GSK Gets CDSCO Panel Nod to study safety of anti-cancer drug Dostarlimab Dr. Divya Colin23 Dec 2023 6:00 PM ISTNew Delhi: Citing that the total number of evaluable patients in the study should be a minimum of 30, the Subject Expert Committee (SEC) functional...
Modify Phase IV CT protocol: CDSCO Panel Tells Alkem on Amoxicillin, Clavulanate Oral Suspension Dr. Divya Colin20 Dec 2023 6:56 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Alkem...
Revise Phase IV clinical trial protocol of Nimesulide Granules for oral suspension: CDSCO Panel Tells Dr Reddys Dr. Divya Colin18 Jun 2023 11:00 AM ISTNew Delhi: The Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has recommended the drug major Dr....
J&J Gets CDSCO Panel Nod To Conduct Phase IV CT of Ustekinumab Dr. Divya Colin16 April 2023 5:45 PM ISTNew Delhi: In order to evaluate safety of Ustekinumab in Indian subjects with Crohn’s Disease (CD), pharmaceutical major, Johnson & Johnson has...
CDSCO Panel Rejects Pfizer's Proposal to Waive Phase IV CT of Antimicrobial FDC Dr. Divya Colin13 March 2023 6:00 PM ISTNew Delhi: Highlighting that there is no unmet need for a Phase IV clinical trial study waiver, the Subject Expert Committee (SEC) functional under...
CDSCO panel seeks data for Eli Lilly's anticancer drug selpercatinib Dr. Divya Colin21 Feb 2023 6:00 PM ISTNew Delhi: In response to the drug major Eli Lilly's proposal to waive off Phase IV clinical trial in the country for the Selpercatinib 40 & 80mg...
CDSCO Panel grants Cadila Healthcare's protocol amendment for Saroglitazar Tablets Dr. Divya Colin5 Feb 2023 5:30 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major ....
Glenmark Gets CDSCO panel nod for Phase IV CT of Fosnetupitant, Palanosetron FDC drug Dr. Divya Colin5 Feb 2023 5:00 PM ISTNew Delhi: Pharmaceutical major Glenmark Pharmaceutical has got approval from the Subject Expert Committee (SEC) functional under Central Drug...
CDSCO Panel allows Cipla to waive requirements for phase 4 study of tocilizumab inj for giant cell arthritis Dr. Divya Colin19 Jan 2023 6:00 PM ISTNew Delhi: Considering that Giant Cell Arthritis is very rare disease and there is challenge in recruitment of patients, the Subject Export Committee...
Zydus Gets CDSCO Panel Nod To Study Follitropin alfa Dr. Divya Colin8 Dec 2022 6:00 PM ISTNew Delhi: The drug major Zydus has got a green signal from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
CDSCO panel approves GSK pharma's protocol amendment proposal for Mepolizumab Powder for Solution for Injection Dr. Divya Colin20 Nov 2022 3:15 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has approved the drug major GSK...
Eli Lilly Gets CDSCO Nod To Study Anti-diabetic Dulaglutide Dr. Divya Colin12 Nov 2022 6:00 PM ISTNew Delhi: Pharmaceutical major, Eli Lilly has got the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization...
