nda

NEW DRUG APPLICATON

1. NDA (New Drug Application)

2. Since 1938 in U.S. A vehicle for approval of New Drugs

3. NDA is a … A formal proposal of Sponsor to the FDA for the granting the Marketing & Sale Approval of their new pharmaceutical. A narrative of the Drug Ingredients Manufacture, processing, packaging Non clinical data Clinical data P’cokinetics & dynamics

4. Why NDA??? Safety & Efficacy, risk benefit ratio Proposed labeling (Package Insert)scrutinized Whether the methods used in manufacturing the drug and the controls used to maintain the drug's quality are adequate to preserve the drug's identity, strength, quality, and purity .

5. 21CFR part 314 Sub parts A to I subpart A: General Provisions Scope, Purpose & Definitions

6. Subpart B: Applications Content and format of an application. Notice of certification of invalidity or noninfringement of a patent. Submission of patent information. Procedure for submission of an application requiring investigations for approval of a new indication for, or other change from, a listed drug. Pediatric use information . Amendments to an unapproved application . Withdrawal by the applicant of an unapproved application . Supplements and other changes to an approved application. Procedures for submission of a supplement to an approved application. Change in ownership of an application. Postmarketing reporting of adverse drug experiences. Other po stmarketing reports. Waivers .

7. Contents & Format Three copies of the application are required: An archival copy, A review copy , and A field copy.

8. Contents & Format A n application form ( Form FDA-356h ) An index , A summary, Five or six technical sections , Case report tabulations of patient data , case report forms, D rug samples , and labeling, including, if applicable, Any Medication Guide required

9. FDA Review Review period -180 days Three possible outcomes from FDA- Approval Letter Approvable Letter Not Approvable Letter

10. Prescription Drug User Fee Act (PDUFA) On November 21, 1997, The President signed the Food and Drug Administration Modernization Act of 1997.  This legislation includes authorization for FDA to continue to collect three types of user fees from applicants who submit certain new drug and biological product applications.

11. NDA in India Form 44

12. Requirements for the Drug Approval in India Has five Modules Module I: Administrative/Legal Information Module II: Summaries Module III: Quality information (Chemical , pharmaceutical and biological) Module IV: Non-clinical information Module V: Clinical information

13. Application Review Period Remains the same as that of USFDA ____ days

14. Thank You Any Questions to ask???? Or else drop them in this mail id. [email protected]