August 24, 2015August 24, 2015 Drug & Device Advisory Group FDA Briefs FDA News, Week of Aug 17, 2015 CDRH participation in the International Medical Device Regulators Forum (IMDRF)’s Regulated Product Submission Table of Contents (RPS ToC) Pilot Program. Developed harmonized In-Vitro Diagnostic (IVD) and non-IVD Tables of Contents (ToCs) for premarket clearance or approval. …
March 29, 2021 Drug & Device Advisory Group FDA Briefs COVID-19 News: COVID Plus monitor, BioFire respiratory panel, Screening vs Diagnostic Testing, Cure ID App COVID PLUS Monitor Tiger Tech Solutions, Inc. INDICATION FOR USE: Non-diagnostic screening device that identifies certain biomarkers that are indicative of some types of conditions, such as hypercoagulation. ADDRESSING UNMET …
FDA BRIEF: Week of November 27, 2017 FOUNDATIONONE CDx (F1CDx), in vitro diagnostic Test Foundation Medicine INTENDED USE: Next generation sequencing (NGS)-based in vitro diagnostic (IVD) test that can detect genetic mutations in 324 genes and two genomic signatures in any solid tumor type ADDRESSING UNMET NEED: Run of one test to evaluate several appropriate …
February 17, 2018 Drug & Device Advisory Group Link and Learn CDC- Public Health Image Library 2014 image depicting CDC microbiologist Valerie Albrecht, as she was holding up for observation, two Petri dish culture plates that had been inoculated with methicillin-resistant Staphylococcus aureus (MRSA) bacteria CDC-PHIL Share this: Email Print WhatsApp Like this: Like Loading… Published …
FDA BRIEF: Week of May 23, 2016 PROBUPHINE (Buprenorphine) Implant Titan Pharmaceuticals Inc. San Francicso, CA and Braeburn Pharmaceuticals, Princeton, NJ, USA INDICATION: Maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses of a transmucosal buprenorphine-containing product UNMET NEED Opioid abuse and addiction have taken …
FDA Approvals: PROBUPHINE, AXUMIN, EPI PROCOLON – Drug and Device Digest Read More »
April 26, 2020 Drug & Device Advisory Group FDA Briefs Word of Thanks from FDA Commissioner FDA Commissioner Stephen M. Hahn, M.D.thanks our nation’s essential workforce as well as the nation’s population for their efforts to combat COVID-19 Watch Share this: Email Print WhatsApp Like this: Like Loading… Published by Drug & Device Advisory Group …
FDA Budget Matters: Advancing Innovation in Digital Health Digital health tools have vast potential to diagnose and treat disease, enhance delivery of health care for the individual modern, flexible, risk-based approaches to regulation launched our Digital Health Innovation Action Plan committed to launching the digital health software precertification pilot program Sought additional resources as part of the …
February 11, 2019 Drug & Device Advisory Group FDA Briefs News & Views: Patients First, Least Burdensome Provisions, Drug Supply Chain security, 510(K) exemptions FDA’s Patient Affairs Staff (PAS)- FDA Puts Patients First PAS works with patients, caregivers, and advocates in 2019 Understanding patient experience and incorporating patient feedback into FDA’s work PAS launched several initiatives …
Transition of FDA Leadership: Dr. Ned Sharpless as Acting Commissioner Farewell to Commissioner Gottlieb READ MEET FDA and CBP bolster collaboration to protect public health and safety FDA and CBP agreement to maximize inspection and detection capabilities Prevent illegal and harmful products entering International Mail Facilities and Ports of Entry Sharing of FDA’s advanced screening technology …
August 12, 2016 Drug & Device Advisory Group Link and Learn MedSun WHAT: Work collaboratively with a network of 250 hospitals, nursing homes and home health facilities in US WHO: CDRH WHY: To assist in detecting, understanding, and sharing information on safety of devices WHEN: Launched in 2002 HOW: Secure, on-line system for reporting problems …
