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Management: Food and Drug Administration (FDA)
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Total 7481 results found since Jan 2013.
Neoadjuvant immunotherapy in resectable non-small cell lung cancer
Clin Adv Hematol Oncol. 2023 Aug;(8):415-423.ABSTRACTLung cancer is the leading cause of cancer-related deaths worldwide and is associated with poor 5-year outcomes, even among the 20% to 25% of patients who present with operable disease. Cisplatin-based adjuvant chemotherapy has long been the standard of care for patients with resected non-small cell lung cancer (NSCLC). With the incorporation of immunotherapy, however, the treatment paradigm for NSCLC has changed dramatically. The introduction of immune checkpoint blockade has improved clinical outcomes in multiple phase 2 and 3 trials in both the neoadjuvant and adjuvan...
Source: Clinical Lung Cancer - August 2, 2023 Category: Cancer & Oncology Authors: Sarah E Lochrin Patrick M Forde Source Type: research
Vaccination has more to offer than direct clinical benefit: FDA's vaccine licensure process ignores population health and social determinants of disease
Am J Epidemiol. 2023 Jul 31:kwad161. doi: 10.1093/aje/kwad161. Online ahead of print.ABSTRACTThe current U.S. Food and Drug Administration (FDA) licensure process underestimates the potential benefits of vaccines at both the individual and population levels by considering only direct clinical outcomes of vaccination. While all approved vaccines do protect the person who takes them from poor clinical outcomes for a specific infectious disease, many vaccines also have the potential to offer measurable, direct non-clinical benefits. For example, COVID-19 vaccinations for school-aged children may prevent school absenteeism. Al...
Source: Am J Epidemiol - August 1, 2023 Category: Epidemiology Authors: Malia Jones Katelyn K Jetelina Source Type: research
Analyte and matrix method extension of per- and polyfluoroalkyl substances in food and feed
Anal Bioanal Chem. 2023 Aug 2. doi: 10.1007/s00216-023-04833-1. Online ahead of print.ABSTRACTThe development and expansion of analytical methods for per- and polyfluoroalkyl substances (PFAS) in food are essential for the continued monitoring of the United States (US) food supply and assessments of dietary exposure. In March 2022, the European Union Reference Laboratory for Halogenated Persistent Organic Pollutants in Feed and Food (EURL POPs) released a guidance document covering priority PFAS of interest, including analytical method parameters and limits of quantification (LOQs). As a result, the Food and Drug Administr...
Source: Analytical and Bioanalytical Chemistry - August 1, 2023 Category: Chemistry Authors: Susan Genualdi Wendy Young Elsie Peprah Cynthia Srigley Christine M Fisher Brian Ng Lowri deJager Source Type: research
Vaccination has more to offer than direct clinical benefit: FDA's vaccine licensure process ignores population health and social determinants of disease
Am J Epidemiol. 2023 Jul 31:kwad161. doi: 10.1093/aje/kwad161. Online ahead of print.ABSTRACTThe current U.S. Food and Drug Administration (FDA) licensure process underestimates the potential benefits of vaccines at both the individual and population levels by considering only direct clinical outcomes of vaccination. While all approved vaccines do protect the person who takes them from poor clinical outcomes for a specific infectious disease, many vaccines also have the potential to offer measurable, direct non-clinical benefits. For example, COVID-19 vaccinations for school-aged children may prevent school absenteeism. Al...
Source: Am J Epidemiol - August 1, 2023 Category: Epidemiology Authors: Malia Jones Katelyn K Jetelina Source Type: research
United States Food and Drug Administration Regulation of Human Cells, Tissues, and Gene Therapies
Adv Exp Med Biol. 2023;1430:71-89. doi: 10.1007/978-3-031-34567-8_5.ABSTRACTResearch and development of gene therapies and cell- or tissue-based therapies has experienced exponential growth in recent decades and the potential for these products to treat diverse, often rare, clinical indications is promising. The Office of Therapeutic Products (OTP) in the Center for Biologics Evaluation and Research (CBER) at the United States Food and Drug Administration (US FDA) is responsible for the regulation of these products, among others, throughout the entire product lifecycle. This chapter provides an overview of the science- and...
