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Tag: sec committee

You Searched For "sec committee"
Novartis proposal to market Inclisiran with clinical trial waiver rejected by CDSCO panel

Novartis proposal to market Inclisiran with clinical trial waiver rejected by CDSCO panel

Medical Dialogues Team24 Oct 2021 11:30 AM IST
New Delhi: Rejecting Novartis Healthcare's proposal to import and market Inclisiran Solution for Injection with a local clinical trial waiver,...
Sun Pharma

Sun Pharma told to submit revised CT protocol for Ferric Pyrophosphate Citrate Solution

Medical Dialogues Team22 Oct 2021 6:24 PM IST
New Delhi: In response to the drug-major Sun Pharma Ltd's phase 3 protocol of Ferric Pyrophosphate Citrate Solution, the Subject Expert Committee...
rpg life azoran

CDSCO panel rejects IQVIA proposed study of Proxalutamide in COVID patients

Medical Dialogues Team12 Oct 2021 6:22 PM IST
New Delhi: Rejecting IQVIA's proposed study, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has denied...
Use only ICMR approved kits for rapid serological test: CDSCO panel tells JnJ on Ad26.COV2.S study

Use only ICMR approved kits for rapid serological test: CDSCO panel tells JnJ on Ad26.COV2.S study

Medical Dialogues Team10 Oct 2021 11:30 AM IST
New Delhi: Reiterating the prior suggestion, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has opined...
Glenmark gets CDSCO panel nod to study antidiabetic drug Lobeglitazone Sulfate

Glenmark gets CDSCO panel nod to study antidiabetic drug Lobeglitazone Sulfate

Medical Dialogues Team6 Oct 2021 6:26 PM IST
New Delhi: In a significant development, drug firm Glenmark has got a green signal from the Subject Expert Committee (SEC) functional under the...
Sanofi gets CDSCO panel marketing authorization for Insulin Glargine

Sanofi gets CDSCO panel marketing authorization for Insulin Glargine

Medical Dialogues Team3 Oct 2021 11:30 AM IST
New Delhi: Approving the waiver of additional requirements for local clinical trials in the country, the Subject Expert Committee (SEC) functional...
Clarify, revise protocol for phase 3 trial of Dengue Tetravalent Vaccine: CDSCO panel tells Panacea Biotec

Clarify, revise protocol for phase 3 trial of Dengue Tetravalent Vaccine: CDSCO panel tells Panacea Biotec

Medical Dialogues Team2 Oct 2021 11:30 AM IST
New Delhi: In response to Panacea Biotec's proposal to conduct a phase 3 clinical trial of its Dengue Tetravalent Vaccine, the Subject Expert...
Mylan gets CDSCO panel nod to import, market Cutaneous Cryogenic Spray of Endwarts Freeze

Mylan gets CDSCO panel nod to import, market Cutaneous Cryogenic Spray of Endwarts Freeze

Medical Dialogues Team26 Sept 2021 11:00 AM IST
New Delhi: Mylan Pharmaceuticals has received approval from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization...
Intas secures CDSCO panel nod to study arthritis drug Adalimumab

Intas secures CDSCO panel nod to study arthritis drug Adalimumab

Medical Dialogues Team24 Sept 2021 5:08 PM IST
New Delhi: In a significant development, drug firm Intas has got a green signal from the Subject Expert Committee (SEC) functional under the Central...
Roche antibody cocktail for post-exposure prophylaxis of Covid-19 for adults gets CDSCO panel okay

Roche antibody cocktail for post-exposure prophylaxis of Covid-19 for adults gets CDSCO panel okay

Medical Dialogues Team21 Sept 2021 5:05 PM IST
New Delhi: With the aim of reducing the spread of the Covid-19 epidemic, the Subject Expert Committee (SEC), functional under the Central Drug...
Hetero gets CDSCO panel nod to manufacture Sputnik V for restricted emergency use

Hetero gets CDSCO panel nod to manufacture Sputnik V for restricted emergency use

Medical Dialogues Team21 Sept 2021 4:20 PM IST
New Delhi: In a significant development, drug firm Hetero has got the green signal from the Subject Expert Committee (SEC) functional under the...
Sanofi plea for Insulin Glargine, Lixisenatide antidiabetic combination rejected by CDSCO panel

Sanofi plea for Insulin Glargine, Lixisenatide antidiabetic combination rejected by CDSCO panel

Medical Dialogues Team16 Sept 2021 4:14 PM IST
New Delhi: In a major setback to Sanofi India Limited, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO)...
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