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
Drugs
FDA says it is launching the Drug Risk Management Board, a “unified Center-level body that will ensure seamless alignment for marketed product safety activities among offices and will facilitate rapid analysis and resolution of drug safety issues.” An internal memo from CDER director Janet Woodcock says the board will
Devices
FDA has published a guidance, Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions, with recommendations for industry, systems and service providers, consultants, agency staff, and others on clinical performance assessment of computer-assisted detection (CADe)
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. CGA Limited Laventille, Trinidad & Tobago (12/19): FDA inspected the company in May and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to test
Biologics
FDA has approved a Horizon Therapeutics BLA for Tepezza (teprotumumab-trbw) for treating adults with thyroid eye disease, a rare condition where the muscles and fatty tissues behind the eye become inflamed, causing the eyes to be pushed forward and bulge outwards (proptosis). Approval was based on data from two
Drugs
The Government Accountability Office (GAO) has laid out six policy options in response to challenges it says hinder the adoption and impact of machine learning in drug development. The options are in a GAO report on artificial intelligence in health care undertaken in response to a congressional request. The report
Drugs
CDER says that the approved restructuring of the Office of New Drugs (OND) created offices that align interrelated disease areas and divisions with clearer and more focused areas of expertise. As a result, an online notice says, the names of the OND offices and divisions have changed. CDER says sponsors
Drugs
A 5/20-5/24/19 FDA inspection at Tismor Health and Wellness, Kingsgrove, Australia, found significant violations of current good manufacturing practice (CGMP) regulations in the firm’s work as a contractor producing finished drugs. A just-released 12/5/19 Warning Letter says specific violations were: * failing to
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Radioactive Drug Research Committees—21 CFR 361.1” (OMB Control Number 0910-0053). FDA has authority to establish radioactive drug research committees to approve and monitor basic research studies using radiopharmaceuticals. To view the notice, click here.