G. Hendriks schreef op 15 december 2023 16:02:
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Dat de nieuwe studie onder de bestaande NDA plaatsvindt, lees ik als: er is geen nieuwe NDA nodig ofwel de studie is vrijgesteld van een NDA. De FDA omschrijft nauwkeurig wanneer dat het geval kan zijn:
Whether an IND is needed to conduct a clinical investigation of a marketed drug primarily
depends on the intent of the investigation and the degree of risk associated with the use of the
drug in the investigation. A clinical investigation of a marketed drug is exempt from the IND
requirements if all of the criteria for an exemption in § 312.2(b) are met:
• The drug product is lawfully marketed in the United States.
• The investigation is not intended to be reported to FDA as a well-controlled study in
support of a new indication and there is no intent to use it to support any other significant
change in the labeling of the drug.
• In the case of a prescription drug, the investigation is not intended to support a significant
change in the advertising for the drug.
• The investigation does not involve a route of administration, dose, patient population, or
other factor that significantly increases the risk (or decreases the acceptability of the risk)
associated with the use of the drug product (21 CFR 312.2(b)(1)(iii)).
• The investigation is conducted in compliance with the requirements for review by an IRB
(21 CFR part 56) and with the requirements for informed consent (21 CFR part 50).
• The investigation is conducted in compliance with the requirements of § 312.7 (i.e., the
investigation is not intended to promote or commercialize the drug product).De toelichting bij het eerste bolletje meldt onder andere:
The exemption was not intended to require an investigator to use the drug in
exactly the same dosage form, dosage levels, and patient populations described in
the marketed labeling for the product, but rather to permit changes to the lawfully
marketed drug product that do not increase the risks . . . over the risk presented by
use of the product in conformance with its marketed labeling.De vraag die bij mij dan wel opkomt, is over wat ik hierboven heb onderstreept: hoe verhoudt zich dat met het bestempelen van genoemde PID-aandoeningen als nieuwe indicatie? Mogelijk is mijn interpretatie van 'onder bestaande NDA' dus onjuist.