A dietary supplement or substance generally recognized as safe (GRAS) that will be used to (list in Item 26) diagnose, cure mitigate, treat or prevent disease A Device (list in Item 27) Item 26 List all protocol directed Select one status choices below Additional IND Information items below a) b) c) d) e) f) List the directed by FDA Used in Will study data be Status of IND Name of the IND this protocol Approved? accordance submitted to or held Holder (Sponsor) Insert one of the with FDA for inspection by the following: Insert the following for each Insert either: approved FDA for approval or Submitted on drug: Yes If the IND is held by a labeling? a change in labeling, (insert date) Name (trade and local investigator, No marketing or Approved (insert submit an Inst-H with generic), Insert advertising? Step 2. IND number and Dosage, either: (any time now or in the include FDA IND Route of Yes future) letter) administration No Insert either: Exempt from IND N/A (no Yes Submit ) Submit a for VA only (not required FDA- – – for UT or UHS) approved No N/A Submit FDA labeling) approved package insert/ IB To add rows use copy & paste Insert response here Insert Insert Insert response Insert response Insert response response response here here here here here Item 27 List all protocol directed Select one status choices Additional IDE Information items below a) b) c) d) e) f) g) List the Devices directed FDA Used in Is the device Will data Status of IDE Name of the IDE by this protocol Approved? accordance being tested be submitted Holder (Sponsor) Insert either: with FDA for safety to or held for Submitted to Insert the following for each Insert either: approved and/or inspection by FDA on (insert device: Yes If the IDE is held by labeling? effectiveness? the FDA for date) a local No approval or a investigator, Name (trade and Approved HUD (used Insert Insert either: change in submit an Inst-H generic) (insert IDE in clinical either: Yes labeling, with Step 2. Yes number and No marketing or No submit FDA advertising? N/A IDE letter) (any time now (no FDA- Exempt from or in the future) approved IDE labeling) Submit FDA Insert either: submission to approved Yes FDA Submit ) package – No N/A insert/ Device To add rows use copy & Manual
A dietary supplement or substance generally recognized as safe (GRAS) that will be used to diagnose, cure mitigate, treat or prevent disease (list in Item 26) A Device (list in Item 27) Item 26 List all protocol directed items below Select one status choices below Additional IND Information a) List the directed by this protocol Insert the following for each drug: Name (trade and generic), Dosage, Route of administration Submit a – for VA only (not required for UT or UHS) To add rows use copy & paste b) FDA Approved? Insert either: Yes No Submit FDA approved package insert/ IB c) Used in accordance with FDA approved labeling? Insert either: Yes No N/A (no FDA- approved labeling) d) Will study data be submitted to or held for inspection by the FDA for approval or a change in labeling, marketing or advertising? (any time now or in the future) Insert either: Yes No e) Status of IND Insert one of the following: Submitted on (insert date) Approved (insert IND number and include FDA IND letter) Exempt from IND – Submit ) N/A f) Name of the IND Holder (Sponsor) If the IND is held by a local investigator, submit an Inst-H with Step 2. Insert response here Insert response here Insert response here Insert response here Insert response here Insert response here Item 27 List all protocol directed items below Select one status choices Additional IDE Information a) List the Devices directed by this protocol Insert the following for each device: Name (trade and generic) To add rows use copy & b) FDA Approved? Insert either: Yes No HUD (used in clinical Submit FDA approved package insert/ Device Manual c) Used in accordance with FDA approved labeling? Insert either: Yes No N/A (no FDA- approved labeling) d) Is the device being tested for safety and/or effectiveness? Insert either: Yes No e) Will data be submitted to or held for inspection by the FDA for approval or a change in labeling, marketing or advertising? (any time now or in the future) Insert either: Yes No f) Status of IDE Insert either: Submitted to FDA on (insert date) Approved (insert IDE number and submit FDA IDE letter) Exempt from IDE submission to FDA – Submit ) N/A g) Name of the IDE Holder (Sponsor) If the IDE is held by a local investigator, submit an Inst-H with Step 2.