CDSCO panel rejects Novartis Phase III CT protocol for Lanalumab Rahul Verma30 July 2022 6:33 PM ISTCiting that the clinical trial protocol missed some inclusion/exclusion criteria, the Subject Expert Committee (SEC) functional under Central Drug...
CDSCO issues alert on Baxter Blood Purification Device Hemoperfusion Cartridge Dr. Divya Colin30 July 2022 6:00 PM ISTNew Delhi: In suspecting the presence of particulate matter, Central Drug Standard Control Organization (CDSCO) has issued medical devices alert on...
Novartis Phase III CT protocol for Lanalumab Rejected by CDSCO Panel Dr. Divya Colin29 July 2022 6:00 PM ISTNew Delhi: Citing that the clinical trial protocol missed some inclusion/exclusion criteria, the Subject Expert Committee (SEC) functional under...
Biophore India Pharma arm gets CDSCO nod to manufacture, sell generic version of Pfizer COVID drug Paxlovid Ruchika Sharma28 July 2022 12:32 PM ISTIt was the first oral pill that has been approved by USFDA and with a better safety profile than subsequently approved oral therapies.
CDSCO Panel nod to AstraZeneca Olaparib for BRCA Mutated HER2 Negative Breast Cancer Rahul Verma26 July 2022 5:48 PM ISTBased on the scientific data provided by the drug maker AstraZeneca, the Subject Expert Committee (SEC) functional under Central Drug Standard Control...
No relief to Medical Device makers: Health Minister declines to relax deadline for registration of medical devices Rahul Verma26 July 2022 5:30 PM ISTMajority of the medical devices in India will come under the licensing regime from October 1 as notified by the central government, with Union Health...
Intas Pharma bags CDSCO panel nod to study Human Normal Immunoglobulin Rahul Verma26 July 2022 5:30 PM ISTPharmaceutical major Intas Pharma has got the go-head from the Subject Expert Committee (SEC) functional under Central Drug Standard Control...
No relief to medical device makers: Health Minister declines to relax last date for registration of medical devices Ruchika Sharma26 July 2022 1:20 PM ISTAs per the rules, unregistered devices will not be deemed authorised and manufacturers may face penal action, an official source said.
Intas Pharma Gets CDSCO Panel Okay To Study Human Normal Immunoglobulin Dr. Divya Colin25 July 2022 6:00 PM ISTNew Delhi: Pharmaceutical major Intas Pharma has got the go-head from the Subject Expert Committee (SEC) functional under Central Drug Standard...
CDSCO panel nod to Novartis Ruxolitinib for acute and chronic graft versus host disease Rahul Verma24 July 2022 2:15 PM ISTIn response to the pharma major Novartis proposal for additional indication of Ruxolitinib Tablets 5/10/15/20 mg, the Subject Expert Committee (SEC)...
Class A, Class B non notified medical devices must enter licencing regime effective on October 10, 2022 Dr. Divya Colin24 July 2022 12:52 PM ISTNew Delhi: Referring the previous notification No. G.S.R. 102(E) dated 11.02.2020, the Government of India, the Director-General of Health Services,...
Novartis Ruxolitinib Gets CDSCO Panel Okay for Acute and Chronic Graft Versus Host Disease Dr. Divya Colin22 July 2022 6:00 PM ISTNew Delhi: In response to the pharma major Novartis proposal for additional indication of Ruxolitinib Tablets 5/10/15/20 mg, the Subject Expert...
