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Edit Comment Close Premium member Presentation Transcript Product Registration and Drug Approval Process in United States : Product Registration and Drug Approval Process in United States keerthi priya Slide 2: 2 overview Back ground for product registration in the united states The New Drug Application (NDA) and review process Generic drug product registration and review process (ANDA) Post-Approval activities for NDA and ANDA Other considerations for NDA and ANDA Pre-Approval inspection Background for product registration in the United States : Background for product registration in the United States All new drug products must be registered and approved by the regulatory agency governing the intended market before the products can be introduced into the market. The registration process is to ensure the quality, safety, and efficacy of drug products. The requirements for the development and registration of new drug products in the United states are defined in the Federal Food Drug and Cosmetic Act (FD&C Act) and the regulations promulgated by the FDA. Introduction : Introduction The new drug application (N D A) is a critical component in the drug approval process. The NDA contains Clinical and nonclinical test data and analyses, Drug chemistry information, and Descriptions of manufacturing procedures. An NDA consists of thousands of pages of information to be reviewed by FDA teams composed of highly qualified individuals with expertise in their respective technical fields. Introduction : Introduction NDAs and ANDAs are submitted to FDA FDA has complex organisation for review and approval of NDAs and ANDAs. Review and approval are conducted by CDER Which reports directly to the office of commissioner of FDA Within CDER there are number of offices organized under the office of center director. Slide 8: 8 New Drug Application (NDA) Classifications New molecular entity New salt of previously approved drug New formulation of previously approved drug (not a new salt OR a new molecular entity) New combination of two or more drugs Already Marketed Drug Product – Duplication (i.e., new manufacturer) New Indication (claim) for Already Marketed Drug ( includes switch in marketing status from prescription to OTC) Already Marketed Drug Product – No previously Approved NDA Slide 9: six different teams are responsible for reviewing an NDA. The teams are organized by technical reviewing responsibilities: Clinical Pharmacology/toxicology, Chemistry ,Statistics, Biopharmaceutical and Microbiology. The FDA has established guidelines for formatting, assembling, and submitting the NDA. Failure to follow these guidelines can result in deficiencies that could Delay review, Require an amended application, or Result in a refusal to File. In 1997 the FDA’s Center for Drug Evaluation and Research (CDER) published guidelines that allow sponsors to submit NDAs electronically instead of on paper NDA starts with FDA form 356h which provides listing of 20 sections. The Form 356h is completed and signed by the sponsor or the sponsors authorized US agent, who resides or maintains a business site in the United states. Format and content of NDA : Format and content of NDA Index Summary Chemistry, Manufacturing and Control Samples, Methods Validation Package and Labeling Nonclinical Pharmacology and Toxicology 6. Human Pharmacokinetics and Bioavailability 7. Microbiology ( for anti-microbial drugs only) 8. Clinical Data 9. Safety Update report ( typically submitted 120 days after the NDA’s submission ) 10. Statistical 11. Case Report Tabulations Slide 11: 11.Case Report Tabulations 12.Case Report Forms 13. Patent Information 14. Patent Certification 15. Establishment description 16. Debarment certification 17. Field copy certification 18. User fee cover sheet 19. Financial information 20. Other NDA CONTENTS : NDA CONTENTS Section 1: Overall NDA index:- It Provides a guide through the entire application for the FDA reviewers. The index must clearly describe the contents and location of each section by volume and page number. Section 2: Labeling It must include all draft labeling that is intended for use on the product container, cartons or packages, including the proposed package insert. Slide 13: Section 3: Application summary The application summary is an abbreviated version of the entire application. This overview is one of the few elements of the application that all reviewers receive, and it should give them a clear idea of the drug and its application. The summary usually comprises 50 to 200 pages Application Summary The draft product labeling include the following sections 1. Description 2. Clinical Pharmacology 3. Indications and Usage 4. Contraindications 5. Warnings 6. Precautions 7. Adverse Reactions 8. Drug Abuse and Dependence 9. Overdosage 10. Dosage and Administration 11. How Supplied (primary and secondary packages) Slide 14: Section 4: Chemistry, manufacturing and controls Chemistry, Manufacturing, and Controls (CMC) The first technical section of the NDA It includes information on The composition, Manufacturing, and Specifications of the drug substance and the drug product. The three main elements are Chemistry, manufacturing and controls information, Samples, Method validation, package. Section 5: Nonclinical pharmacology and toxicology Provide individual study reports, including pharmacology, toxicology, ADME studies. Effects related to the therapeutic indication, such as the pharmacodynamic ED50 in dose- ranging studies and the mechanism of action Interactions with other drugs (or cross-reference the location of the information in any of the above subsection) Slide 15: Section 6: Human Pharmacokinetics and bioavailability Includes data from Phase I safety and tolerance studies in healthy volunteers. Element in the section tabulated summary of studies showing all in vivo biopharmaceutics studies performed Summary of analytical method used in in vivo biopharmaceutic study Pilot or background studies Bioavailability or bioequivalence