Drugs
Sen. Gary Peters (D-MI) says he is investigating the rising costs of prescription drugs and the short supply of critical medications affecting hospitals and patients. According to Peters’ statement, unaffordable prescription and hospital-administered drugs and the increasing number and length of drug shortages “have become an economic, national
Devices
CDRH Office of Strategic Partnerships and Technology Innovation senior policy analyst Stacy Cho says the Accreditation Scheme for Community Assessment (ASCA) pilot program being developed by CDRH should improve efficiency of the premarket review process by building confidence in a declaration of conformity through utilization of accredited testing laboratories. She
Biologics
FDA has approved a Sanofi supplemental BLA for Fluzone High-Dose Quadrivalent (Influenza Vaccine) for use in adults 65 years of age and older. The vaccine was originally approved in 2009 as a trivalent influenza vaccine, including two influenza A strains and one influenza B strain. The high-dose vaccine
FDA Policy/General
The Alliance for a Stronger FDA is advocating for increased FDA funding in fiscal year 2020 because “growing responsibilities require a budget that grows.” That was the message during an 11/6 Webinar from Alliance deputy executive director Steven Grossman as he discussed FDA’s positioning in the current funding
Devices
FDA says a 9/10 Zimmer Biomet recall of 86 ROSA Brain 3.0 robotic surgery systems is Class 1. The units were recalled due to a software issue that could drive the system robotic arm to an incorrect position, resulting in patient risk. An FDA notice says Zimmer has
Drugs
A 9/24-9/25 tripartite meeting between FDA, the European Medicines Agency, and the Japanese Pharmaceuticals and Medical Devices Agency discussed further alignment on clinical trial designs for key indications for antibacterial drugs for which convergence has not yet been reached. A statement indicates that the agencies agreed that
Drugs
An FDA October inspection at two Aurobindo Pharmaceutical drug manufacturing facilities in Hyderabad, India, raised concerns about contamination of equipment. The News Minute, an online India news source, reports that the U.S. agency “raised concerns over the lack of hygiene and cleanliness at these facilities.” The online post says
Devices
FDA has cleared a Conformis 510(k) for its Conformis Hip System. Similar to the design process for the company’s knee system, the hip system uses proprietary advanced imaging and design software to deliver a patient-specific pre-operative surgical plan with a comprehensive set of iJig instruments and
Drugs
Unlearn.AI founder and CEO Charles Fisher, whose company uses artificial intelligence (AI) to streamline clinical trials and make them more efficient, says FDA should be moving to set standards for using AI in drug development. Writing in a Stat online post, Fisher says that AI “can improve efficiency and
Devices
FDA is currently a member of two collaborative communities that have been established and are managed and controlled by external stakeholders. Speaking at a 10/29 Webinar on collaborative communities, CDRH director of patient science and engagement Michelle Tarver identified the two groups as the Ophthalmic Imaging Collaborative Community that
Drugs
FDA has cleared a UVision360 510(k) for the 3mm Luminelle Dx 360 Rotatable Disposable Sheath, an attachment for the Luminelle DTx Hysteroscopy System. The device features high-definition optical clarity through its wide-angle lens, long depth of view and a proprietary Smart Focus Algorithm that auto-adjusts focus
Drugs
Public Citizen is petitioning FDA and the Drug Enforcement Administration to initiate proceedings to reschedule 2-[(dimethylamino)methyl]-I-(3-methoxyphenol)cyclohexanol, its salts, its optical and geometric isomers, and salts of these isomers, including Tramadol, from Schedule 4 to Schedule 2 of the Controlled Substances Act. The petition says
Drugs
CBER has issued a Standard Operating Policy and Procedure on scheduling and conducting regulatory meetings between individuals in the Center and industry representatives, including sponsors/applicants of user fee related products, and/or individual sponsor-investigators to address issues relating to product development. The document applies to meetings for INDs,
Drugs
GlaxoSmithKline is asking FDA to review four categories of information concerning the use of Zofran (ondansetron) in pregnancy and determine whether there should be any labeling changes. “GSK understands that FDA may be reviewing or will soon review, together with Zofran’s current NDA holder, Novartis, Zofran’s safety profile
Devices
FDA has cleared a Vyaire Medical 510(k) for the bellavista 1000e ventilator. The device features a touch screen that provides advanced graphics to easily visualize a patient’s pulmonary status. The company says it also simplifies the user process by offering “optimal workflows with the goal of reducing operator
Biologics
CBER has posted a document providing “Instructions for Using the Electronic Human Cell and Tissue Establishment Registration System (eHCTERS).” Establishments that manufacture such products are required to register and list their products electronically with FDA for the manufacturing steps they perform using eHCTERS (21 CFR Part 1271). Establishments that manufacture
FDA Policy/General
Federal Register notice: FDA has published a list of eight information collections that have been approved by OMB. They are: * Agreement for Shipment of Devices for Sterilization * Substances Prohibited fromUse in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed * Clinical Laboratory Improvement Amendments Waiver Applications * Registration and Product
Drugs
CDER says the phased implementation of the reorganization of the Office of New Drugs is well underway, with Phase 2 implementation having started 11/4. A notice says Phase 2 will occur over several weeks and involve selecting leadership for several new divisions, including directors for the Divisions of Pharm/
Drugs
FDA has released the FDA-483 with seven observations issued following an 8/27-9/11 inspection at Innoveix Pharmaceuticals, an Addison, TX, producer of sterile and non-sterile drug products. The inspection observations were: * unprotected product intended to be sterile was exposed to lower than ISO 5 classified aseptic
Drugs
Pfizer CEO Albert Bourta says that payers are trapped and can’t cover biosimilars because they would lose the benefit of rebates offered by the innovator companies. “Unless we resolve this big issue,” he said on a third quarter conference call, “we will never be able to see tremendous progress
Drugs
IQVIA (formerly IMS Health and Quintiles) says an FDA draft guidance on general pharmacology considerations for neonatal studies for drugs and biological products provides a helpful explanation of the agency’s current thinking on the topic. The firm’s comment letter says it strongly advocates that generation of data in
Drugs
The CDER Office of Hematology and Oncology Products (OHOP) has been reorganized as the Office of Oncologic Diseases (OOD). An agency announcement says that OHOP director Richard Pazdur has been named acting director of OOD. Pazdur also directs the FDA Oncology Center of Excellence that was established in 2017 to