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NEW DRUG APPLICATION FILING
Presented By
Simran
M.Pharmacy Ist year
GGSCOP, YNR
Introduction
For decades, the regulation and control of new drugs in the United States has been based on the New Drug
Application (NDA).Since 1938, every new drug has been the subject of an approved NDA before U.S.
commercialization. The data gathered during the animal studies and human clinical trials of an
Investigational New Drug (IND)becomes part of the NDA.
The New Drug Application (NDA) is the vehicle through which drug sponsors formally propose that the
FDA approve a new pharmaceutical for sale and marketing in the United States.
The purpose of a NDA is to provide enough information to permit the FDA to reach the following key
decisions:
•Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh
the risks
•Whether the drug's proposed labeling (package insert) is appropriate and what it should contain
•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.
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 are, the results of the animal studies, how the drug
behaves in the body, and how it is manufactured, processed and packaged.
A new drug application (NDA) can be filed only when the drug successfully passes all three phases of
clinical trials and includes all animal and human data, data analyses, pharmacokinetics of drug and its
manufacturing and proposed labelling. The preclinical, clinical reports and risk-benefit analysis (product's
beneficial effects outweigh its possible harmful effects) are reviewed at the Centre for Drug Evaluation
and Research by a team of scientists.
If clinical studies confirm that a new drug is relatively safe and effective, and will not pose unreasonable
risks to patients, the manufacturer files a New Drug Application (NDA), the actual request to manufacture
and sell the drug in the United States
New Drug
New drug - A new substance of chemical, biological, or biotechnological origin in bulk or prepared dosage
form used for diagnosis, treatment, mitigation or prevention of any disease or disorder in human or animal
which except during local clinical trial has not been used in the country to any significant extent and during
local clinical trials has not been recognized in the country as effective and safe for the proposed claims.
•New Drug Application (NDA) - An application submitted by the manufacturer 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 drug.
Objective of NDA
•Whether the drug's proposed labeling (package insert) is appropriate, and what it should contain.
•Whether the drug is safe and effective in its propose use, and whether the benefits of the drug outweigh the
risks .
•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.
NDA Form
•Form FDA-356h - Application to market a new drug, biological or an antibiotic drug for human use.
•Form FDA 3397 - User fee cover sheet.
•Form FDA 3331 - New drug application field report.
•Required specification for FDAs IND, and ANDA drug master file binders.
The NDAto be submitted to FDAis prepared in multiple copies:
a. Archival copy:
I. It contains all sections of the NDA, Cover letter, Form 356 h, 4 copies of the Labeling section.
II. Three additional copies of CMC (Chemistry, manufacture and control) and methods validation package.
III. Should contains Case report tabulation & case report forms.
b. Review copy:
I. Intended for reviewers in the corresponding technical disciplines.
II. Includes the cover letter, form FDA-356h, NDA index, individual table of contents, labeling section and
application summary.
c. Field copy:
I. It required since 1993 for use by FDA inspectors during pre-approval facilities inspections.
II. In addition to the content of review copy it includes the CMC and method validation package.
NDA may have as many as 20 different sections.
Content of every NDA may be variable based upon nature of drug and volume of information available at
the time of submission
Form FDA-356 h serves as a checklist as well as certification that the sponsor agrees to comply with legal
requirements
NDA sections are described below;
Section 1: Overall NDA index
It is a comprehensive table of contents that enables the reviewers to find specific information in this massive
document quickly. enables the reviewers to find specific
It should follow immediately after the Form FDA-356h.
It must show the location of every section in the archival NDA by volume and by page number.
It should guide reviewers the data in technical sections, summary and supporting documents.
Section 2: Labeling
It must include label that is intended for use on the product container, cartons or packages.
It also includes proposed package insert.
Section 3: Application summary
It is an abbreviated version of the entire application which gives a clear idea of the drug and its applications
Summary usually consist of 50 to 200 pages.
It essentially includes foreign marketing history
Section 4: chemistry, manufacturing, and control (CMC)
Information must includes Description of drug substance or active ingredient: appearance, color, odor,
crystalline form, melting point, boiling point, refractive index, viscosity etc.
Stability
Physical & chemical characteristics solubility, ionization constant, partition coefficient etc.
Names/designation of drug substance(IUPAC) .This section provides a structural overview on molecular
weight, molecular structure, molecular formula.
The section of drug product packaging must include:
Listing of packaging components and supplier
Specifications for each packaging component
Description of packaging process, test methods
Method validation of package is a final component of the CMC technical section, which consist of specifications
and test methods for each component, name and address of suppliers of container, closure system.
Section 5: Non-clinical pharmacology & toxicology
It provides a description of all animal and in vitro studies with the drug including pharmacology, toxicology
& ADME studies.
