Drug Alert: CDSCO Flags 57 Formulations As Not Of Standard Quality Dr. Divya Colin29 Aug 2024 6:00 PM ISTNew Delhi: In its latest drug safety alert, the apex drug regulatory body, the Central Drugs Standard Control Organization (CDSCO), has flagged 57...
Exemed Pharmaceutical Gets CDSCO Panel Nod To Manufacture, Market Empagliflozin plus Sitagliptin FDC Dr. Divya Colin28 Aug 2024 6:15 PM ISTNew Delhi: Exemed Pharmaceutical has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Submit PMS data in Indian Population: CDSCO Panel Tells Sanofi Healthcare on updation prescribing information of Adacel vaccine Dr. Divya Colin27 Aug 2024 6:00 PM ISTNew Delhi: Responding to the proposal presented by Sanofi Healthcare India for updating prescribing information for Tetanus Toxoid, Reduced Diphtheria...
CDSCO Panel grants AstraZeneca Pharma's proposal to include self-administration in package insert of Benralizumab Dr. Divya Colin26 Aug 2024 6:00 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved drug major...
Dr Reddy's Laboratories gets CDSCO Panel nod to study Live Attenuated Varicella Vaccine Dr. Divya Colin25 Aug 2024 6:00 PM ISTNew Delhi: Dr. Reddy's Laboratories has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Submit details of adverse events reported: CDSCO Panel Tells GSK on Mepolizumab Powder for Solution for Injection Dr. Divya Colin24 Aug 2024 6:00 PM ISTNew Delhi: In line with the Phase IV clinical trial report of the monoclonal antibody Mepolizumab (Brand Name: Nucala 100 mg) presented by the drug...
NPPA Revises Ceiling Price of 4 Scheduled Formulation, Detail Dr. Divya Colin23 Aug 2024 6:00 PM ISTNew Delhi: Through a recent notice, after considering the Wholesale Price Index (WPI) impact at 0.00551% for the year 2024, the National...
156 FDCs banned with immediate effect, declared irrational: Ministry of Health and Family Welfare Ruchika Sharma22 Aug 2024 6:00 PM ISTNew Delhi: Citing that there is no therapeutic justification for the ingredients contained in fixed dose combinations (FDC) and that the FDC may...
Shri Arunish Chawla assigned to additional role of Chairman, National Pharmaceuticals Pricing Authority Dr. Divya Colin21 Aug 2024 6:00 PM ISTNew Delhi: In a recent notice, the Department of Pharmaceuticals, the Ministry of Chemicals and Fertiliser, the National Pharmaceutical Pricing...
NPPA Fixes Retail Prices of 70 Formulations, Details Dr. Divya Colin20 Aug 2024 6:00 PM ISTNew Delhi: Through a recent notice, the National Pharmaceutical Pricing Authority (NPPA), the Ministry of Chemicals and Fertilizers, the Government of...
Submit diagnosis criteria for lower respiratory infection and earlier study data: CDSCO Panel Tells Pfizer on Sisunatovir capsule Dr. Divya Colin19 Aug 2024 6:00 PM ISTNew Delhi: Reviewing the Phase 1b clinical study protocol for Sisunatovir 50 mg capsules, the Subject Expert Committee (SEC) functional under the...
Increase sample size for immunogenicity analysis for booster dose: CDSCO Panel Tells Biological E on PCV-14 Vaccine Dr. Divya Colin18 Aug 2024 6:00 PM ISTNew Delhi: Reviewing the amended Phase IV clinical trial protocol of Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) (14-valent) [PCV-14]...
