Principles of Vaccine Licensure, Approval, and Recommendations for Use.
Sign Up to like & getrecommendations! Published in 2020 at "Mayo Clinic proceedings"
DOI: 10.1016/j.mayocp.2019.11.002
Abstract: The licensure and recommendation processes for vaccines are complex. In the United States, vaccines are licensed for the civilian and military populations on the basis of review of Biologics License Applications submitted to the Food… read more here.
Keywords: advisory committee; committee; principles vaccine; licensure ... See more keywords
Perspective: Impact of the National Academy of Sciences, Engineering, and Medicine Report on the Process for the 2020 Dietary Guidelines Advisory Committee.
Sign Up to like & getrecommendations! Published in 2021 at "Advances in nutrition"
DOI: 10.1093/advances/nmab023
Abstract: The National Academy of Sciences, Engineering, and Medicine (NASEM) recommended steps to redesign the process of developing the Dietary Guidelines for Americans (DGA) are based on 5 guiding principles (enhance transparency; promote diversity of expertise… read more here.
Keywords: medicine; advisory committee; dietary guidelines; process ... See more keywords
Update from the Advisory Committee on Immunization Practices
Sign Up to like & getrecommendations! Published in 2020 at "Journal of the Pediatric Infectious Diseases Society"
DOI: 10.1093/jpids/piaa144
Abstract: Abstract The Advisory Committee on Immunization Practices (ACIP), a group of medical and public health experts, normally meets 3 times per year to develop recommendations for vaccine use in the U.S. Because of the SARS-CoV-2… read more here.
Keywords: immunization practices; advisory committee; update advisory; committee immunization ... See more keywords
Anesthetic and Analgesic Drug Products Advisory Committee Activity and Decisions in the Opioid-crisis Era
Sign Up to like & getrecommendations! Published in 2020 at "Anesthesiology"
DOI: 10.1097/aln.0000000000003485
Abstract: The United States Food and Drug Administration is tasked with ensuring the efficacy and safety of medications marketed in the United States. One of their primary responsibilities is to approve the entry of new drugs… read more here.
Keywords: analgesic drug; drug products; drug; anesthetic analgesic ... See more keywords
Ten years of donor‐derived disease: A report of the disease transmission advisory committee
Sign Up to like & getrecommendations! Published in 2020 at "American Journal of Transplantation"
DOI: 10.1111/ajt.16178
Abstract: Despite clinical and laboratory screening of potential donors for transmissible disease, unexpected transmission of disease from donor to recipient remains an inherent risk of organ transplantation. The Disease Transmission Advisory Committee (DTAC) was created to… read more here.
Keywords: advisory committee; transmission; disease transmission; disease ... See more keywords
The advisory Committee on Immunization practices’ updated interim recommendation for allocation of COVID‐19 vaccine—United states, December 2020
Sign Up to like & getrecommendations! Published in 2021 at "American Journal of Transplantation"
DOI: 10.1111/ajt.16480
Abstract: This month’s MMWR selection is a link to the updated recommendations from the Advisory Committee on Immunization Practices regarding the allocation of COVID‐19 vaccine. read more here.
Keywords: advisory committee; covid vaccine; allocation covid; committee immunization ... See more keywords
Recommendations of the European Advisory Committee of Cytotechnology and European Federation of Cytology Societies for Training and Education of Cytotechnologists in Europe
Sign Up to like & getrecommendations! Published in 2021 at "Acta Cytologica"
DOI: 10.1159/000513899
Abstract: Background: Faced with changes in cytodiagnostics, cervical cancer screening programs, the introduction and application of new methods, the cytotechnological educational program requires the necessary changes and additions. Insufficient, uneven as well as inaccessible education of… read more here.
Keywords: cytotechnologists europe; advisory committee; european advisory; education cytotechnologists ... See more keywords
The Compassionate Use Advisory Committee (CompAC) for development of pre-approval access to investigational drugs.
Sign Up to like & getrecommendations! Published in 2017 at "Journal of Clinical Oncology"
DOI: 10.1200/jco.2017.35.15_suppl.e18001
Abstract: e18001Background: In May 2015, CompAC was formed at NYU to provide guidance fairly and transparently on allocating a limited supply of , Daratumumab, to patients outside of clinical trials. Janssen... read more here.
Keywords: advisory committee; compac; compassionate use; compac development ... See more keywords
Voting behavior during FDA Medical Device Advisory Committee panel meetings
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DOI: 10.1371/journal.pone.0267134
Abstract: Objectives During premarket review, the US Food and Drug Administration may ask its Medical Device Advisory Committee (MDAC) Panels to assess the safety and effectiveness of medical devices being considered for approval. The objective of… read more here.
Keywords: panel; device advisory; medical device; advisory committee ... See more keywords
Use of 15-Valent Pneumococcal Conjugate Vaccine and 20-Valent Pneumococcal Conjugate Vaccine Among U.S. Adults: Updated Recommendations of the Advisory Committee on Immunization Practices - United States, 2022.
Sign Up to like & getrecommendations! Published in 2022 at "MMWR. Morbidity and mortality weekly report"
DOI: 10.15585/mmwr.mm7104a1
Abstract: In 2021, 20-valent pneumococcal conjugate vaccine (PCV) (PCV20) (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.) and 15-valent PCV (PCV15) (Merck Sharp & Dohme Corp.) were licensed by the Food and Drug Administration for adults… read more here.
Keywords: valent pneumococcal; conjugate vaccine; pneumococcal conjugate; advisory committee ... See more keywords
Insights and issues from FDA Advisory Committee meetings on abuse-deterrent opioids.
Sign Up to like & getrecommendations! Published in 2017 at "Journal of opioid management"
DOI: 10.5055/jom.2017.0416
Abstract: It is the current policy of the US Food and Drug Administration (FDA) to convene expert Advisory Committees to provide input on key regulatory decisions regarding opioid products, including approval and labeling of opioid abuse-deterrent… read more here.
Keywords: advisory committee; advisory committees; abuse deterrent; committee meetings ... See more keywords