Revise BE study Protocol: CDSCO Panel Tells Akum Pharma on Chlorthalidone, Cilnidipine, Bisoprolol FDC Dr. Divya Colin24 Dec 2023 6:00 PM ISTNew Delhi: Citing that individual and innovators products should be taken as a reference product in the proposed bioequivalence (BE) study protocol,...
Justify dose and rationality: CDSCO Panel Tells Alkem Laboratories on FDC Sacubitril plus Valsartan Dr. Divya Colin24 Dec 2023 5:30 PM ISTNew Delhi: In response to the proposal for bioequivalence (BE) study and Phase III clinical trial (CT) waiver for Sacubitril 12mg plus Valsartan 13mg...
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...
Novartis Gets CDSCO Panel Nod to study Iptacopan Dr. Divya Colin23 Dec 2023 6:00 PM ISTNew Delhi: In response to the proposal presented by the drug major Novartis, the Subject Expert Committee (SEC) functional under the Central Drug...
J&J Gets CDSCO Panel Nod to study anti-cancer drug Talquetamab Dr. Divya Colin22 Dec 2023 6:00 PM ISTNew Delhi: The drug major Johnson and Johnson has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard...
Conduct bioequivalence study: CDSCO Panel tells Zydus Healthcare on Glycopyrrolate, Indacaterol Metered dose inhalation Dr. Divya Colin22 Dec 2023 6:00 PM ISTNew Delhi: Rejecting the clinical trial waiver proposal, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Exemed Pharma Gets CDSCO Panel Nod To Manufacture, Market Antidiabetic FDC Drug Dr. Divya Colin22 Dec 2023 5:00 PM ISTNew Delhi: The drug major Exemed Pharmaceutical has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard...
Synokem Pharmaceutical Gets CDSCO Panel Nod To study Antidiabetic FDC Drug Dr. Divya Colin21 Dec 2023 6:00 PM ISTNew Delhi: With the condition of including more government sites distributed geographically, Synokem Pharmaceutical has got approval from the Subject...
CDSCO bans anti-cold drug combination for kids aged under four Roshni Dhar21 Dec 2023 5:27 PM ISTTo ensure the safety of infants and young children in the country, the Central Drugs Standard Control Organization (CDSCO) has recently banned the use...
Health Bulletin 21/December/2023 Roshni Dhar21 Dec 2023 5:06 PM ISTHere are the top health stories for the day:Short-circuit causes fire in high profile SGPGI, two deadTwo patients, including a child and a woman, died...
CDSCO bans use of Chlorpheniramine Maleate IP 2mg and Phenylephrine HCL IP 5mg drop/ml FDC in kids below 4 years Ruchika Sharma21 Dec 2023 2:19 PM ISTNew Delhi: To ensure the safety of infants and young children in the country, the Central Drugs Standard Control Organization (CDSCO) has...
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...
