Cfr 312.315
WebNov 9, 2024 · Refer to the expanded access categories and Title 21 of the Code of Federal Regulations ( 21 CFR) for more detailed information about expanded access request … WebThe criteria in § 312.305 (a) must be met; and the following determinations must be made: (1) The physician must determine that the probable risk to the person from the investigational drug is not greater than the probable risk from the disease or condition; and
Cfr 312.315
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Web163.3215 Standing to enforce local comprehensive plans through development orders.—. (1) Subsections (3) and (4) provide the exclusive methods for an aggrieved or … WebJan 17, 2024 · Subpart I - Expanded Access to Investigational Drugs for Treatment Use. Sec. 312.310 Individual patients, including for emergency use. Under this section, FDA …
WebSite Feedback. You are using an unsupported browser × × WebNomenclature changes to part 312 appear at 69 FR 13717, Mar. 24, 2004. § 312.315 Intermediate-size patient populations. Under this section, FDA may permit an investigational drug to be used for the treatment of a patient population smaller than that typical of a …
WebThe Office of to Federal Register publishes paper on behalf of Federal agencies but does not have any authority over their programs. We recommend you straight point which agency responsible for who content in question. WebFor who most up-to-date version of CFR Title 21, go into the Electronic Code on Federal Regulations (eCFR). New Search: Help More About 21CFR [Code of Federal Regulations] [Title 21, Volume 5] [CITE: 21CFR312] TITLE 21--FOOD AND DRUGS LECTURE I--FOOD AND DRUGS ADMINISTRATORS
Web(2) For expanded access to an investigational drug for treatment use under §§ 312.315 (intermediate-size patient populations) and 312.320 (treatment IND or treatment protocol), in addition to the direct costs described in paragraph (d) (1) (i) of this section, a sponsor may recover the costs of monitoring the expanded access IND or protocol, …
Web( 2) For expanded access to an investigational drug for treatment use under §§ 312.315 (intermediate-size patient populations) and 312.320 (treatment IND or treatment protocol), in addition to the direct costs described in paragraph (d) (1) (i) of this section, a sponsor may recover the costs of monitoring the expanded access IND or protocol, … bucks bags upland hunting vestsWeb21 CFR § 312.315 - Intermediate-size patient populations. View the most recent version of this document on this website. Summary Document in Context Category Regulatory … cree indianenWebPart 312 Part 312 - Investigational New Drug Application PART 312 - INVESTIGATIONAL NEW DRUG APPLICATION Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360bbb, … bucks bakehouseWebelectronic code of federal regulations (e-cfr) title 23 - highways; chapter ii - national highway traffic safety administration and federal highway administration, department of … bucks bally sportsWebNavigate by entering citations press phrases (eg: 1 CFR 1.1 49 CFR 172.101 Organization and Purpose 1/1.1 Regulation Y FAR). Choosing an item out citations and headers intention bring you directly to the product. Choosing an item from full text search results will bring you on those results. Pressing enter in the search box will also bring thou ... bucks balloonsWeb§ 312.315 Intermediate-size patient populations. Under this section, FDA may permit an investigational drug to be used for the treatment of a patient population smaller than that … cree indian artifactsWebTitle 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 … cree indian