Devices
FDA has approved Boston Scientific’s Watchman FLX left atrial appendage closure device, indicated to reduce the risk of stroke in patients with non-valvular atrial fibrillation who need an alternative to oral anticoagulation therapy by permanently closing off the left atrial appendage. The company says the Watchman FLX is
Biologics
FDA has issued a guidance, Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use, outlining the agency’s current thinking on the regulatory criteria for minimal manipulation and homologous use. The document supersedes one that was issued 11/2017 and corrected 12/
Devices
FDA has cleared a Paige 510(k) for the FullFocus, a digital pathology image viewer for the purpose of primary diagnosis. The clearance allows in vitro diagnostic (IVD) use of FullFocus with FDA-authorized Philips Ultra Fast Scanner and paves the way for IVD use of FullFocus with additional IVD
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Centurion Medical Products, Williamston, MI (6/11): FDA inspected the company 8/2019 and cited sterile convenience kits that have not been approved or cleared by FDA. The inspection
Drugs
FDA is extending by six months its enforcement discretion policy for certain human cell, tissue, and cellular and tissue-based products (HCT/Ps) due to the Covid-19 public health emergency. The extension will provide manufacturers and potential sponsors an additional six months to determine if they need to submit
Drugs
FDA says it is currently reviewing its internal laboratory safety program to align with ongoing, shifting, and future priorities. As part of the safety program, the agency’s Office of Laboratory Safety (OLS) has also “initiated a collaborative effort to adopt and standardize a laboratory safety audit and inspection process
Drugs
FDA has accepted for review an Acadia Pharmaceuticals supplemental NDA for Nuplazid (pimavanserin) for treating hallucinations and delusions associated with dementia-related psychosis. The agency has assigned a standard review with a user fee review action date of 4/2/2021. The sNDA is based on data from a the
Drugs
Pfizer and BioNTech have announced positive data from an ongoing German Phase 1/2 trial involving its mRNA-based BNT162 coronavirus vaccine program. The data are available on an online preprint server at medrxiv. The data demonstrated the ability of BNT162 to elicit high SARS-CoV-2 neutralizing titers, the
FDA Policy/General
FDA has reissued an emergency use authorization to Quest Diagnostics to authorize its Quest SARS-CoV-2 rRT-PCR test for pooled samples of up to four individual swab Covid-19 specimens. An FDA release says this is the first Covid-19 diagnostic test to be authorized for use with
Devices
FDA has posted a final guidance entitled “Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 Public Health Emergency.” The document is intended to help with the availability of devices for use in transporting certain clinical specimens, including transport media that can be used for certain clinical specimens
Drugs
AstraZenca is reporting positive interim data from an the ongoing Phase 1-2 COV001 trial, which showed that its AZD1222 vaccine was tolerated and generated “robust immune responses against the SARS-CoV-2 virus in all evaluated participants.” Led by Oxford University, the trial involves 1,077 healthy adult participants
FDA Policy/General
Federal Register notice: FDA has withdrawn a notice of opportunity for a hearing that proposed to withdraw the approved uses of carbadox, a carcinogenic animal drug intended for use in feeds for swine. FDA is also publishing a proposed order that, if finalized, will revoke the current approved method for
FDA Policy/General
Federal Register notice: FDA has proposed an order to revoke the approved method for detecting residues of carbadox, a carcinogenic new animal drug used in swine feed. The agency is proposing to revoke the approved method for carbadox based on its determination that it is inadequate to monitor residue of
FDA Policy/General
DEVICES FDA has approved a Bracco Diagnostics PMA for Aribar Nectar (barium sulfate) oral suspension for use in modified barium swallow (MBS) examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients with known or suspected swallowing disorders. The product is designed to provide “adequate
Devices
Verathon has recalled the GlideScope Core One TouchSmart Cable, which is part of its Video Laryngoscopy System, due to the potential for temporary or complete loss of image when used with Core 10 and Core 15 video monitors. “If there is an interruption in the video signal during use, this
FDA Policy/General
Federal Register notice: FDA has announced an 8/18-19 Science Advisory Board to the National Center for Toxicological Research (NCTR) meeting. On 8/18, the NCTR director will provide a Center-wide update on scientific initiatives and accomplishments during the past year. FDA product centers will also briefly discuss
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs.” The draft describes FDA’s current thinking on incorporating real-world data and real-world evidence (including ongoing surveillance activities, observational studies, and
FDA Policy/General
Federal Register notice: FDA has announced it is revoking approval of an Eli Lilly BLA for Lartruvo (olaratumab), indicated for combination use with doxorubicin for treating adult patients with soft tissue sarcoma with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to
Drugs
FDA has sent a Warning Letter to the operators of www.pharmaboosters.com over marketing unapproved and misbranded drugs for preventing Covid-19 and a variety of other diseases such as major depressive and anxiety disorders. For example, FDA says the Web site offers Arbidol for sale and states that
Devices
FDA has cleared an Ambu 510(k) for its Ambu aScope Duodeno, a single-use duodenoscope. The device features a reusable processor unit, Ambu aBox Duodeno. Duodenoscopes are used for visual examinations of the duodenum and for diagnosing and treating conditions like gallstones, pancreatitis, tumors or cancer in the bile
Drugs
FDA has granted Denovo Biopharma a fast track designation for DB102 (enzastaurin) and its use as a potential treatment for patients with newly-diagnosed glioblastoma. Enzastaurin is a serine/threonine kinase inhibitor of the PKC beta, PI3K, and AKT pathways that has been studied in more than 3,000 patients
Drugs
Attorney Mark Schwartz (Hyman, Phelps & McNamara) says that with the planned FDA resumption of domestic inspections, there are three likely scenarios involving the still-paused foreign inspections. Writing in his firm’s FDA Law Blog, Schwartz says that either on-site foreign inspections will resume, FDA will loosen an