For the Pharmacology studies, following data is required:
Effect related to the therapeutic indication
Adverse effect
Section 6: Human pharmacokinetics and bioavailability
This technical section includes data from phase 1 studies in healthy volunteers and ADME studies.
It should include parameters such as
1.Peak plasma concentration (Cmax)
2.Area under curve (AUC)
3.Time to reach peak concentration (max)
4.Volume of distribution (Vd))
5.Plasma de renal clearance
6.Urinary excretion
Section 7 Microbiology
This section is mainly useful for antimicrobial drugs those are intended to affect microbial physiology.
In vitro and in vivo studies are critical in establishing the new drug’s effectiveness.
Section 8: Clinical data
It includes
i. List of investigators, list of IND and NDA: include all investigators who have used any dosage form,
alphabetical list of investigator’s and their address, type of study, its location in the NDA.
ii. Background or overview of clinical Investigations
iii. Clinical trials
iv. Controlled clinical trials
v. Analytical data
vi. Uncontrolled clinical trials
vii. Drug abuse and over dose information
Section 9: Safety update data
It includes
i. Contraindications includes description of situation in which the drug should not be used
ii. Warnings: description of serious adverse reaction, limitation in use and steps that should take if they
occur.
iii. Precautions: information regarding any special care to be taken for safe and effective use of drug.
iv. Adverse effect: description of undesirable effects associates with the proper use of the drug
Section 10: statistical data it contain all generated statistical data which can be use to claim safety of drug.
Section 11: case report tabulation it contains data from clinical pharmacology studies and safety data from
all studies in tabulated form.
Section 12: Case report form it includes information regarding any patient who died during a clinical study
or who did not complete the study because of adverse effect, report must be submitted.
Section 13: Patient information
Section 14: Patient certification
Section 15: Establishment description
Section16: Debarment certification
Section 17: Field copy certification
Section 18: User free cover sheet (Form FDA-3397)
Section 19: Financial disclosure (Form FDA 3454, form FDA-3455)
Section 20: Other/pediatric use.
Regulation of drug approval process
DRUG
DISCOVERY
COMPLIANCE WITH REGULATORY REQUIREMENT IS
NECESSARY
DRUG
DEVELOPMENT;
MANUFATURING
CLINICAL TRIALS
IN HUMAN
MARKETING
APPLICATION
Flow chart of New DrugApplication
ThankYou…

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New Drug Application (NDA) Filing

  • 1. NEW DRUG APPLICATION FILING Presented By Simran M.Pharmacy Ist year GGSCOP, YNR
  • 2. Introduction For decades, the regulation and control of new drugs in the United States has been based on the New Drug Application (NDA).Since 1938, every new drug has been the subject of an approved NDA before U.S. commercialization. The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND)becomes part of the NDA. The New Drug Application (NDA) is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the United States. The purpose of a NDA is to provide enough information to permit the FDA to reach the following key decisions: •Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks •Whether the drug's proposed labeling (package insert) is appropriate and what it should contain •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.
  • 3. 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 are, the results of the animal studies, how the drug behaves in the body, and how it is manufactured, processed and packaged. A new drug application (NDA) can be filed only when the drug successfully passes all three phases of clinical trials and includes all animal and human data, data analyses, pharmacokinetics of drug and its manufacturing and proposed labelling. The preclinical, clinical reports and risk-benefit analysis (product's beneficial effects outweigh its possible harmful effects) are reviewed at the Centre for Drug Evaluation and Research by a team of scientists. If clinical studies confirm that a new drug is relatively safe and effective, and will not pose unreasonable risks to patients, the manufacturer files a New Drug Application (NDA), the actual request to manufacture and sell the drug in the United States
  • 4. New Drug New drug - A new substance of chemical, biological, or biotechnological origin in bulk or prepared dosage form used for diagnosis, treatment, mitigation or prevention of any disease or disorder in human or animal which except during local clinical trial has not been used in the country to any significant extent and during local clinical trials has not been recognized in the country as effective and safe for the proposed claims. •New Drug Application (NDA) - An application submitted by the manufacturer 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 drug.
  • 5. Objective of NDA •Whether the drug's proposed labeling (package insert) is appropriate, and what it should contain. •Whether the drug is safe and effective in its propose use, and whether the benefits of the drug outweigh the risks . •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.
  • 6. NDA Form •Form FDA-356h - Application to market a new drug, biological or an antibiotic drug for human use. •Form FDA 3397 - User fee cover sheet. •Form FDA 3331 - New drug application field report. •Required specification for FDAs IND, and ANDA drug master file binders.
