Patient Safety and Food and Drug Administration

Selected news for the healthcare topic - Patient Safety, and the healthcare topic - Food and Drug Administration We have 233 shared news items for this connection to-date.

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Date Headline (link) Source Relevant Snippet
4/8/2021 Colorado investigating COVID-19 vaccines that were in use when Adams County site shut down Wednesday ... patient safety with the utmost seriousness, just as they did at yesterday‚Aos clinic.‚AuThe Food and Drug Administration checked with other locations that used vaccines from the same Johnson & Johnson lot, and didn‚Aot find any unusual reactions, according to the state health department. The agency determined the site followed protocols, but will also do an ‚Auafter-action‚Au analysis to learn anything that might help with similar ...
3/31/2021 AHA, ASHP seek meeting with FDA to address insurer 'white bagging' policies | FierceHealthcare FierceHealthcare ... Food and Drug Administration (FDA) Wednesday requesting an opportunity to meet with FDA officials to discuss the practice.Payers use white bagging to dispense drugs to hospitals, requiring these medications come from select network specialty pharmacies. AHA and ASHP said in the letter that doing so circumvents hospital supply chain protocols aimed at patient safety.The practice also "challenges" the supply chain security issues that are addressed in the 2013 ...
3/24/2021 German firm plea, $50M payment settles US drug purity probe ... as planned Tuesday in a U.S. court after agreeing to pay $50 million for destroying manufacturing records during a federal Food and Drug Administration inspection in India.Fresenius Kabi Oncology Ltd. said in a statement ... makes cancer drugs distributed in the U.S. The company said patient safety was safeguarded.The criminal case in Nevada came to light six weeks ago, when the agreement was unsealed in U.S. District Court in ...
3/24/2021 German firm plea, $50M payment settles US drug purity probe Star Tribune ... as planned Tuesday in a U.S. court after agreeing to pay $50 million for destroying manufacturing records during a federal Food and Drug Administration inspection in India. Fresenius Kabi Oncology Ltd. said in a statement ... makes cancer drugs distributed in the U.S. The company said patient safety was safeguarded. The criminal case in Nevada came to light six weeks ago, when the agreement was unsealed in U.S. District Court in ...
3/16/2021 The Ridgway Record RALEIGH, N.C. UVision360, Inc., an innovative FemTech company, announces today that the U.S. Food and Drug Administration (FDA) has accepted the Company's submission for expanded reprocessing procedures for use with the LUMINELLE DTx Hysteroscopy System ... be poised to support them with new reprocessing options. With patient safety top of mind and given the flexibility of our LUMINELLE DTx System to be deployed in both an operating room and a doctor's ...
10/23/2020 Role Development in Professional Nursing Practice, Fifth Edition drives comprehension through various strategies that meet the learning needs of students while also generating enthusiasm about the topic. ... effect that is not described herein. Drugs and medical devices are discussed that may have limited availability controlled by the Food and Drug Administration (FDA) for use only in a research study or clinical trial ... Quality Improvement in Professional Nursing Practice Kathleen Masters911Patient Safety Quality Improvement in Health Care Quality Improvement Measurement and Process The Role of the Nurse in Quality Improvement Conclusion ReferencesEvidence-Based Professional ...
10/1/2020 Vascular surgeons encouraged to consult talking points document on paclitaxel devices ... Patient Safety With Paclitaxel Technologies, which includes three leading vascular surgical membership bodies: the Society for Vascular Surgery (SVS), the Vascular and Endovascular Surgery Society (VESS), and the Society for Clinical Vascular Surgery (SCVS).The US Food and Drug Administration (FDA) tasked the coalition with putting together bullet points that reflect the current evidence around the hot topic of paclitaxel devices.The American College of Cardiology, American College of Radiology ...
9/30/2020 Will there be a coronavirus vaccine this year? What you need to know - CNET Experts say the race to develop an effective vaccine may be jeopardizing patient safety, especially in China, where unproven vaccines are being widely dispensed. Sept. 29, 2020 4:12 p.m. PT Listen - 07:04Experts are hopeful ... three of which are nearing the final stages needed for Food and Drug Administration approval. Considering SARS-CoV-2 -- the virus that causes COVID-19 -- was only discovered less than a year ago, the progress ...
