FDA Policy/General
A floor vote on FDA’s fiscal year 2024 budget bill was passed over 7/27 by House Republican leadership eager to begin the chamber’s August recess early, shelving the legislation until September when Congress returns. The measure was put on hold “amid internal discord about funding levels and
Devices
FDA has cleared an UltraSight 510(k) for its artificial intelligence-powered ultrasound guidance technology. The software is intended to assist medical professionals without sonography experience in obtaining cardiac ultrasound images at the point of care in multiple settings. UltraSight says its software will “enable hospital staff to advance patient
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations — Premarket Notification (510(k)) Submissions.” The document’s recommendations are intended to promote the safe and effective use of such products. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality.” The document is intended to facilitate submissions by external stakeholders and FDA staff proposing voluntary consensus standards related to pharmaceutical quality. The Center says the
Devices
An FDA update for healthcare providers has been issued to clarify that the intended use of radiological computer-aided triage and notification (CADt) devices for intracranial large vessel occlusion (LVO) is to triage suspected findings of LVO based on the analysis of brain radiological exams. CDRH says it is working
Devices
FDA has cleared a Shenzhen Superbio 510(k) for a point-of-care instrument intended for the qualitative detection of fentanyl in human urine. The Fentanyl Urine Detection Kit is a fluorescence immunoassay intended for use with Carolina Liquid Chemistries Corp. immunofluorescence analyzer RYAN. It provides a preliminary test result,
FDA Policy/General
Federal Register notice: FDA is announcing a 9/27 Cellular, Tissue, and Gene Therapies Advisory Committee meeting. Panel members are scheduled to discuss and make recommendations on a BrainStorm Therapeutics supplemental BLA for debamestrocel (autologous bone marrow-derived mesenchymal stromal cells induced to secrete neurotrophic factors). The company’s submission
FDA Policy/General
Federal Register notice: FDA is permanently debarring Diana Daffin from providing services in any capacity to a person that has an approved or pending drug product application. The action is based on her 2022 conviction related to her Internet marketing of unapproved drugs for treating Covid-19 infections. To view
FDA Policy/General
Attorney Tim Philips (Gardner Law) says both industry and consumers should be concerned about the proposed FDA reorganization of the Office of Regulatory Affairs (ORA). In a detailed online analysis of the proposal, Philips says that over the years many regulated companies have developed good relationships with their FDA district
Drugs
Sun Pharma is asking FDA to ask the manufacturers of unapproved phenobarbitol products to recall drugs that contain excipients that are known to be harmful to neonates. It also is asking the agency to inform the public and healthcare providers about the “serious risks associated with the use of unapproved
Drugs
FDA has released the form FDA-483 issued following a 2/27-3/30 inspection at Central Admixture Pharmacy Services, an Allentown, PA, outsourcing facility. The six inspection observations were: * failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet
Devices
Three SheppardMullin attorneys say FDA appears to be focusing enforcement on “intended use creep” that occurs when companies promote the capabilities of medical device software outside the scope of the intended use that was stated when the device was cleared. The attorneys’ online post discusses in detail a 6/21
Drugs
FDA has published a guidance, CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality, to describe the agency’s participation in the development and use of technical voluntary consensus standards that are integral to its mission. The document says FDA has used such standards to
Drugs
FDA has approved an Octapharma NDA for Balfaxar (prothrombin complex concentrate) for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (e.g., warfarin) therapy in adult patients needing urgent surgery or invasive procedures. Balfaxar is a non-activated four-factor prothrombin complex concentrate (4F-PCC)
Devices
Abbott is recalling its Amplatzer Steerable Delivery Sheath due to an increased risk for air bubbles (air emboli) to be introduced into patients undergoing procedures. “Air embolism can lead to injuries such as sudden (acute) reduction in blood flow to the heart (indicated by ST elevation), fast or slow heartbeat
Drugs
Defender Pharmaceuticals has submitted an NDA for its intranasally administered scopolamine gel (DPI-386 Nasal Gel) for preventing motion-caused nausea and vomiting in adults. Scopolamine has been marketed for decades in a transdermal patch formulation and Defender believes its unique intranasal gel formulation offers the ability to bring faster
Drugs
FDA has cleared a Beckman Coulter 510(k) for its DxC 500 AU Chemistry Analyzer, an automated analyzer intended for use by small-to-medium-sized laboratories. The device uses standardized assays and reagents, the company says, adding that it offers a “broad menu of 120-plus assays. The analyzer
Drugs
FDA says that a “reverse-FOIA [Freedom of Information Act]” lawsuit seeking to keep an unnamed company attorney’s identity secret (see earlier story) in connection with a form FDA-483 should be dismissed because the suit failed to state a claim for which relief can be granted. The suit,
Drugs
The 3rd Circuit Court of Appeals says a Pennsylvania federal court correctly rejected a Department of Justice request for a conspiracy charge against KVK-Tech, a Newtown, PA, generic drug manufacturer. The lower court had said the government’s indictment failed to state the offense and the government had appealed
Biologics
A 10/2/21-11/10/21 inspection at Stratus Biosystems, doing business as CellGenuity Regenerative Science in Grapevine, TX, documented that the firm manufactures products for allogeneic use, including an umbilical cord and amniotic membrane-derived product and an amniotic fluid-derived product. A 6/5 Warning Letter says
Drugs
FDA has denied petitions submitted by Vanda Pharmaceuticals on 1/25 and 1/27 asking that the agency revoke approval of ANDAs held by Teva and Apotex for generic forms of Hetlioz (tasimelteon) 20 mg capsules. The petitions claimed the ANDAs do not have the same labeling as the reference-
Drugs
FDA has approved a Tarsus Pharmaceuticals NDA for Xdemvy (lotilaner ophthalmic solution) 0.25% for treating Demodex blepharitis, an eyelid disease caused by Demodex mite infestation. It is characterized by redness, inflammation, missing or misdirected eyelashes, horizontal itching along the eyelid base and the presence of collarettes (waste products and