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Ind (investigational new drug application) and nda

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Ind (investigational new drug application) and nda

  1. 1. INDIND (Investigational New Drug Application) && NDANDA (New Drug Application) Presented by: Swati Sarin
  2. 2. DRUG DEVELOPMENT  Development of a new therapeutic drug is a complex, lengthy and expensive process  costs nearly 900 million dollars and an average of 15 years.
  3. 3. THE TWO TRANSLATIONALTHE TWO TRANSLATIONAL BLOCKSBLOCKS Basic Biomedical Research Clinical Science and Knowledge Goal: Improved Health Translation from basic science to human studies Translation of new knowledge into clinical practice
  5. 5. INDIND (Investigational(Investigational New DrugNew Drug Application)Application)
  6. 6. IND (Investigational New Drug Application)  FDA's role in the development of a new drug begins when the drug's sponsor has screened the new molecule for pharmacological activity and acute toxicity potential in animals, wants to test its diagnostic or therapeutic potential in humans  The molecule changes in legal status under the Federal Food, Drug, and Cosmetic Act and becomes a new drug subject to specific requirements of the drug regulatory system  Drug is to be the subjected to an approved marketing application before it is transported or distributed across state lines  IND- notice of claimed investigational exemption for a new drug must be filed with regulatory body
  7. 7. TYPES OF INDTYPES OF IND  Investigator IND o Submitted by a physician who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. o Physician might submit a research IND to propose studying an unapproved drug, or an approved product for a new indication or in a new patient population  Emergency Use IND o  Allows FDA to authorize use of an experimental drug in an emergency situation o Does not allow time for submission of an IND in accordance with  21CFR , Sec. 312.23 or Sec. 312.34  Treatment IND o Submitted for experimental drugs showing promise in clinical testing for serious or immediately life-threatening conditions while the final clinical work is conducted and the FDA review takes place
  8. 8. CLASSIFICATION OF INDCLASSIFICATION OF IND  Commercial o Permits sponsor to collect data on clinical safety and effectiveness needed for application for marketing in the form of NDA  Research (non-commercial) o Permits the sponsor to use drug in research to obtain advanced scientific knowledge of new drug o No plan to market the product
  9. 9. CONTENT OF INDCONTENT OF IND In three broad areas:  Animal Pharmacology and Toxicology Studies – o An assessment as to whether the product is reasonably safe for initial testing in humans o Any previous experience with the drug in humans  Manufacturing Information o composition, manufacturer, stability, and controls used for manufacturing the drug  Clinical Protocols and Investigator Information o Commitments to obtain informed consent from the research subjects, to obtain review of the study by an institutional review board (IRB), and to adhere to the investigational new drug regulations. Once the IND is submitted, the sponsor must wait 30 days30 days before initiating any clinical trials.  During this time, FDA  has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk
  10. 10. FORMAT OF INDFORMAT OF IND A. Cover sheet (Form FDA-1571) o Name, address, telephone of sponsor o Identification of phases o Commitment not to begin CT until IND approval o Commitment by IRB- Form 56 o Commitment for conducting CT- accordance with regulations o Name, title – Monitor o Name, title – person(s) for reviewing o Name, Address of CRO, if any o Signature of sponsor B. Table of contents C. Introductory statement & general investigational plan D. Investigators brochure E. Study protocol F. Investigator facilities & IRB data G. Chemistry manufacturing & control data H. Pharmacology & toxicology data I. Previous human experience
  11. 11. RESOURCES FOR INDRESOURCES FOR IND APPLICATIONSAPPLICATIONS • Pre-Investigational New Drug Application (IND) Consultation Pr o Offered by CDER (Center for Drug Evaluation and Research) to foster early communications between sponsors and new drug review divisions in order to provide guidance on the data necessary to warrant IND submission. • Guidance Documents for INDs o documents are prepared for FDA review staff and applicants/sponsors to provide guidelines to the processing, content, and evaluation/approval of applications and also to the design, production, manufacturing, and testing of regulated products
  12. 12. GUIDANCE DOCUMENTSGUIDANCE DOCUMENTS For the complete list of CDER guidance, please see theFor the complete list of CDER guidance, please see the Guidance IndexGuidance Index  Safety Reporting Requirements for INDs and BE/BA Studies  CGMP for Phase 1 Investigational Drugs  Exploratory IND Studies  Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well Characterized, Therapeutic, Biotechnology-Derived Products  Q & A - Content and Format of INDs for Phase 1 Studies of Drugs, Including Well- Characterized, Therapeutic, Biotechnology-Derived Products  Bioavailability and Bioequivalence Studies for Orally Administered Drug Products  IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer  Guideline for Drug Master Files A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.  Required Specifications for FDA's IND, NDA, and ANDA Drug Master File Binders  Immunotoxicology Evaluation of Investigational New Drugs
  13. 13. LAWS,REGULATIONS, POLICIES,LAWS,REGULATIONS, POLICIES, PROCEDURESPROCEDURES The Federal Food, Drug, and Cosmetic Act is the basic food and drug law of the U.S The law is intended to assure consumers that foods are pure and wholesome, safe to eat, and produced under sanitary conditions; that drugs and devices are safe and effective for their intended uses; that cosmetics are safe and made from appropriate ingredients; and that all labeling and packaging is truthful, informative, and not deceptive.