9/16/2020 Gauss and Cellex partner on first at-home COVID-19 rapid antigen test and computer vision mobile app PRWeb ... to launch the first-ever rapid, at-home and point-of-care COVID-19 antigen test. If authorized by the Food and Drug Administration (FDA) under Emergency Use Authorization (EUA) this fall, the test would ... software that radically improves diagnostic accuracy and leads to improved patient safety and clinical outcomes. Gauss’s flagship product, Triton, leverages computer vision to detect surgical and obstetric hemorrhage in real time and notifies clinicians who ...
9/15/2020 Impact of SARS-CoV-2 & COVID-19 on Volunteer Interest in Clinical Trial Participation, Upcoming Webinar Hosted by Xtalks PRWeb ... Food and Drug Administration (FDA) acted swiftly with the publication of new guidelines and strategies on how sponsors and investigative sites could adapt to the pandemic while also emphasizing patient safety and trial integrity. While a wealth of information exists on adapting these guidelines into practice, one critical element to the maintenance of clinical trials during the COVID-19 pandemic that has not been adequately addressed is the impact on ...
9/15/2020 Joint Reconstruction Devices And Equipment Global Market Report 2020-30: Covid 19 Impact and Recovery PR Newswire ... which comes under the orthopedic devices market and orthopedic devices manufacturing is monitored by regulatory bodies such as the US Food and Drug Administration (FDA). For instance, under the Federal Food, Drug, and Cosmetic Act ... product recalls during recent years, due to defects, concerns regarding patient safety, software issue, mislabeling issue, quality issue and others, thereby affecting the growth of the market. For example, in 2018, DePuy had to recall ...
9/14/2020 Mallinckrodt Receives a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for Terlipressin for the Treatment of Hepatorenal Syndrome Type 1 (HRS-1) PR Newswire DUBLIN , Sept. 14, Mallinckrodt plc (NYSE: MNK ), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the company's New Drug Application (NDA ... and regulations; issues with product quality, manufacturing or supply, or patient safety issues; and other risks identified and described in more detail in the "Risk Factors" section of Mallinckrodt's most recent Annual Report on Form ...
9/10/2020 The Compounding Quality Coalition Commends the FDA for its Continued Commitment of Protecting Public Health PR Newswire ... multi-sector group of stakeholders from public health, manufacturing, outsourcing facilities, and the pharmacy community, issued a public comment to Food and Drug Administration (FDA) notice entitled "Agency Information Collection Activities; Proposed Collection; Comment Request ... are an essential component of their supply chain, to supporting patient safety and quality initiatives, and a key function in the operation of their pharmacies. Hospitals turn to outsourcing compounding facilities for different circumstances including ...
9/9/2020 FDA Advisory Panel Recommends Pre-Market Clinical Evidence Requirement in Proposed Reclassification of Bone Growth Stimulators Business Wire LEWISVILLE, Texas--(BUSINESS WIRE)--Sep 9, 2020-- Orthofix Medical Inc . (NASDAQ:OFIX), a global medical device company focused on musculoskeletal healing products, today announced support for the U.S. Food and Drug Administration (FDA) Medical Devices Advisory Committee, Orthopaedic and Rehabilitative Devices Panel recommendation to require robust and complete clinical data for the proposed reclassification of bone growth stimulators from Class III to Class II with “special controls” to ensure patient ...
9/8/2020 Biopharma Leaders Unite to Stand with Science | Business Wire Business Wire ... vaccine for COVID-19, is reviewed and determined by expert regulatory agencies around the world, such as the United States Food and Drug Administration (FDA). FDA has established clear guidance for the development of COVID ... and regulatory rigor, as well as their longstanding commitments to patient safety and public health. About AstraZeneca AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development ...
9/8/2020 Biopharma Leaders Unite to Stand with Science Business Wire ... vaccine for COVID-19, is reviewed and determined by expert regulatory agencies around the world, such as the United States Food and Drug Administration (FDA). FDA has established clear guidance for the development of COVID ... and regulatory rigor, as well as their longstanding commitments to patient safety and public health. About AstraZeneca AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development ...
8/31/2020 Baxter Announces U.S. FDA De Novo Authorization for Theranova Dialyzers Enabling HDx Therapy | Business Wire Business Wire DEERFIELD, Ill.- Baxter International Inc. (NYSE:BAX), a global innovator in renal care, today announced the U.S. Food and Drug Administration (FDA) has granted the De Novo application for Theranova , the company’s novel dialysis membrane ... and other governmental authorities; product quality, manufacturing or supply, or patient safety issues; changes in law and regulations; and other risks identified in Baxter's most recent filing on Form 10-K and other SEC filings ...
