Drugs
Vermont has become the first state to approve legislation permitting a U.S. drug wholesaler to import drugs from a Canadian wholesaler. The law still has to be certified by HHS. The Trump administration has opposed such drug importation. The Hill reports that HHS secretary Alex Azar called the idea
Drugs
FDA reportedly has backed away from awarding a sole source contract to the Duke-Margolis Center for Health Policy headed by former agency commissioner Mark McClellan, for whom now commissioner Scott Gottlieb used to work. Endpoint News says an initial request for proposal said the effort was to “provide supporting
Drugs
FDA has approved an Amneal Pharmaceuticals ANDA for a generic version of Daiichi Sankyo’s Welchol (colesevelam HCI) tablets, 625 mg. The product is approved along with diet and exercise for lowering LDL or “bad” cholesterol. It can be taken alone or with other statin cholesterol-lowering drugs. Welchol had
Devices
Federal Register notice: FDA has published a final order to exempt certain surgical apparel from premarket notification requirements, subject to conditions and limitations. FDA is limiting the exemption to single-use, disposable respiratory protective devices used in a healthcare setting and worn by healthcare personnel during procedures to protect both
Drugs
Some 21 health experts are offering what they describe as a comprehensive proposal to ensure universal access to safe, innovative, and affordable medicines, according to a statement from Public Citizen. The plan, published in the British Medical Journal, identifies seven critical areas of reform, with short- and long-term solutions
Devices
FDA has cleared an Additive Orthopedics 510(k) for its Patient Specific 3D Printed Bone Segments for internal bone fixation in the ankle and foot. “Our lattice structures are proving to be the next generation design as opposed to the older, more open, types of structures that rely on biologics
Drugs
The Pennsylvania Superior Court says a Philadelphia County Common Pleas Court ruled correctly that a suit against Teva and its Cephalon unit alleging illegal off-label promotion of Actiq (fentanyl citrate) oral transmucosal lozenge is preempted under federal law and regulations. The suit claimed that a patient who was prescribed
FDA Policy/General
Federal Register notice: FDA has published a list of recent information collections that have been approved by OMB. Approved collections include: * Medical Devices; Humanitarian Use Devices * Medical Devices; Device Tracking * Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine * Certification to Accompany Drug,
Drugs
Federal Register notice: FDA is seeking public comments on an information collection extension entitled “Electronic User Fee Payment Request Forms — Form FDA 3913 and Form FDA 3914” (OMB control number 0910–0805). The request forms are designed to provide the minimum necessary information for FDA to review and process a
Drugs
FDA says there were 965 bioresearch monitoring inspections in FY 2017 — 97 performed by CBER, 581 by CDER, and 287 by CDRH. The numbers are included in a metrics report. The report says that common clinical investigator deficiencies were: * failing to follow the investigational plan/agreement or regulations or both;
Drugs
FDA has issued Evolus a complete response letter related to its BLA for DWP-450 (prabotulinumtoxinA) for treating glabellar lines, also known as frown lines, in adult patients. If approved, DWP-450 would be a competitor to Allergan’s Botox. The FDA letter reportedly cited chemistry, manufacturing, and controls-related
Drugs
FDA has accepted for review an Insmed NDA for ALIS (amikacin liposome) inhalation suspension for adult patients with nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex. The agency has granted a priority review and set a user (XXX SPELLING XXX)fee review action target of 9/28. Insmed
Drugs
The federal government has intervened in five whistleblower suits accusing Insys Therapeutics of violating the False Claims Act in connection with marketing its opioid Subsys, a sublingual spray form of fentanyl. A Justice Department news release says Subsys was approved by FDA in 2012 for treating persistent breakthrough pain in
Devices
FDA has cleared a MC10 510(k) for its BioStamp nPoint system, a wireless, biometric data collection platform intended for use by healthcare professionals and researchers for continuous collection of physiological data in the home or traditional healthcare settings. The device is designed for use in clinical trials and research
Drugs
FDA researchers say that women were well represented in trials of drugs for hypertension and atrial fibrillation, and over-represented for pulmonary arterial hypertension. However, the representation of women fell below a participation to prevalence ratio of 0.8 for trials in heart failure, coronary arterial disease, and acute coronary
Drugs
FDA has approved a U.S. WorldMeds NDA for Lucemyra (lofexidine hydrochloride) for mitigating withdrawal symptoms in adults who have abruptly discontinued opioid use. FDA says that this is the first non-opioid treatment for managing opioid withdrawal symptoms, but it may only lessen the severity and is only approved
Drugs
FDA says agency scientists have discovered an inaccuracy in some data provided to the agency by a data vendor, IQVIA National Sales Perspectives, including data on certain opioid drug products. An agency statement says FDA found a discrepancy in the IQVIA data that showed a more than 20% drop in
Drugs
FDA has updated a safety alert for all gadolinium-based contrast agents (GBCAs) for MRIs to include an agency-approved new patient Medication Guide. Late last year, FDA required a new class Warning and other safety measures for all GBCAs for MRIs. The Warning concerns retention of gadolinium in patients’
Drugs
FDA has accepted the EndoLogic cardiac safety trial for renzapride is patients with gastroparesis. The company says the study demonstrated no evidence of QTc prolongation in the EKG findings. “FDA views this study as sufficient to characterize renzapride’s QTc prolongation potential at both therapeutic (4 mg/day) and supra-
Devices
FDA has cleared a Ventripoint Diagnostics 510(k) for its VMS+ machine with a four-chamber heart analysis system, intended for use in the analysis of ejection fraction (function) and volumes in any chamber of the heart. “The VMS+ is the first simple echocardiography system to be approved by the
FDA Policy/General
Federal Register notice: FDA has announced a 7/18-19 Blood Products Advisory Committee. On the first day of the meeting, panel members will provide advice regarding bacterial risk control strategies to enhance the safety and availability of platelets for transfusion. On the second day, the panel and members from
Devices
FDA has cleared a BacterioScan 510(k) for its 216Dx Urinary Tract Infection detection system. The rapid automated diagnostic system uses an advanced laser sensor to detect infections, reducing lab turnaround time to about three hours, an improvement of up to 90% compared with traditional testing approaches, according to the