Results 51 to 60 of about 1,046,073 (109)

Measurable residual disease (MRD) as a surrogate end point for clinical drug approval in acute myeloid leukemia (AML): Perspectives from the MRD Partnership and Alliance in AML Clinical Treatment Consortium. [PDF]

Cancer
Boyiadzis M, Wei AH, Paiva B, Freeman SD, Kaspers G, Chyla B, Hersey S, Patel R, Maloney B, Blanchet Zumofen MH, Van Hoef M, Wulff B, Obourn V, Patel S, Lopes de Menezes D, Shi Q, Bengoudifa BR, Dimier N, Prior TJ, Roboz GJ, Prebet T.   +20 more
europepmc   +1 more source

ChemAP: predicting drug approval with chemical structures before clinical trial phase by leveraging multi-modal embedding space and knowledge distillation. [PDF]

Sci Rep
Cho C, Lee S, Bang D, Piao Y, Kim S.
europepmc   +1 more source

Drug Approval for the Treatment of Geographic Atrophy: How We Got Here and Where We Need to Go. [PDF]

Am J Ophthalmol
Csaky KG, Miller JML, Martin DF, Johnson MW.   +3 more
europepmc   +1 more source

Magnitude of effect and sample size justification in trials supporting anti-cancer drug approval by the US Food and Drug Administration. [PDF]

Sci Rep
Nadler MB, Wilson BE, Desnoyers A, Valiente CM, Saleh RR, Amir E.   +5 more
europepmc   +1 more source

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Drug Approval and Drug Effectiveness

Annual Review of Clinical Psychology, 2014
Data on the efficacy and safety of psychiatric medicines should form the foundation of evidence-based treatment practices. The US Food and Drug Administration (FDA) reviews such data in determining whether to approve new treatments, and the published literature serves as a repository for evidence on treatment benefits and harms.
Glen I, Spielmans, Irving, Kirsch
openaire   +2 more sources

Drug approvals

The Nurse Practitioner, 2009
Gary Laustsen, Fernando Carrillo, Jessica Johnson, Cynthia Smith   +3 more
  +9 more sources

Drug Approval and Surveillance

International Journal of Gynecology & Obstetrics, 1980
ABSTRACTThe author proposes that current regulations governing the licensing of drugs, particularly in the United States, need to be changed and replaced by a system of provisional or conditional licensing and increased postmarketing surveillance of drug use.
openaire   +2 more sources

Approving new drugs

Science, 2017
As the Trump administration takes shape, there is much speculation as to what major changes will be made. A dominant theme of the Trump campaign was to cut through bureaucracy in Washington, D.C., thereby enhancing innovation and bringing new technology to Americans more quickly.
openaire   +2 more sources