Zydus Told to Withdraw Unmarketed Strengths, Conduct Phase IV Trial for Approved Combinations Only Dr. Divya Colin23 May 2025 9:44 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has directed Zydus Healthcare Ltd. to...
CDSCO Panel Demands Structured Phase IV Protocol for Ademetionine in Liver Disease Subtypes Dr. Divya Colin15 May 2025 6:00 PM ISTNew Delhi: After reviewing the Phase IV clinical trial report of Ademetionine Tablets, the Subject Expert Committee (SEC) functioning under the...
Glenmark gets CDSCO Panel nod to study Glycopyrronium, Fluticasone Furoate, Vilanterol Powder for Inhalation Dr. Divya Colin10 April 2025 5:45 PM ISTNew Delhi: In line with the revised Phase IV clinical trial protocol of Glycopyrronium 50 mcg plus Fluticasone Furoate 100 mcg plus Vilanterol 25 mcg...
Synokem Pharmaceutical Gets CDSCO Panel Nod To study Tofacitinib Extended Release Tablets Dr. Divya Colin19 March 2025 6:00 PM ISTNew Delhi: Synokem Pharmaceutical has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Synokem Pharmaceutical Gets CDSCO Panel Nod To Study Anti-rheumatoid drug Iguratimod Dr. Divya Colin14 March 2025 4:00 PM ISTNew Delhi: Suggesting to specify the eGFR (Modification of Diet in Renal Disease Formula) or chronic kidney disease (CKD) stage in the exclusion...
Sun Pharmaceutical Industries Gets CDSCO Panel Nod to Study Ranibizumab Solution for Injection Dr. Divya Colin9 Nov 2024 5:30 PM ISTNew Delhi: The drug major Sun Pharmaceutical Industries has got approval from the Subject Expert Committee (SEC) functional under the Central Drug...
Serum Institute of India gets CDSCO Panel nod to study Measles, Mumps, and Rubella Vaccine Live Freeze-Dried Dr. Divya Colin13 Oct 2024 6:00 PM ISTNew Delhi: Vaccine major Serum Institute of India has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug...
Incorporate sample size proportionate with each indication: CDSCO Panel Tells Sun Pharma on Ranibizumab study Dr. Divya Colin3 Jun 2024 6:00 PM ISTNew Delhi: Reviewing the proposal for conducting the Phase IV study of Ranibizumab Solution for Injection 10 mg/mL, the Subject Expert Committee (SEC)...
CDSCO panel agrees with Sun Pharmaceutical's Phase IV Trial Results of Cephalexin plus Clavulanate Potassium Tablets Dr. Divya Colin16 May 2024 6:00 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has agreed to the Phase IV...
Lupin Gets CDSCO Panel Nod to Study Glycopyrronium Bromide, Vilanterol Trifenatate powder for inhalation in capsule Dr. Divya Colin13 April 2024 5:30 PM ISTNew Delhi: Reviewing the Phase IV clinical trial protocol of Lupin's pulmonary FDC (Fixed Dose Combination) Glycopyrronium Bromide plus Vilanterol...
Abbott gets CDSCO Panel Nod To study FDC Dydrogesterone plus Estradiol Dr. Divya Colin14 March 2024 6:00 PM ISTNew Delhi: The drug major Abbott has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Lupin Gets CDSCO Panel Nod to Study FDC of Fluticasone, Glycopyrronium, Vilanterol Inhalation Powder Dr. Divya Colin23 Jan 2024 6:00 PM ISTNew Delhi: The drug major Lupin has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
