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Protection of Human Subjects; Informed Consent; Proposed Rule
… in the absence of informed consent. A May 23, 1994, hearing of the Subcommittee on Regulation, Business … Representatives from NIH and FDA testifying at the hearing acknowledged the need to further examine the issue of … responsibility being placed on IRB's. At the congressional hearing and at the Public Forum, some individuals expressed …
Protection of Human Subjects; Informed Consent
… 16, 1979. The comments received at the hearings and the hearing transcripts were made a part of the record of this … are on file in the Dockets Management Branch (formerly the Hearing Clerk's office) along with the written comments …
OWH Staff Publications
… International J of Toxic 2001; 20:149–152 T Toigo Hearing the cry for help and information FDA Consumer 2001, …
Implementing Alternative Methods
… Offices, has also held public events including a public hearing in 2018, and a public workshop in 2019. The …
Proposed New Drug, Antibiotic, and Biologic Drug Product Regulations: page 2
… provide the sponsor with an opportunity for a regulatory hearing before FDA Under Part 16 on the question of whether … be terminated. The sponsor's request for a regulatory hearing must be made within 10 days of the sponsor's receipt … will afford the sponsor an opportunity for a regulatory hearing under Part 16 on the question of whether the IND …
Protection of Human Subjects; Informed Consent, Exception From General Requirements
… 1994, United States Senate Committee on Veterans' Affairs hearing on "Is Military Research Hazardous to Veterans' …
Medical Devices; Humanitarian Use Devices Part V
… provide the applicant with notice and an opportunity for a hearing as required for PMA's under § 814.46(c) and (d), and …
Protection of Human Subjects; Informed Consent Part II 61 FR 51498
… Conducted in Emergency Circumstances, at a congressional hearing, and in various articles. The agency received no …
Proposed New Drug, Antibiotic, and Biologic Drug Product Regulations
… it will give the sponsor an opportunity for a regulatory hearing under 21 CFR Part 16 of FDA's administrative practice …
Protection of Human Subjects; Informed Consent and Waiver of Informed Consent Requirements in Certain Emergency Research
… Conducted in Emergency Circumstances, at a congressional hearing, and in various articles. The agency received no …