Information sheet : guidance for institutional review boards and clinical investigators (treatment use of investigational drugs).

Information sheet : guidance for institutional review boards and clinical investigators (recruiting study subjects).
Published: (1998)

Information sheet : guidance for institutional review boards and clinical investigators (screening tests prior to study enrollment).
Published: (1998)

Information sheet : guidance for institutional review boards and clinical investigators (cooperative research).
Published: (1998)

Information sheet : guidance for institutional review boards and clinical investigators (sponsor - investigator - IRB interrelationship).
Published: (1998)

Information sheet : guidance for institutional review boards and clinical investigators (frequently asked questions).
Published: (1998)

Information sheet : guidance for institutional review boards and clinical investigators (non-local IRB review).
Published: (1998)

Information sheet : guidance for institutional review boards and clinical investigators (continuing review after study approval).
Published: (1998)

Information sheet : guidance for institutional review boards and clinical investigators (a guide to informed consent).
Published: (1998)

Information sheet : guidance for institutional review boards and clinical investigators (acceptance of foreign clinical studies).
Published: (1998)

Information sheet : guidance for institutional review boards and clinical investigators (exception from informed consent for studies conducted in emergency settings; regulatory language and excerpts from preamble).
Published: (1998)

Guidance for clinical investigators, sponsors, and IRBs : adverse event reporting to IRBs : improving human subject protection.
Published: (2009)

Guidance for institutional review boards (IRBs) : frequently asked questions, IRB registration.
Published: (2009)

Guidance for industry : IRB review of stand-alone HIPAA authorizations under FDA regulations.
Published: (2003)

Guidance for industry : protecting the rights, safety and welfare of study subjects : supervisory responsibilities of investigators.
Published: (2007)

Information sheet guidance for sponsors, clinical investigators, and IRBs : frequently asked questions, statement of investigator (form FDA 1572).
Published: (2008)

Guidance for industry and clinical investigators : the use of clinical holds following clinical investigator misconduct.
Published: (2004)

Human subjects research : undercover tests show the institutional review board system is vulnerable to unethical manipulation : testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives /
by: Kutz, Gregory D.
Published: (2009)

Institutional review boards that oversee experimental human testing for profit : hearing before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred Eleventh Congress, first session, March 26, 2009.
Published: (2012)

Guidance for clinical investigators, institutional review boards, and sponsors : process for handling referrals to FDA under 21 CFR 50.54 : additional safeguards for children in clinical investigations.
Published: (2006)

Continued management concerns at the NIH : hearing before the Subcommittee on Oversight and Investigations of the Committee on Commerce, House of Representatives, One Hundred Fifth Congress, first session, July 19, 1997.
Published: (1997)

Institutional review boards in the U.S.-México border : current protocols and practices.
Published: (2010)

Protecting human subjects in research : are current safeguards adequate? : hearing before the Subcommittee on Public Health of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Seventh Congress, second session, on examining current safeguards concerning the protection of human subjects in research, while facilitating critical medical research, April 23, 2002.
Published: (2002)

Protecting human subjects in research : are current safeguards adequate? : hearing before the Subcommittee on Public Health of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Seventh Congress, second session, on examining current safeguards concerning the protection of human subjects in research, while facilitating critical medical research, April 23, 2002.
Published: (2002)

Guidance for industry : financial disclosure by clinical investigators.
Published: (2001)

Guidance for industry : IND exemptions for studies of lawfully marketed drug or biological products for the treatment of cancer.
Published: (2004)

Human subject research protections : hearing before the Subcommittee on Criminal Justice, Drug Policy, and Human Resources of the Committee on Government Reform, House of Representatives, One Hundred Sixth Congress, second session, May 3, 2000.
Published: (2001)

Right to try : hearing before the Committee on Homeland Security and Governmental Affairs, United States Senate, One Hundred Fourteenth Congress, second session : connecting patients to new and potential life saving treatments, February 25, 2016 ; exploring a right to try for terminally ill patients, September 22, 2016.
Published: (2017)

Guidance for industry : INDs for phase 2 and phase 3 studies, chemistry, manufacturing, and controls information.
Published: (2003)

Protecting human subjects training.
Published: (2012)

Current issues in human subject protection : an FDA perspective : September 13, 1996, Natcher Auditorium.
Published: (1996)

Use of commercial institutional review boards in sponsored research trials /

Guidance for industry : considerations for developmental toxicity studies for preventive and therapeutic vaccines for infectious disease indications.
Published: (2006)

Variations in medical practice : hearing before a subcommittee of the Committee on Appropriations, United States Senate, Ninety-eighth Congress, second session : special hearing.
Published: (1985)

Guidance for industry : IND meetings for human drugs and biologics, chemistry, manufacturing, and controls information.
Published: (2001)

Final report on low-volume institutional review boards.
Published: (1998)

Institutional review boards that oversee experimental human testing for profit : hearing before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred Eleventh Congress, first session, March 26, 2009.
Published: (2012)