  14. 14. LAWS,REGULATIONS, POLICIES,LAWS,REGULATIONS, POLICIES, PROCEDURES Cont…..PROCEDURES Cont…..  Code Of Federal Regulations (CFR) o The final regulations published in the Federal Register (daily published record of proposed rules, final rules, meeting notices, etc.) are collected in the CFR.  o The CFR is divided into 50 titles that represent broad areas subject to Federal regulations.  o The FDA's portion of the CFR interprets the The Federal Food, Drug, and Cosmetic Act and related statutes.  Section 21 of the CFR contains most regulations pertaining to food and drugs.     21CFR Part 312 Investigational New Drug Application 21CFR Part 314 INDA and NDA Applications for FDA Approval to Market a New Drug (New Drug Approval) 21CFR Part 316 Orphan Drugs 21CFR Part 58 Good Lab Practice for Nonclinical Laboratory [Animal] Studies 21CFR Part 50 Protection of Human Subjects 21CFR Part 56 Institutional Review Boards 21CFR Part 201 Drug Labeling 21CFR Part 54 Financial Disclosure by Clinical Investigators
  15. 15. LAWS,REGULATIONS, POLICIES,LAWS,REGULATIONS, POLICIES, PROCEDURES Cont…..PROCEDURES Cont….. CDER's Manual of Policies and Procedures (MaPPs) MaPPS are approved instructions for internal practices and procedures followed by CDER staff to help standardize the new drug review process and other activities.
  17. 17. Guidance for preparation of INDGuidance for preparation of IND Reference to document: http://www.fda.gov/cder/regulatory/applicat ions/ind_page_1.htm
  19. 19. NDANDA (New Drug Application)(New Drug Application) The vehicle through which drug sponsors formally propose that the regulatory body approve a new pharmaceutical for sale and marketing. Form 44 The data gathered during the animal studies and human clinical trials of an Investigational new product become part of the NDA.
  20. 20. GOAL OF NDAGOAL OF NDA Provide enough information to permit FDA reviewers to establish the following:  Safety & effectiveness of drug?  Benefits overweigh risks?  Is the drug’s proposed labelling (package insert) appropriate, and what should it contain?  Are the methods used in manufacturing (Good Manufacturing Practice, GMP) the drug and the controls used to maintain the drug’s quality adequate to preserve the drug’s identity, strength, quality, and purity? Risk Benefit
  21. 21. NDA CONTENTSNDA CONTENTS 1. Introduction o Brief description of the drug and the therapeutic class to which it belongs 2. Chemical and pharmaceutical information 3. Animal Pharmacology 4. Animal Toxicology 5. Human/Clinical Pharmacology phase I 6. Therapeutic exploratory trials (Phase II) 7. Therapeutic confirmatory trials (Phase III) 8. Special Studies o Geriatrics, pediatrics, pregnant or nursing women 9. Regulatory status in other countries 10. Prescribing information 11. Samples and Testing Protocol/s
  22. 22.  Once the application is submitted, the FDA has 60 days to conduct a preliminary review which will assess whether the NDA is "sufficiently complete to permit asufficiently complete to permit a substantive review”substantive review”  If everything is found to be acceptable, the FDA will decide if the NDA will get a standard or accelerated review and communicate the acceptance of the application and their review choice in another communication known as the 74-day letter74-day letter  A standard review implies an FDA decision within about 10 months10 months
  23. 23. CONTENTS OF ANDACONTENTS OF ANDA Data for a drug already approved in the countryData for a drug already approved in the country 1. Introduction 2. Chemical and pharmaceutical information 3. Marketing information 4. Special studies conducted with approval of Licensing Authority
  24. 24. REQUIREMENTS FOR SIMILARREQUIREMENTS FOR SIMILAR PRODUCTSPRODUCTS GENERIC DRUGS  Drug product that is comparable to any innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use but is produced & distributed without patent application.  This drug have already been approved via an NDA submitted by another maker are approved via an Abbreviated New Drug Application (ANDA), which does not require all of the clinical trials normally required for a new drug in an NDA o No need for preclinical and clinical data o Bioequivalence
  25. 25. REQUIREMENTS FOR SIMILARREQUIREMENTS FOR SIMILAR PRODUCTS Cont….PRODUCTS Cont…. BIOLOGICS  Biologics such as vaccines and many recombinant proteins used in medical treatments are generally approved by FDA via a Biologic License Application (BLA), rather than an NDA.  Manufacture of biologics is considered to differ fundamentally from that of less complex chemicals, requiring a somewhat different approval process.
  26. 26. REQUIREMENTS FOR SIMILARREQUIREMENTS FOR SIMILAR PRODUCTS Cont….PRODUCTS Cont…. MEDICAL DEVICES  Medical devices are approved by a variety of methods depending on the class of the device  Class I: Devices that do not require premarket approval Eg; Dental flossEg; Dental floss  A Pre-market Application (PMA) largely equivalent to an NDA is required for class III devices.These tend to be devices that are permanently implanted into a human body or may be necessary to sustain life. Eg; artificial heartEg; artificial heart  510(k) approval that shows the device is equal to or better than a predicate device already on the market is required for class II devices. Eg;Eg;Diagnostic tests, cardiac catheters, and amalgam alloysDiagnostic tests, cardiac catheters, and amalgam alloys used to fill cavities, hearing aidsused to fill cavities, hearing aids
  27. 27. REQUIREMENTS FOR SIMILARREQUIREMENTS FOR SIMILAR PRODUCTS Cont….PRODUCTS Cont…. Drugs for life threatening/serious disease/relevance to India Clinical and toxicological data may be abbreviated, deferred or omitted as per the licensing authority
  29. 29. REFERENCESREFERENCES http://www.hhs.gov http://www.fda.gov/regulatoryinformation/legisla tion/federalfooddrugandcosmeticactfdcact Gupta S. K; Basic principles of clinical research and methodology.