Drugs
A Public Citizen petition calls on FDA to disqualify two researchers at Hennepin County Medical Center, Minneapolis, MN, who “repeatedly and deliberately violated agency regulations intended to protect human subjects.” The advocacy group says the doctors conducted a series of clinical trials that tested the general anesthetic ketamine and powerful
FDA Policy/General
FDA has granted fast track designation to AstraZeneca’s Lokelma (sodium zirconium cyclosilicate) for a new indication to reduce arrhythmia-related cardiovascular outcomes in patients on chronic hemodialysis with recurrent hyperkalemia. The company says the designation is based on Lokelma’s potential to reduce serious adverse cardiovascular outcomes in that
Drugs
FDA has granted fast track designation for Zentalis Pharmaceuticals’ ZN-c3, an oral WEE1 inhibitor product candidate for the treatment of recurrent or persistent uterine serous carcinoma in adult women. The company says ZN-c3 is a potentially first-in-class and best-in-class oral inhibitor of WEE1 in
Drugs
The Alzheimer’s Association is providing seed money to launch a new National Treatment and Diagnostic Alzheimer’s Registry. The advocacy organization says the registry will be an “FDA-approved agent agnostic approach to gathering routine clinical practice data and outcomes for sharing quickly and transparently with all stakeholders.” The
Drugs
Two Wiley Rein attorneys say a proposed FDA requirement to report the amount of listed drugs and biological products under section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act represents a big change for many companies that have not had to report distribution data to the agency.
Drugs
SterRx has recalled 240 lots of various drug products within their expiry period due to equipment and process issues that could lead to a lack of sterility assurance. To date, SterRx has not received reports of any product complaints or adverse events associated with the issue. Affected products are: * lmg/
Devices
FDA has cleared an Avinger 510(k) for a new clinical indication for the Pantheris image-guided atherectomy system — treating in-stent restenosis in the lower extremity arteries. Clearance was based on data generated from the INSIGHT trial, a prospective, global, single arm, multi-center study, according to the company.
Devices
Cook Group says the FDA non-in vitro diagnostic electronic submission template and resource (eSTAR) is easy to use and intuitive, while also driving standardization. In an 11/12 comment letter on an agency draft guidance on the electronic submission template for medical device 510(k) submissions, Cook says additional
Devices
FDA has granted Blackrock Neurotech a breakthrough device designation for its MoveAgain Brain Computer Interface System. The device is intended to provide immobile patients the ability to control a mouse cursor, keyboard, mobile device/tablet, wheelchair or prosthetic device by thinking. It comprises an array implanted in the brain, which
Drugs
CytoDyn has begun resubmitting a rolling BLA for leronlimab, a CCR5 antagonist used in combination therapy with highly active antiretroviral therapy for highly treatment-experienced HIV patients. Last year, FDA issued CytoDyn a refusal to file letter on its BLA because the submission did not contain certain information needed to
Drugs
FDA says that under the Model-Informed Drug Development (MIDD) pilot program, it is asking the MIDD meeting requests and meeting packages to include elements of a credibility framework to facilitate alignment and streamline review. The MIDD pilot is being conducted to facilitate the development and application of exposure-based,
Drugs
With at least two additional ameloyd-β Alzheimer’s drugs in the pipeline, scientists interviewed for a Nature explainer are wondering how FDA will review and decide on the drugs’ fate given the furor over its accelerated approval of Biogen’s Aduhelm (aducanumab). “Some researchers think that the [Aduhelm] approval
Drugs
Researchers from Yale and Columbia universities say FDA “can and should harness its enforcement tools to ensure timely submission of trial results information to ClinicalTrials.gov. By doing so, FDA could bring important missing results to light and demonstrate its commitment to protecting patients through clinical trial transparency.” Writing in
Devices
FDA has authorized the de novo marketing of AppliedVR’s EaseVRx, a prescription-use immersive virtual reality (VR) system that uses cognitive behavioral therapy and other behavioral methods to help with pain reduction in patients 18 years of age and older with diagnosed chronic lower back pain. EaseVRx uses cognitive
Devices
FDA has granted Medtronic 510(k) clearance for its PillCam Small Bowel 3 system for remote endoscopy procedures. The device provides a telehealth option for direct visualization and monitoring of the small bowel to help detect lesions not detected by upper and lower endoscopy that may signal Crohn’s disease,
Drugs
A 10/13-10/29/20 FDA inspection at Advanced Neutriceuticals, doing business as Guyer Institute of Molecular Medicine, Indianapolis, IN, found multiple violations of laws and regulations. An 11/10 Warning Letter says the firm failed to meet conditions for exemption from certain provisions of the Federal Food, Drug,
Drugs
Pfizer says it will submit new data as part of its rolling Emergency Use Authorization request for its Covid-19 oral antiviral Paxlovid (ritonavir) that showed the drug significantly reduced hospitalization and death. The data come from an interim analysis of the Phase 2/3 EPIC-HR (Evaluation of Protease
Drugs
Reps. Fred Upton (R-MI) and Donna DeGette (D-CO) have introduced the 173-page bipartisan Cures 2.0 legislation to change how the U.S. provides care to patients and to speed the delivery of groundbreaking cures, treatments, and innovations. One of the bill’s key provisions is the
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) and the Deloitte Center for Health Solutions have issued a report with five strategies for enhancing diversity in clinical trials during the research and development of new medicines. The report, “Enhancing Clinical Trial Diversity: Stakeholder Perspectives on Advancing Research Through Representative Clinical Trials,
Biologics
CBER has issued NYC Regenerative Medicine an untitled letter over its Web site and Facebook page that markets its cellular product derived from human umbilical cord for treating kidney disease and other conditions. The agency says such products are considered biologics and require an approved BLA to be marketed in
Devices
FDA has published a revised guidance entitled Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 Public Health Emergency. The agency says that policy set forth in this guidance will help address public health concerns regarding the availability of such transport media devices and therefore help expand the
FDA Policy/General
Federal Register notice: FDA has issued an order granting special termination of the debarment involving Sanyasi Raju Kalidindi. FDA based the order on a finding that Kalidindi provided substantial assistance in the investigations relating to a matter under the agency’s jurisdiction. To view the notice, click here.