and effectiveness of off-label use of biliary stents used in a vascular stenting procedure, Medicare payment claims for the stents were false. Essentially, she writes in
FDA Policy/General
A PwC Health Research Institute analysis projects that the healthcare spending growth rate for 2016 will be 6.5%, down from the 6.8% in 2015. The report identifies three factors that “deflate” the medical cost trend in 2016: the looming Affordable Care Act “Cadillac” tax accelerates cost shifts, virtual
FDA Policy/General
Several Wilson Sonsini attorneys say they expect FDA to begin regulating high-risk laboratory-developed tests (LDTs) early this year. Writing in an online blog post, they say this move will be contentious and that they expect court challenges to the agency’s regulation. “FDA’s regulation of LDTs has
Drugs
FDA has published safety labeling changes for 31 products approved 12/2015, including revised Warnings and Precautions for five multiple sclerosis drugs for cases of thrombotic microangiopathy — Biogen’s Avonex (interferon beta 1a), Bayer’s Betaseron (interferon beta 1b), Novartis’ Extavia (interferon beta 1b), Biogen’s Plegridy (peginterferon beta 1a)
Devices
CDRH has announced its three strategic priorities for 2016-2017 — establish a National Evaluation System for medical devices; partner with patients; and promote a culture of quality and organizational excellence. The Center says the national medical device evaluation system will “build upon and leverage the vast amount of information and
Devices
FDA has planned a 1/21 Webinar for industry to review a recently released guidance on “Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings.” The guidance describes regulatory requirements and the performance testing needed to support liquid barrier claims for such. It discusses performance standards established
Devices
A report prepared by the Democratic staff of the Senate HELP Committee blasts Olympus and other duodenoscope manufacturers and FDA for cleaning problems with closed-channel duodenoscopes that sickened at least 250 patients worldwide in at least 25 different incidents of antibiotic-resistant infections between 2012 and spring 2015. The
Drugs
Senate Health, Education, Labor and Pensions Committee chair Lamar Alexander (R-TN) says his committee is still planning to move forward its biomedical innovation/FDA reform bill despite the fact that it is a presidential election year. In remarks made before the HELP committee voted on Robert Califf’s nomination
FDA Policy/General
Federal Register Notice: FDA is seeking public comment on regulations restricting the sale and distribution of cigarettes and smokeless tobacco to protect children and adolescents. Comments should be submitted by 3/14. To view this notice, click here.
Devices
An 8/5-8/11/15 FDA inspection at ARB Medical, Minneapolis, MN, found multiple Quality System Regulation violations in the firm’s manufacturing of polymeric surgical meshes. A 12/22/15 Warning Letter from the agency’s Minneapolis District Office says that violations included: failing to adequately validate, according
Drugs
The U.S. Supreme Court rejected 1/11 a petition filed by Ortho-McNeil-Janssen asking it to review a South Carolina Supreme Court decision that imposed a $124 million civil penalty against Janssen for a “Dear Doctor” letter it sent involving the label for its Risperdal (risperidone) anti-psychotic
Drugs
CDER has denied an 8/3/15 Supernus Pharmaceuticals petition asking that the agency require specific partial area under the plasma concentration-time curve bioequivalence parameters to govern the review and approval of any ANDA referencing Oxtellar XR (oxcarbazepine) as the reference-listed drug. The denial letter says that while
Drugs
AbbVie says it would like more information from FDA on how it plans to enforce the United States Pharmacopeia (USP) salt policy for those products in development between 5/1/13 when the policy became effective and the final issuance of an FDA draft guidance on naming of drug products