Discovery and development of drug is very much systematic and law guided activity. FDA submission and getting approval to conduct drug development activity is what sponsor place on topmost priority. FDA has been enforced rule for submission of pre-clinical safety study data before conducting trial in human subjects and clinical efficacy data for marketing approval. the formal one is called investigational new drug (IND) and later, new drug application (NDA).
here we are going to discuss about some basic characteristics and differences between these two regulatory submission
- Contents: IND is detail description of all the pre-clinical findings of animal study on particular Investigation new drug (IND) whereas NDA basically requests for permission for marketing of that drug. IND is intended to justify importance of further research in human subject by referring toxicological studies and safety finding, while IND exactly defines how marketing of drug is important for particular disease condition taking into considerations of efficacy finding in human subjects.
- Time of submission: IND application is submitted after toxicological study, to get permission of administering drug in human, while NDA is submitted after closure of multicentric phase III randomized control clinical trial.
- extent of regulation: NDA is tightly regulated in comparison to IND. loose regulation in a sense that sponsor can conduct human study at least after 30 days of IND submission even without response from authority. but after once NDA application, regulatory body has to go series of observation and analysis at multiple level which may take more than a year. duty of manufacturer is within this period is confined to just being available at the time summoned by FDA. US has developed and enforced a separate code of federal regulation ( CFR 21 part 314) for NDA regulations, which every applicants ought to follow.
NOTE: in case FDA gives authority, one can conduct human study before completion of animal study, where IND keeps updating with new safety finding.
- Format for content: this is how IND is formatted:
- single dose toxicity finding in two mammalian species
- safety pharmacological studies to include assessment of effects on vital functions
- pharmacokinetic studies (ADME)
- repeated dose toxicity studies in two species for two or four weeks, providing phase I studies will not exceed two weeks
- local tolerance studies using route of administration relative to proposed clinical administration
- Invitro test for evaluation of mutations and chromosomal damage ( Genotoxicity )
- carcinogenicity studies only if there is cause for concern
major scientific evidences in NDA form:
- formal request for marketing in standard format
- statement that phase III study is completed and necessary safety and efficacy standards are maintained
- summery of final study report
- details of medicinal product, all the site documents along with investigators and sites involved, regulatory procedures followed during study, study protocol, data generated from site.
for further information on 21CFR part 314, please refer to this link; https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=314
- extent of regulation: NDA is tightly regulated in comparison to IND. loose regulation in a sense that sponsor can conduct human study at least after 30 days of IND submission even without response from authority. but after once NDA application, regulatory body has to go series of observation and analysis at multiple level which may take more than a year. duty of manufacturer is within this period is confined to just being available at the time summoned by FDA. US has developed and enforced a separate code of federal regulation ( CFR 21 part 314) for NDA regulations, which every applicants ought to follow.
NOTE: in case FDA gives authority, one can conduct human study before completion of animal study, where IND keeps updating with new safety finding.
- Format for content: this is how IND is formatted:
- single dose toxicity finding in two mammalian species- safety pharmacological studies to include assessment of effects on vital functions
- pharmacokinetic studies (ADME)
- repeated dose toxicity studies in two species for two or four weeks, providing phase I studies will not exceed two weeks
- local tolerance studies using route of administration relative to proposed clinical administration
- Invitro test for evaluation of mutations and chromosomal damage ( Genotoxicity )
- carcinogenicity studies only if there is cause for concern
major scientific evidences in NDA form:
- formal request for marketing in standard format
- statement that phase III study is completed and necessary safety and efficacy standards are maintained
- summery of final study report
- details of medicinal product, all the site documents along with investigators and sites involved, regulatory procedures followed during study, study protocol, data generated from site.
for further information on 21CFR part 314, please refer to this link; https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=314
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