The Food and Drug Administration's (FDA's) Drug Safety Surveillance During the COVID-19 Pandemic.

Autor: Diak IL; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA. Ida-Lina.Diak@fda.hhs.gov., Swank K; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., McCartan K; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Beganovic M; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Kidd J; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Gada N; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Kapoor R; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Wolf L; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Kangas L; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Wyeth J; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Salvatore T; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Fanari M; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., LeBoeuf AA; Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Mishra P; Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Blum MD; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Dal Pan G; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

Publikováno v: Drug safety [Drug Saf] 2023 Feb; Vol. 46 (2), pp. 145-155. Date of Electronic Publication: 2022 Dec 02.

Good manufacturing practice inspections conducted by Tanzania medicines and medical devices authority: a comparative study of two fiscal years from 2018 to 2020.

Autor: Sangeda, Raphael Zozimus¹ (AUTHOR) sangeda@gmail.com, Ndabatinya, Chimpaye Julius² (AUTHOR), Maganga, Maganga Bundala² (AUTHOR), Nkiligi, Emmanuel Alphonce² (AUTHOR), Mwalwisi, Yonah Hebron² (AUTHOR), Fimbo, Adam Mitangu² (AUTHOR)

Publikováno v: Journal of Pharmaceutical Policy & Practice. Dec2024, Vol. 17 Issue 1, p1-19. 19p.

Integrated Safety and Efficacy Analyses of Phase 3 Trials of a Microbiome Therapeutic for Recurrent CDI.

Autor: Kraft, Colleen S.¹ (AUTHOR), Sims, Matthew^2,3 (AUTHOR), Silverman, Michael⁴ (AUTHOR), Louie, Thomas J.⁵ (AUTHOR), Feuerstadt, Paul^6,7 (AUTHOR), Huang, Edward S.⁸ (AUTHOR), Khanna, Sahil⁹ (AUTHOR), Berenson, Charles S.¹⁰ (AUTHOR), Wang, Elaine E. L.¹¹ (AUTHOR), Cohen, Stuart H.¹² (AUTHOR), Korman, Louis¹³ (AUTHOR), Lee, Christine¹⁴ (AUTHOR), Kelly, Colleen R.¹⁵ (AUTHOR), Odio, Alberto¹⁶ (AUTHOR), Cook, Paul P.¹⁷ (AUTHOR), Lashner, Bret¹⁸ (AUTHOR), Ramesh, Mayur¹⁹ (AUTHOR), Kumar, Princy²⁰ (AUTHOR), De, Ananya¹¹ (AUTHOR), Memisoglu, Asli¹¹ (AUTHOR)

Publikováno v: Infectious Diseases & Therapy. Oct2024, Vol. 13 Issue 10, p2105-2121. 17p.

Amylose starch with no detectable branching developed through DNA-free CRISPR-Cas9 mediated mutagenesis of two starch branching enzymes in potato.

Autor: Zhao X; Department of Molecular Sciences, Swedish University of Agricultural Sciences, Box 7015, 750 07, Uppsala, Sweden., Jayarathna S; Department of Molecular Sciences, Swedish University of Agricultural Sciences, Box 7015, 750 07, Uppsala, Sweden., Turesson H; Department of Plant Breeding, Swedish University of Agricultural Sciences, P.O. Box 101, 23053, Alnarp, Sweden., Fält AS; Department of Plant Breeding, Swedish University of Agricultural Sciences, P.O. Box 101, 23053, Alnarp, Sweden., Nestor G; Department of Molecular Sciences, Swedish University of Agricultural Sciences, Box 7015, 750 07, Uppsala, Sweden., González MN; Consejo Nacional de Investigaciones Científicas Y Técnicas, (C1425FQB), Buenos Aires, Argentina.; Laboratorio de Agrobiotecnología, IPADS (INTA - CONICET), Ruta 226, Km 73.5, B7620, Balcarce, Argentina., Olsson N; Department of Plant Breeding, Swedish University of Agricultural Sciences, P.O. Box 101, 23053, Alnarp, Sweden., Beganovic M; Department of Plant Breeding, Swedish University of Agricultural Sciences, P.O. Box 101, 23053, Alnarp, Sweden., Hofvander P; Department of Plant Breeding, Swedish University of Agricultural Sciences, P.O. Box 101, 23053, Alnarp, Sweden., Andersson R; Department of Molecular Sciences, Swedish University of Agricultural Sciences, Box 7015, 750 07, Uppsala, Sweden., Andersson M; Department of Plant Breeding, Swedish University of Agricultural Sciences, P.O. Box 101, 23053, Alnarp, Sweden. mariette.andersson@slu.se.

Publikováno v: Scientific reports [Sci Rep] 2021 Feb 22; Vol. 11 (1), pp. 4311. Date of Electronic Publication: 2021 Feb 22.

Fluoroquinolone versus Beta-Lactam Oral Step-Down Therapy for Uncomplicated Streptococcal Bloodstream Infections.

Autor: Arensman K; Department of Pharmacy, Advocate Lutheran General Hospital, Park Ridge, Illinois, USA., Shields M; Russell Center for Research and Innovation, Park Ridge, Illinois, USA., Beganovic M; Department of Pharmacy, Advocate Lutheran General Hospital, Park Ridge, Illinois, USA., Miller JL; Department of Pharmacy, Advocate South Suburban Hospital, Hazel Crest, Illinois, USA.; Department of Pharmacy, Advocate Trinity Hospital, Chicago, Illinois, USA., LaChance E; Department of Pharmacy, Advocate Illinois Masonic Medical Center, Chicago, Illinois, USA., Anderson M; Department of Pharmacy, Advocate Condell Medical Center, Libertyville, Illinois, USA.; Department of Pharmacy, Advocate Good Shepherd Hospital, Barrington, Illinois, USA., Dela-Pena J; Department of Pharmacy, Advocate Lutheran General Hospital, Park Ridge, Illinois, USA jennifer.delapena@aah.org.

Publikováno v: Antimicrobial agents and chemotherapy [Antimicrob Agents Chemother] 2020 Oct 20; Vol. 64 (11). Date of Electronic Publication: 2020 Oct 20 (Print Publication: 2020).