Title 21 - Food and Drugs last revised: Nov 23, 2016 Collapse to view only § - General requirements for use of an investigational new drug in a clinical.
- General requirements for use of an investigational new drug in a clinical investigation. § - Comment and advice on an IND. § - Clinical Subpart A--General Provisions · Subpart B--Investigational · CFR 312. · Subpart I.
IND for that investigation is in effect (21 CFR). NAME OF SPONSOR. DATE OF SUBMISSION. ADDRESS (Number, Street, City, State and Zip Code). The minutes along with any other written material provided to the sponsor will serve as a permanent record of any agreements reached. FDA may place an expanded access IND or expanded access protocol on clinical hold under the following conditions:. Federal Rules of Civil Procedure. Not beginning a clinical investigation until an IND or IDE is in effect is a longstanding FDA policy that is enforced in support of the regulations I mentioned above so I am not aware that additional guidance is necessary. FDA will make every attempt to grant requests for 21 cfr 312.40 that involve important 21 cfr 312.40 and the 7 deadly sins games online can be scheduled at mutually convenient times. United States Code U. Except as provided in paragraph d of this section, a termination certification 5dimes eu sportsbook be preceded by a proposal to terminate by FDA and an opportunity for the sponsor to respond.