NEW DRUG APPLICATION :
NDA is the regulation and control of new drug in U.S.
Definition:”NDA is the vehicle through which drug sponsors formally propose that the FDA approval for new drug sales and marketing in the united states.”
21 CFR PART 314 TITLE application for FDA approval to market a new drug.
Purpose/Goal of NDA: purpose of NDA is to provide enough information to permit FDA to reach the following key decisions.
Sponsor has to prove that,
-whether drug is safe and effective
-benefits outweigh the risks
-whether drug has appropriate package insert and what it should contains.
-Whether the drug manufactured according to GMP to preserve the drugs identity ,strength and purity.
NDA suppose to tells drugs whole story .
-it includes what happened during clinical studies,
-what ingredients are used for drug,
-results of non clinical studies,
-how drug behaves in the body
-how it is manufactured, processed and packed.
For FDA drug approval and review time for drug application is under the act of PDUFA(prescription drug user fee act) review time goals are established under PDUFA.for priority NDA FDA review time is 6 months and standard NDA review time is 10-12 months. Regulation for accelerated review for serious illness or life threating illness are codified in 21 CFR 314 subpart H.
Contents of NDA:
3.cemistry,manufacturing and control
4. samples, methods validation and labeling
5preclinical studies results and toxicology
6human pharmacokinetics and bioavailability
8.clinical data results
9.safety updated report
11.case report tabulation
12.case report forms
NDA review process:
-FDA takes 60dasys for preliminary reviews.
-sponsor submit application to NDA,it is filable.if all the documents are enough it is acceptable and a letter form with in 74 days intimate to the sponsor. if it is rejected return to file letter to the sponsor.
-the filed drug is under CDER going for further review i.e having different research branches like medical,chemistry,biology,biopharmaceutical etc.if outcome results are acceptable it will undergoes labeling and inspection of site review. all the results are safe which outweigh the risks NDA approve the post marketing of new drug.