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
Devices
FDA has cleared an OptMed Inc. 510(k) for its BondEase product, a topical skin adhesive intended for the closure of surgical incisions and lacerations as an alternative to sutures and staples. The biocompatible, topical skin adhesive combines a novel polymer technology with a user-friendly delivery device, according to
FDA Policy/General
The law firm Ballard Spahr has hired Neil P. DiSpirito, an attorney with more than 20 years of experience advising pharmaceutical, medical device, and life sciences clients on compliance with U.S. pharmaceutical, biologic, and medical device regulation. Previously, he was an attorney at Olsson Frank Weeda. DeSpirito also teaches
Devices
Thornhill Research has begin a Class 1 recall of its Moves Ventilator lithium polymer batteries because some have been found unresponsive after storage, not recognized by the main device, and perpetually enabled, according to a recall notice. The portable, computer-controlled transport emergency ventilator is intended to provide continuous or
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Advantage Biosciences, Inc. Newport Beach, CA (12/17/15). FDA reviewed the firm’s product labeling and its Web site at ww.resvantage.com Unapproved new animal drugs, adulterated.
FDA Policy/General
Federal Register Notice: FDA will hold a public workshop 2/25 entitled “Next Generation Sequencing-Based Oncology Panels.” Its purpose is to obtain feedback on analytical and clinical validation approaches for such panels. Comments and suggestions generated through this workshop will help guide the development of appropriate regulatory standards for