CDSCO Panel Rejects Pfizer's Proposal to Waive Phase IV CT of Antimicrobial FDC Dr. Divya Colin13 March 2023 6:00 PM ISTNew Delhi: Highlighting that there is no unmet need for a Phase IV clinical trial study waiver, the Subject Expert Committee (SEC) functional under...
Centre should regulate manufacturing of drugs instead of state bodies, new bill moots Ruchika Sharma13 March 2023 12:05 PM ISTThe proposed bill provides for regulation of clinical trials of new drugs, investigational new drugs, the ethics committee etc.
Synokem gets CDSCO panel nod to study Dyhydogestrone as part of Assisted Reproductive Technology Dr. Divya Colin12 March 2023 6:00 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to drug...
Boehringer Ingelheim gets CDSCO panel nod to market Spesolimab indicated for generalized pustular psoriasis Dr. Divya Colin11 March 2023 6:00 PM ISTNew Delhi: Granting the local clinical trial waiver, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Akums gets CDSCO panel nod to manufacture, market FDC Alfuzosin HCL,Tadalafil film coated tablets Dr. Divya Colin10 March 2023 6:00 PM ISTNew Delhi: Drug major Akum Pharmaceuticals has received a green signal from the Subject Expert Committee (SEC) functional under the Central Drug...
Present More Data on drug abuse potential of Tapentadol: CDSCO tells Wockhardt for FDC Dicyclomine,Tapentadol Dr. Divya Colin8 March 2023 5:15 PM ISTNew Delhi: Regarding the fixed dose combination (FDC) drug Dicyclomine plus Tapentadol, the Subject Expert Committee (SEC) functional under the...
Lupin gets CDSCO panel nod to study Ranibizumab Dr. Divya Colin7 March 2023 6:00 PM ISTNew Delhi: The drug major Lupin has got the green signal from the Subject Expert Committee (SEC) from the Central Drug Standard Control Organisation...
Roche gets CDSCO Panel nod to import, market ophthalmic drug Faricimab solution Dr. Divya Colin6 March 2023 6:00 PM ISTNew Delhi: Granting the request for waiver of Phase III clinical trial of Faricimab 6mg/0.05mL solution for Intravitreal Injection in the country, the...
Present revised Phase III CT protocol : CDSCO Tells Hetero Lab on Antidiabetic FDC Drug Dr. Divya Colin6 March 2023 6:00 PM ISTNew Delhi: Granting permission to conduct the bioequivalence (BE) study for antidiabetic fixed dose combination (FDC) of Sitagliptin phosphate...
Revise Phase II/III CT protocol of Yellow Fever Vaccine Live: CDSCO Panel Tells Serum Institute of India Dr. Divya Colin4 March 2023 6:00 PM ISTNew Delhi: Reviewing the proposal presented by the vaccine maker Serum Institute of India to conduct Phase II/III clinical trial of Yellow Fever...
3 employees of Noida-based Marion Biotech arrested Ruchika Sharma4 March 2023 12:30 PM ISTNew Delhi: The Noida Police on Friday arrested three employees of a Noida-based pharmaceutical firm whose cough syrup is alleged to have led to the...
Dr Reddy's gets CDSCO panel nod to study Darbepoetin alfa Dr. Divya Colin1 March 2023 6:00 PM ISTNew Delhi: The drug major Dr Reddy's Laboratories has got a green signal from the Subject Expert Committee (SEC) functional under the Central Drug...
