Examples of 'drug submission' in a sentence
Meaning of "drug submission"
Drug submission refers to the process of submitting a new drug application (NDA) or a generic drug submission to the appropriate regulatory authority, such as the Food and Drug Administration (FDA) in the United States. It involves providing comprehensive data and information about the drug's safety, effectiveness, and quality, as well as details of clinical trials and manufacturing processes
How to use "drug submission" in a sentence
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drug submission
Related guidances for drug submission filings.
A new drug submission submitted for an rbST product.
Target performance standards for drug submission review.
Service standards for drug submission evaluation are relatively comparable.
Supporting data determines application of appropriate drug submission fee.
O drug submission evaluation.
O supplement to a new drug submission.
The New Drug Submission guidance document will be posted in the very near future.
The same process will apply as for any other drug submission.
O A new fee is proposed for drug submission evaluations supported only by published data.
Product monographs are submitted to HPFB as part of a new drug submission.
Carcinogenicity Studies The drug submission did not include data on carcinogenicity toxicity.
These studies are submitted to Health Canada as part of a generic drug submission.
Minister refused to list a patent against a drug submission for a new manufacturing site.
IRP performs a comprehensive screening to evaluate the completeness of the drug submission.
See also
The drug submission for Aptivus was reviewed under the Priority Review Policy.
Health Canada issues such a notice to a company following the satisfactory review of a new drug submission.
O use of electronic drug submission templates ;.
A Type I DMF is reviewed and approved only in connection with a specific drug submission.
O a supplement to a new drug submission for a change in formulation ;.
We also made progress with the New Drug Submission.
The drug submission should contain the following information,.
This is required to complete an eCTD for drug submission to Health Canada.
O abbreviated new drug submission ( or supplement to an abbreviated new drug submission ).
A new measurement system has been instituted for the Drug Submission Review Process.
New drug submission screening form for scientific screeners section a,.
Manufacturers are required to provide Health Canada a detailed Product Monograph with their drug submission.
O a supplement to a new drug submission for a change in dosage form ;.
The T herap eutic Pro ducts Directorate reports statistics regarding the drug submission process.
A new drug submission in the context of clinical studies * is structured in five parts,.
Ferring 's patent was listed on the basis of a drug submission for an additional brand name.
The following drug submission types are eligible for filing in eCTD format,.
Sponsor, the applicant who filed a drug submission with VDD.
The relevant drug submission screening form ( s ) is to be completed by the sponsor where applicable.
Conclusion The non-clinical studies for this drug submission are considered acceptable.
The new drug submission contains information and data about the drug 's safety, usefulness and quality.
This approach could accelerate Canada 's drug submission review times - without jeopardizing safety.
O Drug submission performance is reported quarterly and annually?
The non-proprietary information is reviewed as part of the drug submission that the DMF supports.
The fast drug submission may need high-quality documents, to avoid any rejections from FDA.
Summary and Conclusion The non-clinical studies for this drug submission are considered acceptable.
File a drug submission to Health Canada, and receive approval.
This information was already submitted as part of a New Drug Submission ( NDS ) package.
O Stakeholder requests for improved drug submission review performance, and improved measurement and reporting ;.
Drug Submission Sponsor The drug submission sponsor is responsible for,.
O preclinical ( investigational ) new drug submission.
Drug Submission Management Update Here we are, at the end of another fiscal year.
The structure of a human new drug submission part 1,.
Veterinary Drug Submission Sponsor The veterinary drug submission sponsor is responsible for,.
Target performance standards for drug submission review appendix 4,.
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Her drug of choice was your drug of choice
Examples of using Submission
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Submission to the commission for environmental cooperation
Time limit for the submission of documents
Submission of audit reports of nationally executed expenditure
