![USFDA
It is an agency of the united states department of health and human services
(HHS)
Its headquarter located at White Oak, Maryland
The agency also has 223 field offices and13 laboratories located throughout
the 50 states of USA.
FDA started opening office in foreign countries including China ,India , Costa
Rica , Chile , Belgium and UK.
5
Tabor MD E. Review of Pharmaceutical Competitive Intelligence for the Regulatory Affairs Professional. Drug Inf J [Internet].
2012;46(6):745–6.](https://image.slidesharecdn.com/andareviewprocess-180405173523/85/Anda-review-process-5-320.jpg)
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Laws, Regulations and Part in Code of Federal regulations
Sr. No. Regulation Part Purpose
1 21 CFR 312
Investigational New Drug
Application
2 21 CFR 314
INDA and NDA Applications for
FDA Approval to Market a New
Drug
3 21 CFR 316 Orphan Drugs
4 21 CFR 58
Good Lab Practice for Nonclinical
Laboratory [Animal] Studies.
7 21 CFR 201 Drug Labeling
9 21 CFR 320
Bioavailability and
Bioequivalence
10 21 CFR 310 New Drugs
New Drug Approval Process, Richard Gaurino, Marcel Dekker INC, New York, 2nd Edition, Vol.56, 189-212.](https://image.slidesharecdn.com/andareviewprocess-180405173523/85/Anda-review-process-7-320.jpg)
Anda review process
- 1. Review Process of 505 b (1), 505 b(2), 505 (j) IN USA Prepared By: Guided By: Chandani Tripathi Dr. Gayatri Patel 17MPHRA010 Associate Professor 1
- 2. TABLE OF CONTENT INTRODUCTION 21 CFR Organization of USFDA Organization of CDER Types of Application FDA Meetings RA Due Diligence PDUFA IN IND AND NDA REVIEW PROCESS INDA AND NDA REVIEW PROCESS GDUFA IN ANDA REVIEW PROCESS ANDA REVIEW PROCESS SUMMARY REFERENCES 2
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- 4. INTRODUCTION Drugs play a vital role in modern day treatment strategies. The term ‘drug’ is derived for the French word “Drogue” that means dry herb. FDA provides scientific and regulatory advice needed to bring new therapies to market. Centers for Drug Evaluation and Research (CDER) supports the pharmaceutical industry at every step in the process of innovation and development of new drugs. 4 New Drug Approval Process, Richard Gaurino, Marcel Dekker INC, New York, 2nd Edition, Vol.56, 12-20.
- 5. USFDA It is an agency of the united states department of health and human services (HHS) Its headquarter located at White Oak, Maryland The agency also has 223 field offices and13 laboratories located throughout the 50 states of USA. FDA started opening office in foreign countries including China ,India , Costa Rica , Chile , Belgium and UK. 5 Tabor MD E. Review of Pharmaceutical Competitive Intelligence for the Regulatory Affairs Professional. Drug Inf J [Internet]. 2012;46(6):745–6.
- 6. 21 CFR (Code of Federal Regulation) USA—CODE OF FEDERAL REGULATIONS 21---Pharmaceutical Only 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations Establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). 6Development & The US FDA. 2011;
- 7. 7 Laws, Regulations and Part in Code of Federal regulations Sr. No. Regulation Part Purpose 1 21 CFR 312 Investigational New Drug Application 2 21 CFR 314 INDA and NDA Applications for FDA Approval to Market a New Drug 3 21 CFR 316 Orphan Drugs 4 21 CFR 58 Good Lab Practice for Nonclinical Laboratory [Animal] Studies. 7 21 CFR 201 Drug Labeling 9 21 CFR 320 Bioavailability and Bioequivalence 10 21 CFR 310 New Drugs New Drug Approval Process, Richard Gaurino, Marcel Dekker INC, New York, 2nd Edition, Vol.56, 189-212.