  • 7. The NDAto be submitted to FDAis prepared in multiple copies: a. Archival copy: I. It contains all sections of the NDA, Cover letter, Form 356 h, 4 copies of the Labeling section. II. Three additional copies of CMC (Chemistry, manufacture and control) and methods validation package. III. Should contains Case report tabulation & case report forms. b. Review copy: I. Intended for reviewers in the corresponding technical disciplines. II. Includes the cover letter, form FDA-356h, NDA index, individual table of contents, labeling section and application summary.
  • 8. c. Field copy: I. It required since 1993 for use by FDA inspectors during pre-approval facilities inspections. II. In addition to the content of review copy it includes the CMC and method validation package. NDA may have as many as 20 different sections. Content of every NDA may be variable based upon nature of drug and volume of information available at the time of submission Form FDA-356 h serves as a checklist as well as certification that the sponsor agrees to comply with legal requirements
  • 9. NDA sections are described below; Section 1: Overall NDA index It is a comprehensive table of contents that enables the reviewers to find specific information in this massive document quickly. enables the reviewers to find specific It should follow immediately after the Form FDA-356h. It must show the location of every section in the archival NDA by volume and by page number. It should guide reviewers the data in technical sections, summary and supporting documents. Section 2: Labeling It must include label that is intended for use on the product container, cartons or packages. It also includes proposed package insert.
  • 10. Section 3: Application summary It is an abbreviated version of the entire application which gives a clear idea of the drug and its applications Summary usually consist of 50 to 200 pages. It essentially includes foreign marketing history Section 4: chemistry, manufacturing, and control (CMC) Information must includes Description of drug substance or active ingredient: appearance, color, odor, crystalline form, melting point, boiling point, refractive index, viscosity etc. Stability Physical & chemical characteristics solubility, ionization constant, partition coefficient etc. Names/designation of drug substance(IUPAC) .This section provides a structural overview on molecular weight, molecular structure, molecular formula.
  • 11. The section of drug product packaging must include: Listing of packaging components and supplier Specifications for each packaging component Description of packaging process, test methods Method validation of package is a final component of the CMC technical section, which consist of specifications and test methods for each component, name and address of suppliers of container, closure system.
  • 12. Section 5: Non-clinical pharmacology & toxicology It provides a description of all animal and in vitro studies with the drug including pharmacology, toxicology & ADME studies. For the Pharmacology studies, following data is required: Effect related to the therapeutic indication Adverse effect Section 6: Human pharmacokinetics and bioavailability This technical section includes data from phase 1 studies in healthy volunteers and ADME studies.
  • 13. It should include parameters such as 1.Peak plasma concentration (Cmax) 2.Area under curve (AUC) 3.Time to reach peak concentration (max) 4.Volume of distribution (Vd)) 5.Plasma de renal clearance 6.Urinary excretion Section 7 Microbiology This section is mainly useful for antimicrobial drugs those are intended to affect microbial physiology. In vitro and in vivo studies are critical in establishing the new drug’s effectiveness.
  • 14. Section 8: Clinical data It includes i. List of investigators, list of IND and NDA: include all investigators who have used any dosage form, alphabetical list of investigator’s and their address, type of study, its location in the NDA. ii. Background or overview of clinical Investigations iii. Clinical trials iv. Controlled clinical trials v. Analytical data vi. Uncontrolled clinical trials vii. Drug abuse and over dose information
  • 15. Section 9: Safety update data It includes i. Contraindications includes description of situation in which the drug should not be used ii. Warnings: description of serious adverse reaction, limitation in use and steps that should take if they occur. iii. Precautions: information regarding any special care to be taken for safe and effective use of drug. iv. Adverse effect: description of undesirable effects associates with the proper use of the drug
  • 16. Section 10: statistical data it contain all generated statistical data which can be use to claim safety of drug. Section 11: case report tabulation it contains data from clinical pharmacology studies and safety data from all studies in tabulated form. Section 12: Case report form it includes information regarding any patient who died during a clinical study or who did not complete the study because of adverse effect, report must be submitted. Section 13: Patient information Section 14: Patient certification Section 15: Establishment description
  • 17. Section16: Debarment certification Section 17: Field copy certification Section 18: User free cover sheet (Form FDA-3397) Section 19: Financial disclosure (Form FDA 3454, form FDA-3455) Section 20: Other/pediatric use.
  • 18. Regulation of drug approval process DRUG DISCOVERY COMPLIANCE WITH REGULATORY REQUIREMENT IS NECESSARY DRUG DEVELOPMENT; MANUFATURING CLINICAL TRIALS IN HUMAN MARKETING APPLICATION
  • 19. Flow chart of New DrugApplication
  • 20.