Cfr 312.315
WebInvestigational New Drug Application (IND) has the meaning given in 21 CFR 312.3. NCT number means the unique identification code assigned to each record in ClinicalTrials.gov, including a record for an applicable clinical trial, a clinical trial, … Web§ 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 …
Cfr 312.315
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Web§ 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 treatment IND or treatment protocol. 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 …
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, … WebThis subpart contains the requirements for the use of investigational new drugs and approved drugs where availability is limited by a risk evaluation and mitigation …
WebUnder this section, FDA may permit an investigational drug to be used for the treatment of a patient population smaller than that typical of a treatment IND or treatment protocol. FDA … 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 …
WebAvailable the most up-to-date software of CFR Song 21, go to the Electronic Code of Us Regulations (eCFR). New Search: Help More About 21CFR [Code of Federal Regulations] [Title 21, Band 5] [CITE: 21CFR312.30] TITLE 21--FOOD AND DRUGS: CHAPTER I--FOOD AND DRUG MANAGEMENT
WebJan 17, 2024 · (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... large zip plastic bagsWebNov 9, 2024 · Expanded Access Forms page. The .gov means it’s official. Federal government websites often end in .gov or .mil. hennef soccer halleWeb163.3215 Standing to enforce local comprehensive plans through development orders.—. (1) Subsections (3) and (4) provide the exclusive methods for an aggrieved or … l arginine and l lysine togetherWeb§1203. Preemption of Federal standards (a) Standards or regulations designed to protect against same risk as State standards or regulations; identical State standards hennef piercerWeb(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, … hennef reutherstrasse 2Web21 CFR § 312.315 - Intermediate-size patient populations. View the most recent version of this document on this website. Summary Document in Context Category Regulatory … hennef psychosomatikWebNov 9, 2024 · Expanded Access Forms sheet. The .gov signifies it’s official. Federal government websites frequent exit in .gov or .mil. large yellow planter pots