- 8. ORGANIZATION OF USFDA 8 Office of Commissioner Center for Drug evaluation and Research (CDER) Center for devices and Radiological Health Center for Vertinary medicine Cenetr for food safety and applied Nutrition Center for toxicological research Administrative Law Judge Office of equal opportunity and management Office of Health and Science Office of Regulatory affairs Office of International Activities Office of management www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/investigationalnew drugindapplication/default.html (D.O.A: 08-03-18)
- 9. TYPES OF APPLICATION 9 Investigational New Drug (IND) and New Drug Application (NDA) Abbreviated New Drug Application (ANDA) Over-the-Counter Drugs (OTC) Biologic License Application (BLA) Supplemental New Drug Application (SNDA) Services H, Information A, Description P. Food and Drug Administration APPLICATION TO MARKET A NEW OR ABBREVIATED NEW. (910):7–9.
- 10. TYPES OF MEETING 1) Type A Meeting : Always within 30 days of a written meeting request. Is a meeting required to help an otherwise stalled product development E.g: To discuss clinical holds in which a response to hold issues has been submitted. 2) Type B Meeting : within 60 days For concurrent development of a product for unrelated claims. E.g: (pre-IND) meetings (21 CFR 312.82) Certain end-of-phase 1 meetings (21 CFR 312.82) 10
- 11. 3) Type C Meeting : within 75 days Is a meeting between CBER or CDER and a sponsor or applicant regarding the development and review of a product. 11 FDA. Guidance for Industry: Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants (draft). 2013;(910):1–14.
- 12. RA DUE DILIGENCE The process of investigating an investment or partnering opportunity to mitigate risk is called as Due Diligence. The probability of success and a forecast of sales. WHEN???? Performed prior to investing money in a deal or getting involved in a partnership arrangement. Special key team member-----To identify potential weaknesses that might develop into deal-breaking problems. 12Ebel A. Due diligence of R&D Projects - a guideline for evaluating regulatory aspects. 2009;
- 13. Steps in RA Due Diligence: 1) Identify potential partner 2) Preliminary DD team members develop a forecast to generate discussion around deal terms. 3) Agreement on the outline deal terms. 4) An information requirement list is sent to the potential partner. 5) A core due diligence team is assembled (external consultants can be utilized, if necessary). 13
- 14. PDUFA (Prescription Drug User Fee Act ) Passed in 1992 To meet urgent patient demands for more timely approvals of life-saving treatments and cures. To protect and promote the public health. PDUFA works to make review process easier more efficient. ROLE ????? Enhanced the FDA’s access to tools, processes and expertise, with the latest scientific advances. Helps in the development of new medicines to patients by providing scientific and regulatory predictability. 14 Services H, Information A, Description P. Food and Drug Administration APPLICATION TO MARKET A NEW OR ABBREVIATED NEW. (910):7–9.
- 15. Bio pharmaceutical companies pay three different user fees under PDUFA: 15 Application fees: The initial fee when a sponsor submits a New Drug Application (NDA) or Biologics License Application (BLA) for the first time. Product fees: Annual fee for marketed drugs for which no generic versions are approved. Establishment fees: Final fee for each manufacturing site that manufactures at least one approved prescription drug for which no generic versions are approved. Services H, Information A, Description P. Food and Drug Administration APPLICATION TO MARKET A NEW OR ABBREVIATED NEW. (910):7–9.
- 16. 505 b (1) & 505 b (2) Review Process 505 b (1) is specially for ‘Investigational New Drug’ under 21 CFR 312.3 (b) (US FDA) After IND submission----- the sponsor must wait 30 days before initiating any clinical trials. The studies in human can begin only after an IND is reviewed by the FDA and “Local Institution Review Board” (IRB). Review Team: The team composed of members of different disciplines (e.g., Medical Officer, Project manager, Chemist, Pharmacologist, Microbiologist Biopharmaceutical, Statistician 16 Kaur J. Research Article US FDA Drug Approval Strategies for Pharmaceutical Industry. 2014;25(24):137–46.