Source: Adv Data - August 1, 2023 Category: Epidemiology Authors: Sandhya Sanduja Liz Lessey-Morillon Rondine Allen Xiaofei Wang Gavin Imperato Judith Arcidiacono Source Type: research
Vaccination has more to offer than direct clinical benefit: FDA's vaccine licensure process ignores population health and social determinants of disease
Am J Epidemiol. 2023 Jul 31:kwad161. doi: 10.1093/aje/kwad161. Online ahead of print.ABSTRACTThe current U.S. Food and Drug Administration (FDA) licensure process underestimates the potential benefits of vaccines at both the individual and population levels by considering only direct clinical outcomes of vaccination. While all approved vaccines do protect the person who takes them from poor clinical outcomes for a specific infectious disease, many vaccines also have the potential to offer measurable, direct non-clinical benefits. For example, COVID-19 vaccinations for school-aged children may prevent school absenteeism. Al...
Source: Am J Epidemiol - August 1, 2023 Category: Epidemiology Authors: Malia Jones Katelyn K Jetelina Source Type: research
Seeing Colchicine in a New Light: Repurposing Low-Dose Colchicine for Secondary Prevention of Cardiovascular Disease
This article presents a brief overview of colchicine's long history as a medicine, as well as a critical review of safety and efficacy from the results of recent cardiovascular clinical trials.FINDINGS: Long-term continuous colchicine use at doses between 0.6 and 2.4 mg has been used to prevent inflammatory flares in patients with gout and familial Mediterranean fever and less commonly employed in a range of other inflammatory conditions. In these settings, lifelong therapy has been found to be safe and well tolerated. Understanding the central role of inflammation in atherosclerosis has led to the search for effective ant...
Source: Atherosclerosis - July 29, 2023 Category: Cardiology Authors: Stefan Mark Nidorf Source Type: research
Early Emergency Department Experience with 7-day Extended-Release Injectable Buprenorphine for Opioid Use Disorder
We report our early experiences with this medication, (investigational drug CAM2038) in the context of an ongoing clinical trial entitled, Emergency Department-Initiated BUP VAlidaTION (ED INNOVATION), to inform emergency clinicians as they consider incorporating this medication into their practice. The medication was approved by the European Medicines Agency in 2018 and the U.S. Food and Drug Administration in 2023 for those 18 years or older for the treatment of moderate to severe opioid use disorder (OUD). We report our experience with approximately 800 ED patients with opioid use disorder (OUD) who received the 7-day X...
Source: Accident and Emergency Nursing - July 28, 2023 Category: Emergency Medicine Authors: Gail D'Onofrio Jeanmarie Perrone Kathryn F Hawk Ethan Cowan Ryan McCormack Edouard Coupet Patricia H Owens Shara H Martel Kristen Huntley Sharon L Walsh Michelle R Lofwall Andrew Herring ED-INNOVATION Investigators Source Type: research
Demographic Disparities in Mpox Vaccination Series Completion, by Route of Vaccine Administration - California, August 9, 2022-March 31, 2023
MMWR Morb Mortal Wkly Rep. 2023 Jul 28;72(30):827-832. doi: 10.15585/mmwr.mm7230a4.ABSTRACTIn August 2022, the Food and Drug Administration authorized JYNNEOS vaccine (modified vaccinia Ankara vaccine, Bavarian Nordic), a 2-dose series used for the prevention of Monkeypox virus infection, to be administered via a dose-sparing intradermal route, in addition to the previously authorized subcutaneous route. The California Department of Public Health investigated whether demographic disparities in vaccination series completion varied by route of administration of the recipient's first dose. Among California residents who recei...
Source: MMWR Morb Mortal Wkl... - July 27, 2023 Category: Epidemiology Authors: Tarek Salih Josh Vance Joshua Quint Brenda Meza Louise McNitt Webster U Lincoln Robert Schechter Source Type: research
