CDSCO Committee Asks Elevate Scientific To Prove Back Pain Gel In Indian Trial
New Delhi: With an aim to demonstrate the safety and efficacy on lower back pain, the Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organisation (CDSCO) has opined that Elevate Scientific should conduct the clinical investigation of Radiopaque Gelified Ethanol (Absolute Gel) on the Indian population.
In addition, the expert panel suggested that the firm needs to submit the Clinical Investigation Protocol with a statistically significant sample size for taking further necessary action in the matter.
This came as Elevate Scientific presented clinical study data generated globally (Iran, Italy, etc.) along with post-marketing data on Radiopaque Gelified Ethanol (Absolute Gel) for the waiver of one of the conditions of the permission for manufacturing obtained under Form MD27 and proposed to allow them to market the product for domestic use.
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