WebIf the reference is made to supporting information already in the IND, the sponsor shall identify by name, reference number, volume, and page number the location of the information. (3) If the sponsor desires FDA to comment on the submission, a request for such comment and the specific questions FDA's response should address. (e) When … WebMay 17, 2011 · US FDA Regulations on IND Amendments SUBCHAPTER D--DRUGS FOR HUMAN USE Drug Information Association www.diahome.org 6 PART 312 -- INVESTIGATIONAL NEW DRUG APPLICATION Subpart B--Investigational New Drug Application (IND) Sec. 312.30 Protocol amendments. Sec. 312.31 Information amendments
CMC Requirements for an Investigational New Drug …
Web2 FDA Regulatory Authority Statutes – enacted by Congress Public Health Service Act Food Drug & Cosmetic Act Regulations – binding interpretations of law Code of Federal Regulations (CFR) 21 CFR 312 – Investigational New Drug Application (IND) Guidance – describes agency’s policy & regulatory approach to a specific area or issue Not binding on … Web☐Information Amendments ☐Notice to withdraw IND. Should include: ☐Corresponding 1571 documenting a change in serial number & describing the type of. submission (upload on top’ of previous 1571 (see IND Handout pg 3) ☐Documentation of FDA submission and the date. Timing - Submit the IRB modification at the time of the IND submission to ... shane x ryan rated m
21 CFR § 312.31 - Information amendments. Electronic Code of …
WebMar 18, 2024 · Amendments. The IND is often amended throughout its lifecycle. There are two types of IND amendments: Protocol Amendments and Information Amendments. Protocol amendments are to ensure that the clinical investigations are conducted according to the protocols included in the application (21 CFR 312.30). 19 Examples of protocol … Web• Changes during the course of the IND handled through a formal documented process, e.g., a Change Control Protocol, or similar mechanism, to cover, e.g., changes to: -Purity/quality of materials -Production process -Analytical testing procedures; limits … WebSubsequent amendments to the IND that contain new or revised protocols should build logically on previous submissions and should be supported by additional information, including the results of animal toxicology studies or other human studies as appropriate. ... If an IND is withdrawn, FDA shall be so notified, all clinical investigations ... shaney barratt