Drugs
An FDA safety alert is warning consumers about establishments in several states that are offering young-donor plasma infusions to treat various conditions. “The conditions range from normal aging and memory loss to serious diseases like dementia, Parkinson’s disease, multiple sclerosis, Alzheimer’s disease, heart disease or post-traumatic
Biologics
FDA has approved a Novo Nordisk BLA for Esperoct (turoctocog alfa pegol) for treating adults and children with hemophilia A. The therapy is indicated for routine prophylaxis to reduce the frequency of bleeding episodes, on-demand treatment and control of bleeding episodes and perioperative management of bleeding. Approval is based
Devices
The federal government has intervened in a False Claims Act case alleging that Alere’s Arriva Medical unit submitted or caused false claims to be submitted to the Medicare program for medically unnecessary glucometers and paid kickbacks to Medicare beneficiaries in the form of free glucometers and copayment waivers. The
Drugs
FDA Oncology Center of Excellence director Richard Pazdur says although there has been recent progress in risk stratification in hormone receptor-positive breast cancer, there is a need for more sophisticated prognostic-biomarker testing to identify high-risk patients in time to intervene and improve outcomes. Writing in the New
Drugs
FDA has released the FDA-483 containing two observations from a 1/28-2/8 inspection at Lupin Limited, a Goa, India, drug product manufacturer. The observations were: * failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of
Drugs
Researchers who examined the Risk Evaluation and Mitigation Strategy (REMS) for transmucosal immediate-release fentanyl (TIRF) products and surveyed providers, pharmacists, and patients say that while there generally was adequate knowledge about using TIRFs, some survey items and claims-based analyses indicated substantial rates of inappropriate use. A Journal of
Devices
FDA has granted Medtronic a breakthrough device designation for its investigational Personalized Closed Loop (PCL) insulin pump system. The company says the PCL technology is designed to automate insulin delivery in real-time, personalized and by adapting to the user. The system is also being designed to provide insights and
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Mark Berman, Beverly Hills, CA (2/13): FDA inspected the physician’s operations 7/2018 and concluded he has been manufacturing a medical device known as the Pocket Protector,
FDA Policy/General
Comments Reopened on Real World Evidence Program Federal Register notice: FDA reopens the comment period on a 12/7/2018 notice entitled “Framework for a Real-World Evidence Program; Availability.” 02/15/2019 Panel to Discuss Breast Implant Benefit/Risk Federal Register notice: FDA announces a 3/25-26 General
FDA Policy/General
DEVICES FDA has expanded approval for an Abiomed PMA for the Impella CP heart pump and its use in high-risk percutaneous coronary interventions (PCI). In 2016, the agecny approved Impella CP for up to four days of use to treat patients suffering from cardiogenic shock. The expanded approval allows
FDA Policy/General
Federal Register notice: FDA is reopening the comment period on a 12/7/2018 notice entitled “Framework for a Real-World Evidence Program; Availability.” The agency is taking this action to allow interested people additional time to submit comments. Electronic or written comments on the document are now due by
FDA Policy/General
Federal Register notice: FDA has announced a 3/25-26 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee meeting. Panel members are scheduled to discuss benefits and risks of breast implants indicated for breast augmentation and reconstruction concerning the following topics: (1) Breast implant associated anaplastic
FDA Policy/General
Federal Register notice: CDER is providing an opportunity for a limited number of applicants to participate in an Established Conditions Pilot Program. The program aims to propose explicit established conditions (ECs) as part drug submissions. The Center is implementing the program to gain experience receiving, assessing, and engaging with applicants
Devices
FDA has issued a draft guidance on Nonbinding Feedback After Certain FDA Inspections of Device Establishments, which proposes a process where device companies can request nonbinding agency feedback on certain kinds of documented inspectional observations that are issued on a Form 483. The document outlines a standardized method for communicating
Drugs
FDA has accepted for priority review a Merck supplemental BLA for Keytruda for use in combination with Inlyta (axitinib), a tyrosine kinase inhibitor, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). The submission is based on findings from the Phase 3 KEYNOTE-426 trial, which
Devices
FDA has finalized two guidance documents on regenerative medicine therapies that were issued as drafts 11/2017 as part of the agency’s comprehensive regenerative medicine policy framework. The first guidance, Evaluation of Devices Used with Regenerative Medicine Advanced Therapies, is intended to clarify how the agency will evaluate devices
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Exports: Notification and Recordkeeping Requirements — 21 CFR 1.101” (OMB Control Number 0910-0482). To view the notice, click here.
Drugs
FDA has issued a final rule that adds six bulk drug substances to its bulk substances listing that can be used by compounders not registered as outsourcing facilities. It also identifies four bulk drug substances that are not allowed to be used. “Developing the bulks lists for these compounders and
Devices
FDA has classified as Class 1 a Medtronic recall of its Dual Chamber Implantable Pulse Generators due to the possibility of a software error that can result in a lack of pacing. The implanted cardiac pacemakers are used to provide stimulation to increase heart rate in patients with a slow
FDA Policy/General
Federal Register notice: FDA has determined that Schering-Plough Healthcare Products’ Lotrimin (clotrimazole) topical solution, 1%, was not withdrawn from sale for safety or effectiveness reasons. The determination means that FDA will not begin procedures to withdraw approval of ANDAs that refer to the product, and it will allow the
FDA Policy/General
FDA has announced the appointment of Kaveeta Vasisht as deputy director of its Office of Women’s Health. She joined the agency in 2011 as a primary clinical reviewer and rose to be CDER Division of Clinical Trial Quality deputy director. An announcement says Vasisht will lead the scientific staff,
Devices
An 8/22-9/26/18 FDA inspection at Circulatory Technology, Oyster Bay, NY, found Quality System Regulation violations in the firm’s work as a specification developer of the Better Bladder and Bigger Better Bladder medical devices. A just-released 1/28 Warning Letter says the violations were: * failing