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  • in Health care

    Submit complete safety data: CDSCO panel tells Novartis on Remibrutinib

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    New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has recommended the drug maker Novartis to submit complete safety data of the ongoing study of Bruton’s tyrosine kinase inhibitor Remibrutinib till date for further review by the committee to allow an extension of the current study. Bruton’s tyrosine […] More

  • in Health care

    Glenmark Gets CDSCO panel nod for Phase IV CT of COPD drug

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    New Delhi: Pharmaceutical major, Glenmark has got the green signal from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase IV clinical trial of the fixed dose combination (FDC) Glycopyrrolate plus Budesonide plus Formoterol Fumarate dihydrate actuation delivers inhalation aerosol. However, this approval is subjected to […] More

  • in Health care

    Akums gets CDSCO Panel nod for Phase III CT of FDC Moxifloxacin, Nepafenac ophthalmic solution

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    New Delhi: The drug major Akum Pharmaceutical has got the green signal from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct the Phase III clinical trial study of the fixed-dose combination of Moxifloxacin plus Nepafenac ophthalmic solution. This came after the firm presented the revised Phase III […] More

  • in Health care

    Revise Phase I/II CT protocol: CDSCO panel tells Serum Institute of India on Dengue Tetravalent Vaccine

    Revise Phase I/II CT protocol: CDSCO panel tells Serum Institute of India on Dengue Tetravalent Vaccine

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    New Delhi: Regarding the Phase I/II clinical trial of Dengue Tetravalent Vaccine (Live, Attenuated), the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has opined the vaccine major Serum Institute of India to revise the Phase I/II clinical trial protocol. This came after the firm presented its proposal to conduct of […] More

  • in Health care

    J&J Gets CDSCO Panel Nod To Conduct Phase IV CT of Ustekinumab

    J&J Gets CDSCO Panel Nod To Conduct Phase IV CT of Ustekinumab

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    New Delhi: In order to evaluate safety of Ustekinumab in Indian subjects with Crohn’s Disease (CD), pharmaceutical major, Johnson & Johnson has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase IV trial of Ustekinumab Pre-filled syringes 45 mg/0.5 ml, 90 mg/ml […] More

  • in Health care

    Present More Data On Almitrine, Ifenprodil: CDSCO Panel Tells CDRI-CSIR

    Present More Data On Almitrine, Ifenprodil: CDSCO Panel Tells CDRI-CSIR

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    New Delhi: After deliberating the Phase III clinical trial protocol of the pulmonary drug Almitrine and Ifenprodil, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the Central Drug Research Institute- Council of Scientific & Industrial Research (CDRI-CSIR) to submit preclinical data, proof of the concept for the […] More

  • in Health care

    Revise Phase III CT protocol: CDSCO Panel Tells Dr Reddy’s over Tegoprazan

    Revise Phase III CT protocol: CDSCO Panel Tells Dr Reddy's over Tegoprazan

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    New Delhi: In response to the proposal to conduct a Phase III clinical trial presented by the drug major Reddy’s Laboratories, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has opined the firm to revise the protocol of Phase III clinical trial of the drug Tegoprazan with respect to the […] More

  • in Health care

    Revise Phase IV CT Protocol: CDSCO panel tells Zydus Lifesciences on Typhoid Vi Conjugate Vaccine with Yellow Fever Vaccine

    Revise Phase IV CT Protocol: CDSCO panel tells Zydus Lifesciences on Typhoid Vi Conjugate Vaccine with Yellow Fever Vaccine

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    New Delhi: In response to the drug major Zydus Life Sciences’ proposal to conduct Phase IV clinical for Typhoid Vi Conjugate Vaccine I.P.(TCV) with Yellow Fever Vaccine(YFV), the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has opined the firm to revise the Phase IV clinical trial protocol. This came after […] More

  • in Health care

    CDSCO Panel Grants Abbott’s Protocol Amendment Proposal For Ursodeoxycholic Acid

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    CDSCO Panel Grants Abbott's Protocol Amendment Proposal For Ursodeoxycholic Acid

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    New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has accepted Abbott’s phase III clinical trial protocol amendment proposal for Ursodeoxycholic Acid Tablets IP 150 mg, 300 mg, 450 mg, and 600 mg with respect to inclusion and exclusion criteria. Ursodeoxycholic acid, or ursodiol, is a naturally occurring […] More

  • in Health care

    CDSCO seeks details of 16 FDCs named as irrational for further examination

    CDSCO seeks details of 16 FDCs named as irrational for further examination

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    New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has issued a notice seeking all the manufacturers of the 16 Fixed Dose Combinations (FDCs) which were earlier considered as irrational in an expert panel report to submit the information in a prescribed format for further evaluation. This comes in connection with the decision of the […] More

  • in Health care

    Lupin Gets CDSCO Panel Nod for Phase IV CT of pulmonary FDC drug

    Lupin Gets CDSCO Panel Nod for Phase IV CT of pulmonary FDC drug

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    New Delhi: Pharmaceutical major, Lupin has got the go ahead from the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) to conduct a Phase IV clinical trial of the fixed-dose combination Mometasone furoate plus Glycopyrronium bromide plus Indacaterol acetate Inhalation Powder This came after the firm presented the Phase IV clinical […] More

  • in Health care

    CDSCO panel grants approval to Akums for PK study of pulmonary FDC

    CDSCO panel grants approval to Akums for PK study of pulmonary FDC

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    New Delhi: Citing that the pharmacokinetic study should be presented before the committee for review, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has granted approval to drug major Akum Pharmaceutical to conduct the pharmacokinetic (PK) study for the fixed-dose combination of the pulmonary drug, Levosalbutamol Sulphate plus Ambroxol […] More

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