Cfr 312.310
WebOct 5, 2024 · A U.S. Food and Drug Administration (FDA) regulation called "expanded access"—technically known as 21 CFR 312.310 —allows physicians to request "compassionate use" of experimental treatments through an "investigational new drug" pathway used for individual patients or for emergencies. WebSep 9, 2024 · Criteria: 21 CFR 312.310 (a) Drug status: The patient cannot obtain the drug under another IND or protocol ( 21 CFR 312.310 (a) ). University of Utah Guidance Single Patient Non-Emergency Use Criteria: 21 CFR 312.310 (a); the patient has a serious condition and is not in an immediately life-threatening situation
Cfr 312.310
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WebJun 25, 2013 · FDA believes this regulation means that it is appropriate to request individual patient access using the emergency procedures described in 21 CFR 312.310 (d) when treatment of the patient must occur within a very limited number of hours or days. Web§ 312.310 Individual patients, including for emergency use. Under this section, FDA may permit an investigational drug to be used for the treatment of an individual patient by a …
WebJan 17, 2024 · Sec. 312.310 Individual patients, including for emergency use. Under this section, FDA may permit an investigational drug to be used for the treatment of an … Web§ 312.310 Individual patients, including for emergency use. Under this section, FDA may permit an investigational drug to be used for the treatment of an individual patient by a …
WebSerious adverse event means an adverse event that results in any of the following outcomes: Death, a life-threatening adverse event as defined in 21 CFR 312.32, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or … WebAfter normal working hours (8 a.m. to 4:30 p.m.), the request should be directed to the FDA Emergency Call Center, 866-300-4374, e-mail: [email protected]. (2) The licensed physician or sponsor must explain how the expanded access use will meet the requirements of §§ 312.305 and 312.310 and must agree to submit an expanded ...
Web§ 312.310 Individual patients, including for emergency use. Under this section, FDA may permit an investigational drug to be used for the treatment of an individual patient by a licensed physician. ( a) Criteria. The criteria in § 312.305 (a) must be met; and the …
Web312.10 Definitions. § 312.10 Definitions. (a) Terms used in this part and not defined below, but defined in either CERCLA or 40 CFR part 300 (the National Oil and Hazardous … geforce experience gtx 1060WebNavigate by entering citations or phrases (eg: 1 CFR 1.1 49 CFR 172.101 Organization and Purpose 1/1.1 Regulation Y FAR). Choosing an item from citations and headings will bring you directly to the content. Choosing an item from full text search results will bring you to those results. Pressing enter in the search box will also bring you to ... geforce experienceguanwangWebUnder the applicable criteria in 21 CFR 312.310 (a), the physician must determine that the probable risk to the person from the investigational drug/biologic is not greater than the probable risk from the disease or condition; and the FDA must determine that the patient cannot obtain the investigational drug/biologic under another IND or protocol. dc home health agencyWebplaced on inactive status (21 CFR 312.45(d)); or, terminated by FDA (21 CFR 312.44(d)) Annual Report : A brief report of the progress of the investigation submitted within 60 days of the dc homeless newsWebGiven the public health emergency that the COVID-19 pandemic presents, FDA is continuing to facilitate access to investigational convalescent plasma through the process of a physician requesting a... geforce experience gtx 650 downloadWeb• Individual Patient IND, including Emergency Use IND [21 CFR 312.310 ] - commonly held by treating physician or investigator for treatment of an individual patient. See FDA Individual Patient Expanded Access Application Instru ctions. FDA developed Form FDA 3926 specifically for Individual Patient IND request. geforce experience gtx 650Web(i) Expanded access use under the emergency procedures described in § 312.310 (d) may begin when the use is authorized by the FDA reviewing official. (ii) Expanded access use under § 312.320 may begin 30 days after FDA receives the protocol or upon earlier notification by FDA that use may begin. (3) Clinical holds. dc home health aide agencies