Drugs
AbbVie says it expects FDA to make a decision before summer on a new indication for its Orilissa (elagolix) to treat uterine fibroids in premenopausal women. The Philadelphia Inquirer reports the agency is considering results from two clinical trials conducted at 77 sites in the U.S. and Canada in
FDA Policy/General
ABH Nature's Products, ABH Pharma and Stocknutra.com is conducting a nationwide recall of its dietary supplement products manufactured and sold between 1/2013 to 11/2019. The products are being recalled after an FDA inspection found significant GMP violations, according to a recall notice. To date, it
Devices
FDA has cleared a Baze 510(k) for its at-home blood collection process. The testing kit is intended to assess blood nutrient status, which Baze analyzes to offer nutrition plans and supplement subscriptions curated for individual customers, the company says. It uses the company’s Nutrition Information System to
Devices
FDA has given Medtronic approval to proceed with an IDE trial (PULSED AF) to evaluate the safety and effectiveness of the PulseSelect Pulsed Field Ablation (PFA) System, a new technology that uses pulsed electric fields to treat atrial fibrillation. The company says that PFA uses pulsed electric fields to ablate
Devices
Wisconsin cardiologist Nalini Rajamannan, medical director of the Most Sacred Heart of Jesus Cardiology and Vascular Institute, has sent FDA commissioner Stephen Hahn an affidavit arising from her years of effort to get the agency to release information to 667 patients who were implanted with the Edward Lifesciences Myxo ETlogix
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Reporting Associated With Animal Drug and Animal Generic Drug User Fees” (OMB Control Numbers 0910-0540). The information is used by CVM to initiate the administrative screening of new animal drug applications and supplements. To view the
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Electronic Products — 21 CFR Parts 1000 Through 1050” (OMB Control Number 0910-0025). FDA has the authority to establish and carry out an electronic product radiation control program, including the development, issuance, and administration of performance standards
FDA Policy/General
Federal Register notice: FDA has determined that Chiesi USA’s Cardene (nicardipine hydrochloride) injection, 25 mg/10 ml, was not withdrawn from sale for safety or effectiveness reasons. The determination will allow FDA to approve ANDAs for nicardipine hydrochloride injection if all other legal and regulatory requirements are met. Cardene
Drugs
FDA has published a guidance, Assessing User Fees Under the Biosimilar User Fee Amendments of 2017, to give stakeholders information on FDA implementation of the Biosimilar User Fee Amendments of 2017 (BsUFA 2), which created changes to the user fee program. The document explains the new fee structure and the
Devices
FDA says it wants to raise awareness about cybersecurity vulnerabilities in certain GE Healthcare Clinical Information Central Stations and Telemetry Servers that may introduce risks to patients while being monitored. An agency safety communication says the devices are used mostly in healthcare facilities for displaying information such as patients’ physiologic
FDA Policy/General
Federal Register notice: FDA has classified radiological computer-aided triage and notification software into Class 2 (special controls). The classification was made based on a de novo request by Vizai for its ContaCT device. FDA has identified the product as an image processing device intended to aid in prioritization and
FDA Policy/General
Federal Register notice: FDA has classified the radiological computer-assisted diagnostic (CADx) software for lesions suspicious for cancer into Class 2 (special controls). The classification was made after Quantitative Insights submitted a de novo request for its QuantX device. FDA identified the product as an image processing device intended to
FDA Policy/General
Federal Register notice: FDA has issued an order to reclassify medical image analyzers, including CADe devices, for mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection from Class 3 to Class 2 (special controls). The order assigns such devices the generic name medical image analyzer,
Drugs
FDA says it has determined that Purell Healthcare Advanced Hand Sanitizer products marketed by Gojo Industries, Cuyahoga Falls, OH, are intended for use as consumer and healthcare antiseptics and, as formulated and labeled, are unapproved new drugs. A 1/17 Warning Letter lists some of the company claims for the
Drugs
FDA has denied an 8/29/19 Persion Pharmaceuticals petition asking that the agency take two specific actions regarding ANDAs for generic Zohydro ER (hydrocodone bitartrate) extended-release capsules. The petition asked that FDA require: * that any ANDA for generic Zohydro ER contain bioequivalence data from testing in hepatically impaired
Drugs
FDA has released a list of potential signals of serious risks/new safety information identified by the FDA Adverse Event Reporting System that occurred between 9/2019 and 12/2019. The list includes 15 potential signals for a number of different drugs and shows what the potential signal is and
Drugs
[Report by David McFarland] How is it that Sarepta is able to again win FDA approval for a Duchenne muscular dystrophy (DMD) drug despite significant resistance from agency superiors? Just-posted approval documents from last month’s green light for Sarepta’s DMD drug Vyondys 53 (golodirsen) shed some light
Drugs
The Justice Department says that Patient Services Inc. (PSI) a foundation based in Virginia, has agreed to pay $3 million to resolve allegations that it violated the False Claims Act by acting as a conduit through which some drug companies could provide kickbacks to Medicare patients taking the companies’ drugs
Devices
FDA has cleared a Teleflex 510(k) for the Wattson Temporary Pacing Guidewire, a bipolar device designed for use during transcatheter aortic valve replacement (TAVR) and balloon aortic valvuloplasty. The device includes a 0.035-inch pigtailed guidewire that supports valve delivery and allows simultaneous intraventricular bipolar pacing during procedures,
Drugs
Two former Insys executives were sentenced to more than two years in federal prison each for their roles in a bribery and kickback scheme that prosecutors said helped to fuel the opioid crisis. Former national sales director Richard Simon was sentenced to 33 months in prison and former regional sales
Devices
FDA has approved a Medtronic PMA for the Micra AV, which it describes as the world’s smallest pacemaker with atrioventricular (AV) synchrony. The device is indicated for treating patients with AV block, a condition in which the electrical signals between the chambers of the heart (the atria and the
Drugs
A 7/15-7/18/19 FDA inspection at Zhuhai Aofute Medical Technology Co., Zhuhai, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 1/9 Warning Letter says the specific violations were: * failing to have for each batch of drug product appropriate laboratory