Devices
FDA has cleared a Sony Electronics 510(k) for its Nucleus Operating Room Imaging Management and Collaboration Control platform. The device supports 4K resolution using existing network infrastructures, and it provides operating rooms and clinical spaces with direct access to imaging data from a central dashboard, the company says. It
Biologics
A California federal judge has denied an FDA request for summary judgment in its case against a network of clinics that the government says is offering customers unauthorized stem cell treatments. FDA had wanted to shut down activities at the California Stem Cell Treatment Center and the Cell Surgical Network,
Drugs
A study from Florida Atlantic University’s Schmidt College of Medicine finds that granulocyte colony-stimulating factor (GCSF) or Amgen’s Neupogen, which was approved in 1991 for treating neutropenia (low white blood cells) caused by chemotherapy, may offer a new way to treat strokes. Published in the Journal of
FDA Policy/General
Federal Register notice: FDA is seeking comments on a proposed study entitled “Endorser Status and Explicitness of Payment in Direct-to-Consumer Promotion.” The study intends to examine four types of endorsers (celebrity, physician, patient, social media influencer) and whether the presence of a disclosure of their payment status influences
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use — Premarket Notification (510(k)) Submissions.” The document outlines device design considerations, risk mitigation strategies, and testing recommendations for such devices. To view the notice, click here.
Drugs
FDA has issued six final guidances on gene therapy manufacturing and clinical development of products plus a draft guidance on interpreting the sameness of gene therapy products under the orphan drug regulations. In an agency statement (contains links to the guidances), CBER director Peter Marks says “as regulators of these
Drugs
FDA has just released the FDA-483 issued following a 12/5-12/13/17 inspection at Athenex Pharma Solutions, a Clarence, NY, outsourcing facility. Inspection observations were: * aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions; * aseptic processing areas are
Devices
FDA says it is aware that the Medline Industries medical device ethylene oxide sterilization facility, in Waukegan, IL, has been closed since 12/13/19. An update to the agency’s ethylene oxide sterilization Web page says FDA “understands this was a voluntary stop in operations to finish construction on
Drugs
FDA says it is requiring a new warning and updates on clozapine products and related constipation risks, which can progress to serious bowel complications, hospitalization or death. An updated safety alert says the risk is further increased at higher clozapine doses and when it is co-prescribed with anticholinergics, which
FDA Policy/General
Federal Register notice: FDA has submitted to OMB a proposed “Study of Oncology Indications in Direct-to-Consumer Television Advertising.” The study objective is to determine whether disclosing information about the nature of endpoints that support the indications for oncology products helps consumers understand a drug's efficacy. To
Drugs
A 6/24-6/28/19 FDA inspection at Sunstar Guangzhou, Guangdong, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 1/22 Warning Letter says specific violations were: * failing to perform, for each batch of drug product, appropriate laboratory determination of satisfactory conformance
Drugs
Discussions from a 10/2018 joint good clinical practice workshop held by FDA and the UK Medicines and Healthcare Products Regulatory Agency have been published in the journal of the American Society for Clinical Pharmacology and Therapeutics. The article says the workshop “provided the agencies’ perspectives on the importance of
Devices
FDA says an 8/20-9/20/19 inspection at the Draegar Medical Systems operation in Andover, MA, determined that the firm manufactures multi-parameter patient monitoring systems that are adulterated because Draegar does not have an approved PMA or IDE in place and are misbranded because the company did
Devices
FDA says the 6/14/19 Teleflex recall of 14,964 units of the Galemed Babi.Plus 12.5 cm H2O pressure relief manifold is Class 1. An agency notice says the affected units were distributed between 10/2018 and 5/2019. The device is used as part of a
Drugs
FDA has approved Boehringer Ingelheim Pharmaceuticals and Eli Lilly’s Trijardy XR (empagliflozin/linagliptin/metformin HCl) to lower blood sugar in adults with Type 2 diabetes, along with diet and exercise. Trijardy XR comprises three Type 2 diabetes medicines in one pill, including Jardiance, Tradjenta and metformin extended release. Approval
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Baja Fur City of Industry, CA (12/13): FDA inspected the firm in July and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to thoroughly
FDA Policy/General
Federal Register notice: FDA has withdrawn approval of a new animal drug application and two abbreviated new animal drug applications at the sponsors’ request because they are no longer manufactured or marketed. The products are Fleming Laboratories’ NADA for Wazine (dipiperazine sulfate and piperazine HCl); Halocarbon Products ANADA for halothane;
FDA Policy/General
Federal Register notice: FDA has extended until 3/19 the comment period for its draft guidance on “Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products; Draft Guidance for Industry; Availability.” To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment.” The document is intended to help sponsors planning to use minimal residual disease (MRD) as a biomarker in clinical trials.
Drugs
FDA is seeking comments on two proposed studies entitled “Endorser Status and Explicitness of Payment in Direct-to-Consumer Promotion.” The agency intends to examine four types of endorsers in the studies (celebrity, physician, patient, and social media influencer) and it will examine whether the presence of a disclosure of
Drugs
FDA has accepted for review a Corium 505(b)(2) NDA for Adlarity (donepezil transdermal system), for treating Alzheimer’s-type dementia. The agency has set a 7/30 user fee review target action date. The company describes Adlarity as a once-weekly transdermal formulation of Pfizer’s Aricept that
Devices
FDA has cleared a GT Medical Technologies 510(k) for an expanded indication for GammaTile Therapy — surgically targeted radiation therapy in patients with newly diagnosed malignant brain tumors. GammaTile features a bioresorbable, conformable, 3D-collagen tile and uniform radiation source, Cesium-131, GT Medical says. It is placed at the