New drug application (NDA).pptx

New drug application submitted by the manufacture of a drug to the FDA-after clinical trials have been completed –for a license to market the drug for a specified.

1. New drug application (NDA). BY: shiva Kant thakur . m. Pharm 1year (pharmaceutics) To : Dr. s . Bharat

2. contents Introduction Nda approval process Review process Advisory committee Confidentiality of information Amiloride case point

3. 1. Introduction :- An application submitted by the manufacture of a drug to the FDA-after clinical trials have been completed –for a license to market the drug for a specified. New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new . Objective of NDA Labeling Safe and effective Drug quality

4. Nda approval process :- The information of drug’s safety and efficacy collected during the animal and human trials during the IND process becomes part of NDA application. NDA must be submitted complete in proper from and with all critical data .

5. All nda’s information :- Index Summary Chemistry, Manufacturing and Control Sample , Methods validation package and Labeling Non clinical pharmacology and toxicology Human Pharmacokinetics and bioavailability Microbiology ( for anti-microbial drugs only)

6. Continue….. Clinical data Safety Update report ( typically submitted 120 days after the NDA’s submission) Statistical section Case Report & Tabulations Patent information Patent Certification Other information

7. Format of application :- 3 copies of the application are required: Archival copy Review copy Field copy Archival copy : it is a complete copy of the application .

8. Continue….. Review copy :- Include the information needed by each review discipline for its evaluation. Quality . Non clinical. Clinical – safety & efficacy documents for clinical reviewer . Clinical – safety & efficacy documents for statistical reviewer. Clinical – clinical pharmacology & pharmacokinetics documents. Clinical – clinical microbiology documents .

9. Continue….. Field copy :- Separately bound copy of the quality section. It is directly send to the appropriate filed office . FDA will maintain guidance document on the format &content of applications to assist applicants in their preparation .

10. 3. Review process :- Under food drug and administration modernisation act depending on the anticipated therapeutic or diagnostic value of submitted NDA, its review might receive priority or standard classification. During the NDA evaluation there is no guidelines or rules that require open communication between FDA and sponaser .

11. Priority review :- the drug product if approved would be a significant improvement compared with marketed products in treatment , diagnosis or prevention of a disease. Standard review :- all non priority applications will be considered standard application . i.e. , application for drugs similar to those on the market are considered standard.

12. Action letter :- An approval latter :- it signifies that all substantive requirements for approval are met with and that the sponsor company can begian marketing the drug as of the date on latter. Approvable latter :- minor deficiencies that must be addressed before an approval letter is sent. Within 10days of receipt sponsor must respond. Non approvable letter :- it signifies that FDA has a major concern with the application and will not approve the proposed drug product for marketing as submitted .

13. Advisory committees :- There is no statutory requirement that FDA review the approval of an NDA with an advisory committee before final action taken . But its an extremely important step in the approval process. It represents the best opportunity that the applicant has to address the agency and the public about the evidence of safety and effectiveness and the importance of the drug to the public health.

14. Confidentiality of information :- In general , no data or information submitted to FDA as part of an IND or NDA will be made public prior to FDA approval or disapproval of the NDA. Even the existence of IND or NDA will be kept confidential by FDA if it has not been disclosed by sponsor. Upon approval , FDA issues a summary of the basis for the agency approval of the product , which describes the safety and effectiveness data on which the agency relied.

15. amiloride However , amiloride was introduced in several European countries & Asian countries. Its excellent tolerance & usefulness, especially when used in combination with hydro Chlorthiazide , led finally to its approval by FDA in 1981.

16. Thank you ………