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Scientific and Regulatory Policy Committee Points to Consider: Review of the United States Food and Drug Administration (FDA) Guidance on Pathology Peer Review in Nonclinical Toxicology Studies.

• Authors : McDorman, Kevin S.¹ (AUTHOR) ; Bennet, Bindu M.² (AUTHOR); Colman, Karyn³ (AUTHOR)

Subjects: *TOXICOLOGY; *PATHOLOGY; *LABORATORY personnelUNITED States. Food & Drug Administration

• Source: Toxicologic Pathology. Feb2024, Vol. 52 Issue 2/3, p138-148. 11p.

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Comparing Generic and Innovator Drugs: A Review of 12 Years of Bioequivalence Data from the United States Food and Drug Administration.

• Source: Annals of Pharmacotherapy; Oct2009, Vol. 43 Issue 10, p1583-1597, 15p

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Safety and tolerability results of atogepant for the preventive treatment of episodic migraine from a 40-week, open-label multicenter extension of the phase 3 ADVANCE trial.

• Authors : Klein, Brad C¹ (AUTHOR) ; Miceli, Rosa² (AUTHOR); Severt, Lawrence² (AUTHOR)

Subjects: *CLINICAL trials; *CALCITONIN gene-related peptide; *RESPIRATORY infectionsUNITED States. Food & Drug Administration

• Source: Cephalalgia. Jan2023, Vol. 43 Issue 1, p1-11. 11p.

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Analysis of adverse events with sclerosants reported to the United States Food and Drug Administration.

• Authors : Nguyen, Christopher N; Nguyen, Quoc-Bao D; Silapunt, Sirunya

Subjects: ANAPHYLAXIS; CAUSES of death; PULMONARY embolismUNITED StatesUNITED States. Food & Drug Administration

• Source: Phlebology; Jul2022, Vol. 37 Issue 6, p452-459, 8p

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Adverse Events Related to Cartiva Hemiarthroplasty of First Metatarsal: An Analysis of Reports to the United States Food and Drug Administration.

• Authors : Metikala, Sreenivasulu; Mahmoud, Karim; O'Connor, Kathryn M.

• Source: Foot & Ankle Specialist; Apr2022, Vol. 15 Issue 2, p113-118, 6p

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Olanzapine-Samidorphan for Schizophrenia: A Systematic Review and Meta-Analysis.

• Authors : Gupta, Dhyuti¹ (AUTHOR); Singh, Alok² (AUTHOR)

Subjects: *WEIGHT gain; *SCHIZOPHRENIA; *OLANZAPINEUNITED States. Food & Drug Administration

• Source: Indian Journal of Psychological Medicine. Jan2024, Vol. 46 Issue 1, p14-23. 10p.

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Fatal neutropenic enterocolitis associated with docetaxel use: A review of cases reported to the United States Food and Drug Administration Adverse Event Reporting System.

• Authors : Singh, Pritpal; Nayernama, Afrouz; Christopher Jones, S

Subjects: CANCER chemotherapy; CAUSES of death; DRUG side effectsUNITED States. Food & Drug Administration; WORLD Health Organization

• Source: Journal of Oncology Pharmacy Practice; Jun2020, Vol. 26 Issue 4, p923-928, 6p, 2 Charts

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Education Full Text (H.W. Wilson)

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FDA jurisdiction over tobacco thrown into doubt by ruling.

• Authors : Freedman, Allan

Subjects: *TOBACCO industry; TOBACCO useUNITED States. Food & Drug Administration

• Source: CQ Weekly. 08/22/98, Vol. 56 Issue 34, p2286. 3p. 1 Black and White Photograph.

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FDA's drug approval process under a microscope again.

• Authors : Freedman, Allan; Benkelman, Susan

Subjects: UNITED States. Food & Drug Administration; PHARMACEUTICAL policyUNITED StatesUNITED StatesUNITED StatesReport Available

• Source: CQ Weekly. 07/18/98, Vol. 56 Issue 29, p1914. 5p. 4 Color Photographs, 2 Graphs.

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