Conduct trial with additional safety arm of 1800 subjects: CDSCO Panel Tells Bharath Biotech on Cholera Vaccine Dr. Divya Colin10 Jan 2023 6:00 PM ISTNew Delhi: Regarding the already approved Phase III clinical trial protocol of Cholera Vaccine (Inactivated Vibrio cholarae, MS 1568, Oral), the...
Submit Clinical Comparative Data: CDSCO panel tells Abbott Healthcare On Metronidazole ER Tablet Dr. Divya Colin8 Jan 2023 6:00 PM ISTNew Delhi: Citing that the drug major Abbott Healthcare did not present any comparative clinical data of proposed drug product, the Subject Expert...
CDSCO issues medical device alert for Abbott MitraClip Device Roshni Dhar7 Jan 2023 5:42 PM ISTSuspecting the risk of potential clip lock malfunctions with MitraClip Clip Delivery Systems manufactured by Abbott, the Central Drugs Standard...
Health Bulletin 7/January/2022 Roshni Dhar7 Jan 2023 4:43 PM ISTHere are the top health stories for the day:CDSCO issues medical device alert for Abbott MitraClip DeviceSuspecting the risk of potential clip lock...
CDSCO issues Medical Device Alert for Abbott MitraClip Device Susmita Roy6 Jan 2023 6:00 PM ISTNew Delhi: Suspecting the risk of potential clip lock malfunctions with MitraClip Clip Delivery Systems manufactured by Abbott, the Central Drugs...
CDSCO orders inspection of pharmacovigilance system of importers, manufacturers of human vaccines Farhat Nasim5 Jan 2023 6:00 PM ISTNew Delhi: The Central Drugs Standard Control Organization (CDSCO) has recently ordered inspections/audits of pharmacovigilance system of importers...
MSN Labs Gets CDSCO Panel Nod To Manufacture, Market Fesoterodine Fumarate ER tablets Dr. Divya Colin4 Jan 2023 6:00 PM ISTNew Delhi: In response to the Phase III clinical trial report of Fesoterodine Fumarate extended release tablets 4 mg and 8 mg, the Subject Expert...
Molbio Diagnostics unveils Herpes Simplex Virus test 'Truenat HSV-1/2' Ruchika Sharma4 Jan 2023 2:59 PM ISTNew Delhi: Molbio Diagnostics has launched the Truenat HSV 1/2 for testing the Herpes Simplex Virus. The test is approved by CDSCO and can...
Amend revised Phase IV CT protocol: CDSCO panel tells GSK on Respiratory Drug Combination Dr. Divya Colin3 Jan 2023 5:45 PM ISTNew Delhi: In response to the GSK's revised Phase IV clinical trial protocol for the pulmonary fixed dose combination (FDC) drug, Fluticasone...
Ajanta Pharma gets CDSCO Panel nod to study Tadalafil Oral Jelly for erectile dysfunction Dr. Divya Colin3 Jan 2023 5:30 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has granted approval to the drug...
Sun Pharma's proposal to amend CT protocol for pimavanserin gets CDSCO Panel nod Dr. Divya Colin2 Jan 2023 6:00 PM ISTNew Delhi: Approving Sun Pharma's proposal to amend the existing clinical trial protocol for the atypical antipsychotic Pimavanserin Capsules, the...
Submit Phase IV CT protocol for Entrectinib: CDSCO panel tells Roche India Dr. Divya Colin2 Jan 2023 5:45 PM ISTNew Delhi: Rejecting the drug major Roche's alternative proposal to the Phase IV clinical trial of anti-cancer Entrectinib capsules of 100 mg and 200...
