Devices
FDA has granted Baxter International a de novo application for the Theranova dialysis membrane. The company says the device was designed to deliver expanded hemodialysis therapy, which filters a wider range of molecules from the blood than traditional hemodialysis filters, like high-flux membranes, by “targeting effective removal of conventional
Drugs
As several Covid-19 vaccines move into final safety-efficacy demonstrations, FDA commissioner Stephen Hahn says it is possible that an emergency use authorization (EUA) could be granted before Phase 3 clinical trials are completed. In an interview with the Financial Times, Hahn said such actions will be transparent, grounded
FDA Policy/General
Quidel has entered into definitive agreements to acquire for $400 million the Triage MeterPro cardiovascular and toxicology assets and the B-type Naturietic Peptide (BNP) assay business run on Beckman Coulter analyzers from Alere Inc. The products are being divested in order to obtain antitrust approvals required for Abbott’s
FDA Policy/General
Federal Register notice: FDA has announced a 10/9 joint meeting of its Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee. Panel members are scheduled to discuss the efficacy, safety, and benefit-risk profile of an Alkermes NDA for olanzapine and samidorphan oral tablets, indicated for
Devices
FDA has issued a draft guidance on Principles for Selecting, Developing, Modifying and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation. The document discusses best practices for incorporating patient-reported outcome (PRO) instruments throughout a medical device’s lifecycle. It touches on the qualities of PRO instruments
FDA Policy/General
Federal Register notice: FDA has announced a 10/22 Vaccines and Related Biological Products Advisory Committee meeting. Panel members are scheduled to discuss the development, authorization and licensure of Covid-19 vaccines. The agency says no specific application will be discussed at the meeting. To view the notice, click here.
Drugs
FDA has published new product-specific guidances (PSGs) that provide recommendations for developing generic drugs and generating data needed to support ANDA approval. The latest batch include 19 new and 17 revised PSGs. Specifically, FDA is revising the PSG on liposomal amphotericin B injection, an antifungal used to treat fungal
Drugs
FDA commissioner Stephen Hahn has removed newly appointed chief spokeswoman Emily Miller in the wake of his controversial remarks exaggerating the efficacy of convalescent plasma for Covid-19 he made at an 8/23 White House press conference. Miller was installed at FDA by the White House less than two
Devices
FDA has granted Synchron a breakthrough device designation for Stentrode, an implantable medical device that can translate brain activity or stimulate the nervous system from inside a blood vessel without the need for open brain surgery. The device is currently being evaluated for its ability to enable patients with paralysis
Devices
FDA 8/28 issued an alert to healthcare facilities to stop using medical gowns, including surgical gowns, manufactured or sold by New York City-based Laws of Motion PPE.com until further notice because they may not provide their labeled level of protection, including fluid barrier protection. The agency’s
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Evaluating Cancer Drugs in Patients with Central Nervous System Metastases. The document provides recommendations on clinical trial designs for drugs and biological products that are intended to support product labeling describing the antitumor activity in patients with central nervous
Drugs
FDA has approved a Cassiopea NDA for Winlevi (clascoterone cream 1%) for treating acne in patients 12 years and older. The approval represents the first new mechanism of action for an acne drug in almost 40 years, the company says. The drug targets the androgen receptors directly in the skin
Drugs
The Justice Department says Teva is the seventh generic drug manufacturer to be charged with conspiring to fix prices, rig bids, and allocate customers for generic drugs. A department statement says a superseding indictment filed 8/25 in a Pennsylvania federal court alleges that the company participated in three conspiracies
Devices
FDA has cleared a B. Braun Medical 510(k) for the SpaceStation MRI to allow Space infusion pumps to continuously deliver medications to patients within magnetic resonance imaging (MRI) suites. The device is designed to shield Space infusion pumps against 1.5-T and 3.0-T magnetic fields to
Devices
FDA has granted an emergency use authorization (EUA) for the Abbott BinaxNOW Covid-19 Ag Card, described as a fast, $5, 15-minute, easy-to-use Covid-19 antigen test. The company says it is offering a no-charge complementary phone app that allows people to display their BinaxNOW test
Devices
FDA has approved Foundation Medicine’s FoundationOne Liquid CDx, a comprehensive pan-tumor liquid biopsy test. The company says the approval includes companion diagnostic claims for Rubraca (rucaparib), the first PARP (poly ADP ribose polymerase) inhibitor approved in a prostate cancer setting, and three tyrosine kinase inhibitors for non-small
Devices
Public Citizen is suing FDA to compel the agency to respond to the advocacy group’s 2015 petition asking that Baxter’s Seprafilm Bioresorbable Membrane be banned. Seprafilm is a material used by surgeons during abdominal and pelvic surgery to prevent internal organs from forming fibrous bands of tissue that
Devices
A new Internet of Things (IoT) vulnerability discovered by IBM’s X-Force Red hacker team could affect many Internet-connected devices, including medical devices, according to a Security Intelligence post. The hacker team reportedly found a vulnerability in a module used in many devices. The affected Thales modules are
Drugs
The FDA Oncology Center of Excellence and the LUNGevity Foundation have launched a multi-year longitudinal study to understand the lung cancer patient experience, irrespective of diagnosis (stage/histology), outside of the clinical setting. Project PEER (Understanding the Lung Cancer Patient Experience in the Real-World Setting) seeks to systematically
Biologics
Three law professors from different U.S. universities are joining the chorus of those expressing concern that FDA is under too much political pressure to make positive decisions on products to help resolve the Covid-19 pandemic. In a piece distributed online to be used as an op-ed, the
Drugs
Although Stericycle predicted a drop in product recalls during the Covid-19 shutdown of the U.S. economy that started at the end of the first quarter, recalls continued at their typical level, according to the company’s second-quarter report. The report section on medical devices says those companies
Devices
FDA has approved a Med-EL USA PMA supplement for the Rondo 3 Audio Processor for use with its Synchrony Cochlear Implant System. The company says the Rondo 3 offers wireless streaming, wireless charging with a rechargeable battery that lasts up to 24 hours, and compatibility with all hearing aids