Experts Advocate Easing NDA Clinical Trial Requirements For Nicotine Replacement Therapies
This article was originally published in The Pink Sheet Daily
Experts recommend relaxing the clinical studies requirement for NDAs submitted for NRTs, saying many proposed new products would be bioequivalent to or have the same ingredients as products already on the market.
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While the agency appears to favor moving to a broad harm reduction framework for indications for NRTs, including lifting limits on recommended duration of use, there remains “a lot of devil in the details” of expanding indications.
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The “Contract Manufacturing Arrangements for Drugs: Quality Agreements” draft guidance describes how parties involved in contract manufacturing of drugs can employ quality agreements to delineate their responsibilities and ensure drug quality, safety and efficacy.