Expansion of warning statement may be considered after submission of first year PSUR data: CDSCO panel on AstraZeneca's anticancer drug Dr. Divya Colin25 Jun 2024 10:28 PM ISTNew Delhi: Noting that Tremelimumab Concentrate for Solution for infusion 20 mg/ml is not yet launched in the Indian market, the Subject Expert...
Sun Pharma Industries Gets CDSCO Panel Nod to assess safety and efficacy of Relugolix Tablets for advanced prostate cancer Dr. Divya Colin24 Jun 2024 6:00 PM ISTNew Delhi: In order to assess the safety and efficacy of Relugolix Tablets 120 mg indicated for the treatment of advanced prostate cancer, the Subject...
NPPA authority rejects Sun Pharmaceuticals application for separate ceiling price for Antibiotic Suspension Dual Chamber Pack with novel technology Dr. Divya Colin23 Jun 2024 6:00 PM ISTNew Delhi: Observing that there is no data or evidence in the survey report that shows reduction in reconstitution time and spillage as claimed, the...
Submit safety data of Rotavirus vaccine in 1 to 2 years age group: CDSCO panel Tells Bharat Biotech on Oral Rotavirus Vaccine Dr. Divya Colin22 Jun 2024 6:00 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined the vaccine major...
Zydus Life Science Gets CDSCO Panel Nod To Manufacture and Market Anti-cancer Drug Nelarabine Dr. Divya Colin21 Jun 2024 6:00 PM ISTNew Delhi: In a significant development, the drug major Zydus Life Science has got approval from the Subject Expert Committee (SEC) functional under...
Drug Safety Alert: Indian Pharmacopoeia Commission Flags ADR Linked To Meropenem Dr. Divya Colin20 Jun 2024 6:00 PM ISTNew Delhi: The Indian Pharmacopoeia Commission (IPC), through its recently issued drug safety alert for the month of May, has revealed that the...
NPPA directs Macleods Pharmaceuticals to supply antituberculosis drug Rifampicin capsules to CMSS Dr. Divya Colin19 Jun 2024 10:57 PM ISTNew Delhi:In a significant move to ensure adequate availability, invoking para 3 of the Drugs (Prices Control) Order, 2013, the National...
CDSCO Panel Rejects Roche Products India local Phase III CT waiver proposal for Atezolizumab injection SC route Dr. Divya Colin18 Jun 2024 6:00 PM ISTNew Delhi: Recommending to conduct a phase III study in the Indian population to establish the safety and efficacy, the Subject Expert Committee (SEC)...
CDSCO declares 5 formulations as spurious: Details Dr. Divya Colin17 Jun 2024 6:00 PM ISTNew Delhi: In the latest spurious drug alert, the apex drug regulatory body, the Central Drug Standard Control Organization (CDSCO), has declared 5...
Demonstrate safety and adequacy of dose: CDSCO Panel Tells Intas Pharmaceuticals on Bevacizumab injection Dr. Divya Colin16 Jun 2024 6:00 PM ISTNew Delhi: Reviewing the justification presented by the drug major Intas Pharmaceuticals for not conducting the initial phase of clinical studies of...
CDSCO Panel advises Dr Reddy's Laboratories to Revise Phase III CT Protocol for Live Attenuated Varicella Vaccine study Dr. Divya Colin15 Jun 2024 6:00 PM ISTNew Delhi: Reviewing the Phase III clinical trial protocol presented by the drug major, Dr Reddy's Laboratories, the Subject Expert Committee (SEC)...
Include nebulization methodology, nebulizer types: CDSCO Panel Tells Glenmark pharmaceuticals on Pulmonary FDC Dr. Divya Colin14 Jun 2024 6:00 PM ISTNew Delhi: Citing to include nebulization methodology, type of nebulizer, and interface, the Subject Expert Committee (SEC) functional under the...
