Drugs
FDA has placed on clinical hold a Cara Therapeutics adaptive pivotal trial of I.V. CR845 for postoperative pain pending a pre-specified safety review. “A protocol-specified stopping rule, based on elevated serum sodium levels greater than 150 mmol/L, was met during the first phase of the study,
FDA Policy/General
Viruxo, a Florida dietary supplement distributor, has been ordered by a federal court to stop selling its product, which it claimed could treat herpes. The order came in a consent decree of permanent injunction between FDA and James R. Hill, doing business as Viruxo LLC. The complaint also included a
Devices
The 9th Circuit Court of Appeals has affirmed a California federal court award of summary judgment to Masimo Corp. throwing out a whistleblower suit brought by three former company sales representatives. The whistleblowers had contended that the company violated the False Claims Act by failing to inform FDA that clinical
Devices
FDA has cleared an APN Health 510(k) to market Navik 3D, a cardiac mapping system that is designed to reduce the cost and complexity of electrophysiology procedures. The device is intended to give cardiologists real-time 3D catheter location in the heart from 2D fluoroscopic images and correlate them
FDA Policy/General
University of Miami professor Crystal Adams says it appears that drug manufacturers using Internet banner ads for prescription drugs are trying to comply with FDA ad guidelines that are not really applicable. In the absence of specific guidelines for banner ads, she writes online in the Journal of Medical Internet
Devices
FDA has issued a safety alert on neurosurgical head holders based on medical device reports associated with the slippage or movement of a skull clamp before or during surgical procedures, resulting in more than 700 injuries. device used to secure the patient’s head position during surgical procedures. The system
Devices
At a 1/27 MDUFA 4 reauthorization meeting, FDA presented an integrated proposal combining elements of industry and agency proposals on several topics. Meeting minutes indicate that the agency presented additional details on certain aspects of the proposal and discussed each topic’s importance. Industry agreed to consider the proposal
Drugs
It hit like a bolt out of the blue. Delivered 2/4 with all the urgency of UPS Next Day Air, the five-page FDA Warning Letter told Myerlee Pharmacy owners Jeffrey Steele and Milton Larrea they had 15 working days to notify Florida District Office “of the specific steps
Drugs
House Appropriations Subcommittee on Agriculture chairman Robert Aderholt (R-AL) balked 2/25 at FDA’s proposed $202 million increase in new user fees for FY 2017. During a budget subcommittee hearing, Aderholt said that while there is a time and place for user fees as demonstrated by the success
FDA Policy/General
Federal Register Notice: FDA and the Foundation for the National Institutes of Health Biomarkers Consortium (FNIH BC) will hold a public workshop 4/14-15 entitled “Developing an Evidentiary Standards Framework for Safety Biomarkers Qualification Workshop.” Its purpose is to discuss the evidentiary standards needed to support biomarker qualification with
Drugs
As part of President Obama’s 2015 Precision Medicine Initiative (PMI), the National Institutes of Health says it is building a national, large-scale, research participant group known as a PMI cohort that will seek to extend precision medicine to all diseases by building a national research cohort of one
Drugs
CDER Office of Generic Drugs (OGD) director Kathleen Uhl says that OGD is meeting all of its obligation under the GDUFA commitment letter. In a 2/23 slide presentation to the Generic Pharmaceutical Association annual meeting, she said that OGD is “going above and beyond the commitments” and building a
Drugs
FDA has approved a Pfizer NDA for Xeljanz XR (tofacitinib citrate) extended-release 11 mg tablets for once-daily treatment of moderate to severe rheumatoid arthritis (RA) in patients who have had an inadequate response or intolerance to methotrexate. Pfizer says Xeljanz XR is the first once-daily oral RA
Drugs
The American Medical Association (AMA) has presented retired CBER director Karen Midthun with the Dr. Nathan Davis Award for Outstanding Government Service. “It is an honor to recognize Dr. Midthun’s important contribution to the development of critical vaccines for adults and children to combat major outbreaks ranging from influenza
Devices
FDA has cleared a Teleflex 510(k) to market its newly designed Arrow VPS Stylet. The new design features a single, double and triple lumen pre-loaded, pressure injectable Arrow Peripherally Inserted Central Catheter with Chlorag+ard technology for use with its current Arrow Vascular Positioning System (VPS) platform. “Together
Drugs
FDA and the Foundation for the National Institutes of Health Biomarkers Consortium are co-sponsoring a two-day workshop on “Developing an Evidentiary Standards Framework for Safety Biomarkers Qualification.” The purpose of the workshop is to discuss the evidentiary standards needed to support biomarker qualification with a particular emphasis on
FDA Policy/General
Federal Register Notice: FDA is seeking public comment on a proposed collection of information in the Outcomes Evaluation Survey for Graduates of the FDA Commissioner's Fellowship Program. Comments should be submitted by 4/25. To view this notice, click here.
Drugs
Attorney Chelsea Rutherford (McDermott Will & Emery) says that the HHS Inspector General has been issuing advisory opinions that revise its approach to patient assistance programs (PAPs) that provide financial assistance or free prescription drugs to low-income individuals. “While none of these opinions or modifications are dramatically new on
Drugs
Stakeholders responding to an FDA draft guidance on advancement of emerging technology applications to modernize the pharmaceutical manufacturing base are asking the agency for additional information and clarification. Pharmaceutical Research and Manufacturers of America (PhRMA) says FDA should clarify the scope and extent of the technologies covered, acceptance criteria for
Drugs
Helsinn Healthcare has petitioned FDA to not approve a recently submitted 505(b)(2) NDA from Exela Pharma Sciences referencing Helsinn’s Aloxi (palonosetron hydrochloride) injection, indicated for preventing chemotherapy-induced nausea and vomiting. Submitted on behalf of the company by the law firm Hogan Lovells, the petition argues that
Devices
Research conducted by University of Pennsylvania Wharton School professors on second and third generation coronary stents supports the FDA position that reductions in medical device approval standards would reduce consumer welfare. But it also supports FDA reform proposals saying that more relaxed premarket requirements and enhanced post-market surveillance would
FDA Policy/General
Federal Register Notice: FDA is requesting expressions of interest from organizations that evaluate clinical evidence used to support private payer coverage decisions for medical devices that wish to provide input to medical device developers (sponsors) on clinical trial design or other plans for gathering clinical evidence needed to support positive