8/15/2020 Baxter Obtains U.S. FDA Emergency Use Authorization for Regiocit Replacement Solution Used in CRRT | Business Wire Business Wire ... Inc. (NYSE:BAX), a global leader in acute care, announced it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for Regiocit , the company’s replacement solution that contains citrate for ... by FDA); contractual requirements, product quality, manufacturing or supply, or patient safety issues; changes in law and regulations; and other risks identified in Baxter's most recent filing on Form 10-K and other SEC filings ...
8/15/2020 Baxter Obtains U.S. FDA Emergency Use Authorization for Regiocit Replacement Solution Used in CRRT Business Wire ... Inc. (NYSE:BAX), a global leader in acute care, announced it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for Regiocit , the company’s replacement solution that contains citrate for ... by FDA); contractual requirements, product quality, manufacturing or supply, or patient safety issues; changes in law and regulations; and other risks identified in Baxter's most recent filing on Form 10-K and other SEC filings ...
8/12/2020 Baxter Obtains U.S. FDA Emergency Use Authorizations for HF20 Set and ST Set Used in CRRT During Covid-19 Pandemic Business Wire ... Inc. (NYSE:BAX), a global leader in acute care, announced it has received Emergency Use Authorizations (EUAs) from the U.S. Food and Drug Administration (FDA) for the company’s HF20 Set and ST Set used in ... by FDA); contractual requirements, product quality, manufacturing or supply, or patient safety issues; changes in law and regulations; and other risks identified in Baxter's most recent filing on Form 10-K and other SEC filings ...
8/12/2020 Lantheus Holdings, Inc. Announces FDA Approval of VIALMIX® RFID Device for DEFINITY® | Business & Finance | heraldchronicle.com Business Wire ... global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, today announced the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for VIALMIX ... reduces risks related to operator or medication errors, potentially increasing patient safety. Importantly, VIALMIX RFID has been designed to work with our currently approved DEFINITY vial and our DEFINITY modified formulation product candidate. I am ...
8/12/2020 Baxter Obtains U.S. FDA Emergency Use Authorizations for HF20 Set and ST Set Used in CRRT During Covid-19 Pandemic | Business Wire Business Wire ... Inc. (NYSE:BAX), a global leader in acute care, announced it has received Emergency Use Authorizations (EUAs) from the U.S. Food and Drug Administration (FDA) for the company’s HF20 Set and ST Set used in ... by FDA); contractual requirements, product quality, manufacturing or supply, or patient safety issues; changes in law and regulations; and other risks identified in Baxter's most recent filing on Form 10-K and other SEC filings ...
8/10/2020 Mallinckrodt Announces U.S. FDA Filing Acceptance of Biologics License Application for StrataGraft® Regenerative Skin Tissue for Treatment of Adults with Deep Partial-thickness Thermal Burns PR Newswire ... STAINES-UPON-THAMES, United Kingdom , Aug. 10, Mallinckrodt plc (NYSE: MNK ), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Stratatech Biologics License Application (BLA ... and regulations; issues with product quality, manufacturing or supply, or patient safety issues; and other risks identified and described in more detail in the "Risk Factors" section of Mallinckrodt's most recent Annual Report on Form ...
7/29/2020 Ohio pharmacy board bans hydroxychloroquine as coronavirus treatment - News - The Columbus Dispatch - Columbus, OH BMJ ... Food and Drug Administration. "Basically, it’s a patient safety issue," McNamee said. "We’re looking at the best science to determine what’s best for the patients of Ohio." Read More: Ohio bought millions of hydroxychloroquine pills to combat coronavirus. Now the FDA says it shouldn’t be used to treat COVID-19 The U.S. Food and Drug Administration in mid-June revoked an emergency authorization for hydroxychloroquine which had allowed it to ...
7/27/2020 Wearable Diagnostic Devices Help Ease Pressure on Healthcare Systems PR Newswire ... overall infrastructure. For example, a report by WIRED indicates that a wearable device, which had been approved by the US Food and Drug Administration (FDA) in May 2019 as a tool for remotely monitoring patients ... Inc. (OTCQB: CYDY ) announced last week the results of the patient safety data from the Company's over-enrolled COVID-19 Phase 2 trial for mild-to-moderate indications. A total of 84 patients were treated ...