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INITIAL INVESTIGATIONAL NEW DRUG APPLICATION
This process is referred to as a “cross-reference”. FDA regulations provide that with authorization, information previously submitted to the FDA regarding chemistry, manufacturing, and control (CMC), as well as information regarding pharmacology and toxicity, may be incorporated by reference into a …
ind submission process

FDA Internal Standard Operating Procedures for the
Jun 26, 2020 · IND: Investigational New Drug. An IND application is the document submitted to the FDA for permission to conduct a clinical study using a drug or biologic that is new or not approved for a given dosage, formulation, or indication. When the FDA approves an IND application, it assigns an IND number to the specific use of the item.
investigational new drug exemption

[DOCX File]SOP FDA-Regulated Research
https://info.5y1.org/fda-ind-process_1_7777cf.html
If utilizing a drug that is currently subject to a manufacturer’s IND, or marketing application, refer to that IND or application or Drug Master File (if appropriate) to prevent duplicating information that are already available to FDA. Include a Letter of Authorization from the other sponsor permitting FDA to use their information for this IND.
investigational new drug fda

[DOC File]Investigational New Drug (IND) Submission checklist
https://info.5y1.org/fda-ind-process_1_d640d4.html
INITIAL INVESTIGATIONAL NEW DRUG APPLICATION . IND Title (if title being used) Serial 000 (Note to User: This template is intended for ‘simple’ INDs where commercially marketed drugs are being evaluated by sponsor-investigators.
ind modules

Investigational New Drug (IND) or Device Exemption (IDE) Process (…
The RIHSC will also inquire as to whether an IND/IDE is needed for a particular study and may ask the FDA sponsor to obtain an IND/IDE determination from the agency before RIHSC approval ...
investigational new drug ind application

Fda ind process