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Navegar por los elementos (4 total)
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Autor: FDA
Tema: Research
Tipo de elemento: Hipervínculo
Fecha de actualización: 2023-05-12
Descripción: The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear (CBRN) threats including infectious diseases, by facilitating the… -
Autor: FDA
Tema: Research
Tipo de elemento: Hipervínculo
Fecha de actualización: 2022-07-20
Descripción: Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators… -
Autor: FDA
Tema: Treatment & Care
Tipo de elemento: Guía
Fecha de actualización: 2022-04
Descripción: JYNNEOS is a vaccine indicated for prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.Includes: indications and usage, dosage and administration, dosage… -
Autor: FDA
Tema: Research
Tipo de elemento: Hipervínculo
Fecha de actualización: 2021-05
Descripción: Guidance for Sponsors, Clinical Investigators, and IRBs. Information for investigational new drugs (IND).
Draft Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA…
