Results 201 to 210 of about 690,240 (260)

Requirements and special considerations for drug trials with children across six jurisdictions: 1. Clinical trial application review in the regulatory approval process. [PDF]

Front Med (Lausanne)
Stewart B, Lepola P, Egger GF, Ali F, Allen AJ, Croker AK, Davidson AJ, Dicks P, Faust SN, Green D, Hovinga C, Klein AV, Langham R, Nakamura H, Pioppo L, Ramroop S, Sakiyama M, Sanchez Vigil de la Villa I, Sato J, Snyder DL, Turner MA, Zaidi S, Zimmerman K, Lacaze-Masmonteil T.   +23 more
europepmc   +1 more source

Drug safety in healthy aging. [PDF]

NPJ Aging
Panajotovikj N, Fernández-Torras A, Mestres J.   +2 more
europepmc   +1 more source

Investigation of Lead and Chromium Exposure After Consumption of Contaminated Cinnamon-Containing Applesauce - United States, November 2023-April 2024. [PDF]

MMWR Morb Mortal Wkly Rep
Troeschel AN, Buser MC, Winquist A, Ruckart P, Yeh M, Kuai D, Chang A, Pennington AF, Rumph JT, Smith MR, Lara MV, Cataldo N, Lewis K, Arnold K, Harris S, Nicholas DC, Hughes M, Wortmann T, Norman E, Napier MD, Dillard J, Daniel J.   +21 more
europepmc   +1 more source

Proton Pump Inhibitor Use Exceeding the U.S. Food and Drug Administration Approved Treatment Duration for Patients With Peptic Ulcer Disease: A Retrospective Cohort Study. [PDF]

Pharmacoepidemiol Drug Saf
Villars JA, Anderson TS, Yabes JG, Schoen RE, Vajravelu RK.   +4 more
europepmc   +1 more source

United States Food and Drug Administration Drug Approval Summary [PDF]

Clinical Cancer Research, 2004
Abstract On May 5, 2003, gefitinib (Iressa; ZD1839) 250-mg tablets (AstraZeneca Inc.) received accelerated approval by the United States Food and Drug Administration as monotherapy for patients with locally advanced or metastatic non-small cell lung cancer after failure of both platinum-based and docetaxel chemotherapies.
Richard T. Lostritto, David L. Morse, Grant A. Williams, Sophia Abraham, Rajeshwari Sridhara, W. David McGuinn, Chenyi Liang, Atiqur Rahman, Amy Baird, Martin H. Cohen, Gang Chen, Richard Pazdur   +11 more
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Oncology drug development: United States Food and Drug Administration perspective

Critical Reviews in Oncology/Hematology, 2002
The Food and Drug Administration (FDA) in the United States has multiple roles. The primary responsibilities for oncology drug products are the supervision of clinical research, the evaluation of marketing claims for new and previously approved drugs, the granting of exclusive marketing licenses for approved claims, and the monitoring of post-marketing
Steven Hirschfeld, Richard Pazdur
openaire   +3 more sources

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

Phlebology: The Journal of Venous Disease, 2022
Objectives To analyze adverse events (AEs) related to sclerosants reported through the Federal Adverse Event Reporting System (FAERS). Methods We queried the FAERS database for all cases associated with sclerosants. Reports were analyzed and stratified based on severity of cases and patient death.
Christopher N Nguyen, Quoc-Bao D Nguyen, Sirunya Silapunt   +2 more
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End Points and United States Food and Drug Administration Approval of Oncology Drugs

Journal of Clinical Oncology, 2003
Purpose: To summarize the end points used by the United States Food and Drug Administration (FDA) to approve new cancer drug applications over the last 13 years. Materials and Methods: The FDA granted marketing approval to 71 oncology drug applications between January 1, 1990, and November 1, 2002.
John R. Johnson, Grant A. Williams, Richard Pazdur   +2 more
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Retrospective analysis of adverse events with dupilumab reported to the United States Food and Drug Administration

Journal of the American Academy of Dermatology, 2021
Atopic dermatitis (AD) is one of the most common inflammatory skin diseases and has aesthetic, physical, and emotional-social sequelae when left untreated.To classify the most common adverse reactions associated with dupilumab treatment in patients with AD.The United States Food and Drug Administration Adverse Event Reporting (FAERS) database was ...
Joseph L. Jorizzo, Joseph L. Jorizzo, Yu Wang   +2 more
openaire   +3 more sources