Cfr 312.310
Web21 CFR 312.315 • Intended for situations where multiple patients with the same condition might benefit from a particular investigational product • No set numerical parameters – meant to be practical – more than a few, and less than a lot ; 33 ; …
Cfr 312.310
Did you know?
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 ... 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
WebTherefore, consistent with 21 CFR 312.10, FDA intends to consider a completed Form FDA 3926 with the box in Field 10 checked, to be a request for a waiver of any additional requirements in 21 CFR part 312 for an IND submission. FORM FDA 3926 SUPPLEMENT (3/16) – FORM INSTRUCTIONS Page 3 of 3 Web12 CFR Part 310 - PRIVACY ACT REGULATIONS. § 310.1 Purpose and scope. § 310.2 Definitions. § 310.3 Procedures for requests pertaining to individual records in a system …
WebJan 17, 2024 · (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... WebUnder 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.
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.
WebGiven 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... jeep look alike carsWebDisplaying title 21, up to date as of 4/05/2024. Title 21 was last amended 4/05/2024. There have been changes in the last two weeks to Part 312. Scope. Applicability. Definitions and interpretations. Labeling of an investigational new drug. Promotion of investigational drugs. Charging for investigational drugs under an IND. lagu indonesia hits sepanjang masaWebJan 17, 2024 · § 312.310 - Individual patients, including for emergency use. § 312.315 - Intermediate-size patient populations. § 312.320 - Treatment IND or treatment protocol. … jeep lucenaWebplaced 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 lagu indonesia hits di malaysiaWeb312.305 Requirements for all expanded access uses. § 312.305 Requirements for all expanded access uses. The criteria, submission requirements, safeguards, and … lagu indonesia diciptakan olehWeb§ 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 … lagu indonesia flac lengkapWeb312.10 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 … jeep love and aroma