NDA- New Drug Application process.pptx

Welcome to our informative slide on the New Drug Application (NDA) - a pivotal milestone in the pharmaceutical world that propels medical innovation to new heights. In this concise presentation, we'll explore the significance of the NDA process and its critical role in bringing life-changing medications to patients in need.

1. NDA- New Drug Application Dharmender Yadav YouTube: PHARMA HOTSPOT

2. NEW DRUG APPLICATION NDA stands for " New Drug Application " It is an Application submitted by the sponsor to regulatory authorities, such as the U.S. Food and Drug Administration (FDA), seeking approval to market and sell a new pharmaceutical drug. The NDA includes data from preclinical and clinical studies , as well as information on the drug's safety, efficacy, and manufacturing processes. Approval of an NDA is necessary before the drug can be commercially available to the public.

3. The Drug Development Process IND Application Filling NDA Filling Animal testing of a Drug Pre Clinical studies Short Term FDA Approval Phase-IV Post Marketing Surveillance Clinical studies 20-100 100-300 1000-3000 Individuals individuals individuals Phase-I Phase-II Phase-III 1-2 Years 1-2 Years 2-3 Years Long Term Safety Efficacy Confirm & Safety Safety & efficay Drug Discovery & Development

4. What are New Drugs A drug that contains a new chemical entity as its active ingredient would be considered as a new drug. A drug’s recommended new use or change in recommended dosage, dosage form or route of administration also can be considered to be a new drug.

5. Goals of NDA The goals of the New Drug Application (NDA ) are to provide enough information to permit FDA reviewers to establish the following: Is the drug safe and effective in its proposed use and do the benefits outweigh the risks ? Is the proposed labelling (package inset) is appropriate and what should it contain ? Are the methods used in manufacturing – GMP (Good Manufacturing practice) and the controls used to maintain drug’s quality adequate to preserve its identity, strength, quality and purity.

6. NDA FORMS 1. Form FDA-356h Application to Market a New Drug, Biologic or an Antibiotic drug for Human use. It includes: Applicant information Product/Manufacturing information Pre-clinical studies Clinical studies Labelling

7. NDA FORMS 2. Form FDA-3397 User fee cover sheet FDA has the authority to collect user fees for certain drugs and biologics license applications. Pharmaceutical companies pay for the review of certain new drugs, biologics or supplements. User fee cover provide necessary information that help to determine whether a fee is applicable or not It also helps FDA to track payments.

8. NDA FORMS 3. Form FDA-3331 NDA Field Alert Report FAR (Field Alert Report) is submitted to the FDA when the drug is already distributed in the market and the manufacturer become aware of any information that can affect the identity, quality, strength or potency of the drug. This reporting mechanism is crucial for the FDA to take appropriate actions in addressing potential safety concerns, issuing drug recalls if necessary, and ensuring patient safety.

9. NDA COPIES FDA requires drug sponsors to submit multiple copies of the NDA. ARCHIVAL COPY: The cover letter The administrative section It must contain four copies of labelling section It must contain additional three copies of CMC and methods validation package in a separate binder Only the folder that contains the case report tabulation and case report forms

10. 2. REVIEW COPY: It contains NDA’s technical sections along with the cover letter form FDA-356h, NDA index as well as individual table of content, labelling sections, and application summary. 3. FIELD COPY: It is required by FDA inspectors during pre-approval facilities inspections. In addition to content of review copy, this includes CMC (Chemistry, Manufacturing and Controls) and methods validation package.

11. NDA Contents NDA contains 20 different sections in addition to the form FDA-356h itself. Specific content of NDA will depend on: Nature of the drug Information available at the time of submission.

12. NDA Contents NDA Section 1: Index NDA Section 2: labelling NDA Section3: application summary NDA Section 4: Chemistry , Manufacturing, controls (CMC ) NDA Section 5: Non-clinical pharmacology and Toxicology NDA Section 6: Human pharmacokinetics and Bioavailability NDA Section 7: Microbiology NDA Section 8: clinical data NDA Section 9: Safety Update Reports NDA Section 10: Statistics

13. NDA Contents NDA Section 11: Case Report Form Tabulations NDA Section 12: Case Report Forms NDA Section 13: Patent Information NDA Section 14: Patent Certification NDA Section 15: Establishment Description NDA Section 16: Debarment Certificate NDA Section 17: Field Copy Certification NDA Section 18: User Fee Coversheet NDA Section 19: Financial Disclosure NDA Section 20: others

14. FDA Drug Approval Process The documentation required in an NDA is supposed to tell the drug’s whole story, including: what happened during the clinical tests, what the ingredients of the drug formulation are, the results of the animal studies, how the drug behaves in the body, and how it is manufactured, processed and packaged . Once the Application is submitted, FDA has 60 days to conduct preliminary review which assess whether the NDA is “sufficiently complete to permit a substantive review” . If everything is acceptable FDA decide if the NDA will get standard or accelerated review and communicate the acceptance and review choice in another communication known as 74-day letter. A standard review may take 10 months for decision by FDA reviewers while the decision is made within 6 months in accelerated review.

15. NDA REVIEW PROCESS

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