- 17. 17 Applicant Form---1571 IND CDER REVIEW Safety Review Review Complete and acceptable No deficiences Study Continue NDAApplication Notify deficiency to applicant Safety acceptable to proceed Chemical Hold Decision Notify applicant Medicinal Chemistry Pharmacological/ Toxicological Statistical NO YES NO YES NO
- 18. 18 Applicant Form---356 h NDA Application Fillable CDER REVIEW Review complete and acceptable Labelling review acceptable Inspection of site acceptable Request for additional information or revision Acceptable Further Discussion for Approval satisfactory results pending NDA Approved Medicinal Biopharmaceutical Pharmacological/ Toxicological Chemistry Microbiological Statistical Advisory Committee Meeting with sponser Refuse to file the NDA NO YES NO YES YES NO NO
- 19. The review copy is divided into six technical sections (“review sections”) 19 Chemistry, Manufacturing and Controls (CMC) – RED. Nonclinical Pharmacology and Toxicology – YELLOW. Human Pharmacokinetics and Bioavailability – ORANGE. Microbiology (if required) – WHITE. Clinical Data –LIGHT BROWN. Statistical – GREEN Kaur J. Research Article US FDA Drug Approval Strategies for Pharmaceutical Industry. 2014;25(24):137–46.
- 20. GDUFA (Generic Drug User Fee Act) Law designed to speed access to safe and effective generic drugs to the public, and reduce costs to industry. GDUFA is needed for the growth in generic drug applications GDUF will focuses on three key aims: 20 Access Transparency Safety http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM525236.pdf (D.O.A: 05-03-18)
- 21. To keep coordination and integrity of the products. GDUFA applies for four types of fees: 21 1 •Application Fees: This is the first time fee, it is to be provided when applying for the generic drug for the very first time to the FDA. 2 •DMF Fees: A DMF a one- time fee. The first time ANDA or DMF filled after October 1, 2012, whether or not the DMF were reviewed prior to GDUFA implementation. 3 •New ANDA Filing Fees: New application of ANDA filling after October 1, 2012. 4 •Backlog Fees: A one-time application fee for ANDAs that were pending and had not received tentative approval prior to October 1, 2012. Services H. ANDA Submissions – Prior Approval Supplements Under GDUFA Guidance for Industry ANDA Submissions — Prior Approval Supplements Under GDUFA Guidance for Industry. 2017;(October).
- 22. 505 (j) Review Process 505 (j) stands for Generic Drugs. Also known as “Abbreviated New Drug Application” (ANDA) It was introduced in 1984. On Friday, January 16, 2009, “Final rule” on the requirements for submission of Bioequivalence Data was published in the Federal Register. 21CFR Part 320 Bioavailability and Bioequivalence Requirements. ANDA aims on the three areas: 1)Formulations and manufacturing, 2)container integrity and packaging, and 3) stability and expiration. 22 www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/default.htm (D.O.A: 09-03- 2018)
- 23. 23 Applicant Form--- ANDA Application Fillable OGD/ CDER REVIEW Review complete of each data Bioequivalence acceptable Bioequivalence deficiency letter Chemical/Microbiological results acceptable Not approved deficiency letter Pre-approval Inspection Pending Satisfactory ResultsANDA Approved Bioequivalence Review Chemistry/Microbiological Review Pharmacological/ Toxicological Statistical Advisory Committee Meeting with sponsor Refuse to file the NDA NO YES YES NONO YES NO YES
- 24. SUMMARY The USFDA Drug Approval Strategies for Pharmaceutical Industries communicate about the approval for drug products. It is necessary to understand the various steps for drug approval. FDA provides scientific and regulatory advice needed to bring new therapies to market. 24
- 25. REFERENCES New Drug Approval Process, Richard Gaurino, Marcel Dekker INC, New York, 2nd Edition, Vol.56, 189-212. www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandappro ved/approvalapplications/abbreviatednewdrugapplicationandagenerics/default.ht m(D.O.A:13-03-2018) www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/default.htm (D.O.A: 09- 03- 2018) Kaur J. Research Article US FDA Drug Approval Strategies for Pharmaceutical Industry. 2014;25(24):137–46. FDA. Guidance for Industry: Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants (draft). 2013;(910):1–14. Ebel A. Due deligence of R&D Projects - a guideline for evaluating regulatory aspects. 2009; Services H. ANDA Submissions – Prior Approval Supplements Under GDUFA Guidance for Industry ANDA Submissions — Prior Approval Supplements Under GDUFA Guidance for Industry. 2017;(October). Services H, Information A, Description P. Food and Drug Administration APPLICATION TO MARKET A NEW OR ABBREVIATED NEW. (910):7–9. 25
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