DTAB Approves Notification System for Application of new drug, IND for clinical trial, BA-BE study Dr. Divya Colin11 May 2025 5:45 PM ISTNew Delhi: With an aim to streamline the process for permission to manufacture new drugs and investigational new drugs (IND) for clinical trials,...
Submit justification for dose assumption and animal toxicity data: CDSCO Panel Tells Lupin on Rizatriptan nasal spray Dr. Divya Colin29 Dec 2024 6:00 PM ISTNew Delhi: Regarding the proposed bioavailability study protocol for Rizatriptan nasal spray (2.5 mg/spray, 5 mg/spray, 7.5 mg/spray), the Subject...
CT waiver not considered, Conduct BA study: CDSCO Panel Tells Sun Pharma on Pulmonary FDC Dr. Divya Colin30 March 2024 6:00 PM ISTNew Delhi: Denying to consider the clinical trial waiver proposal for the fixed dose combination (FDC) Vilanterol Trifenatate plus Umeclidinium...
Hetero Labs, Optimus proposal to launch generic Paxlovid rejected by CDSCO panel: Report Dr. Divya Colin27 Jan 2022 6:10 PM ISTNew Delhi: In a major setback to Hetero Labs and Optimus Pharma, Subject Expert Committee (SEC) functional under the Central Drugs Standard Control...
Govt amends NDCT Rules 2019 to clarify definition of bioavailability, bioequivalence study centre Medical Dialogues Team7 Sept 2021 4:08 PM ISTNew Delhi: Amending the New Drugs and Clinical Trials Rules, 2019, through a recent gazette notification, the Ministry of Health and Family Welfare...