studies Pharmacokinetic studies In vitro studies Section 7: Microbiology Includes data for anti infective drug products. requires the following technical information and data:- A complete description of the biochemical basis of the drug action on microbial physiology The drugs antimicrobial spectrum Describe any known mechanism of resistance to the drug and provide information/data of any known epidemiologic studies demonstrating prevalence to resistance factor Clinical microbiology laboratory methods Slide 16: Section 8: Clinical data Includes. Background or overview of clinical investigations Clinical pharmacology Controlled clinical trials Uncontrolled clinical trials Other studies and information Integrated summary of effectiveness data Integrated summary of safety information Drug abuse and overdose information Integrated summary of benefits and risks of drug Slide 17: Section 9: Safety data Statements in draft labeling Contraindications Warnings Precautions Adverse events Section 10: Statistical data All controlled clinical trial reports Integrated efficacy and safety summaries Integrated summary of risks and benefits Slide 18: Section 11: Case report tabulation include complete tabulation for each patient from every adequately are well controlled phase II and Phase III efficacy, clinical pharmacology study. It also tabulation of safety data from all clinical studies. Section 12: Case report forms include the complete CRF for each patient who died during a clinical study or adverse event, regardless of whether the AE is considered to be related to the study drug, even if the patient was receiving a placebo or comparative drug. Slide 19: 13: Patent information (Form 3542a) 14: Patent certification 15: Establishment description (for biologics only) 16: Debarment certification 17: Field copy certification 18: User fee cover sheet (Form FDA-3397) FDA charges a fee for the review of an original NDA, and certain other NDA submissions. These fees vary according to their type and the need to review clinical data. Slide 20: 19: Financial disclosure (Form FDA 3454, form FDA-3455) 20: Other/pediatric use The FDA requires drug sponsors to submit multiple copies of the NDA The archival copy The review copy The field copy Slide 21: The Archival Copy The Archival Copy Contains all sections of the NDA, including The cover letter, Form FDA-356h (Application to Market a New Drug, Biologic, or an Antibiotic for Human Use), The administrative sections, Comprehensive NDA index, and All technical sections. It must contain four copies of the Labeling section. It must contain three additional copies of the CMC and Methods Validation Package in a separate binder. The archival copy is the only copy that contains the Case Report Tabulation and Case Report Forms. The Archival Copy The Review Copy : The Review Copy The Review Copy Intended for reviewers in the corresponding technical disciplines. In addition to the appropriate technical section, each review copy also includes The cover letter, Form FDA-356h, The administrative sections, Comprehensive NDA index Individual table of contents, The Labeling section, and The Application Summary. The Field Copy : The Field Copy Required since 1993 for use by FDA inspectors during pre approval facilities inspections. It includes the Cover letter and Form FDA-356h, The administrative sections, The comprehensive NDA index Individual table of contents, The Labeling section, The Application Summary, and CMC and Methods Validation Package. The NDA in CTD Format : The NDA in CTD Format ICH has developed a Common Technical Document to streamline regulatory submissions in Europe, U.S. and Japan. CTD is an information format that contains clinical, nonclinical, and manufacturing technical data. The CTD format features well-defined modules, with a highly specific structure and numbering of sections within the modules. It makes a clear distinction between subjective information sections and objective information sections. NDA Review Process : NDA Review Process TIMING Within 45 days after receipt of the NDA, the reviewing division will meet, and determine if the application is fileable. If the application is to be filed, then a review plan is established for that NDA, its review priority depending on the importance of the drug If not fileable, a refuse to file (RTF) letter is sent to the sponsor. NDA Review Process : NDA Review Process Slide 32: Advisory committee During the course of few NDA reviews, issues or controversies may arise, and the FDA may call for a consultation with one of its advisory commitees These are comprised of subject matter experts in various medical and scientific fields. FDA Action letter The action letter can be in three forms: Approval, approvable and not approvable Approval letter- allows product to be marketed in US after approval date Approvable letter- Is sent to an applicant if the FDA believes the application can be approved, if the sponsor submits additional information or agrees to certain conditions. Not approvable- the application did not meet FDA requirements and the letter will describe the deficiencies in the NDA ANDA : ANDA “ANDA” is the abbreviation for Abbreviated New Drug Application Generic drug applications are termed “abbreviated” in that they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness ANDA is provided for the marketing of generic drug products after all forms of exclusivity have expired for the RLD( innovator drug) ANDAs are files under the FD&C Act section 505(j) Generic drug products must be bioequivalent to the innovator product. The API, dosage form, dose strength, labeling, route of administration and conditions must be the same. Goal of ANDA : Goal of ANDA To reduce the price of the drug. To reduce the time for development. Increase the bioavailability of the drug in comparison to references list drug. Basis for an ANDA submissionPatent certification and exclusivity : Basis for an ANDA submissionPatent certification and exclusivity Sponsors of an ANDA must file a patent certification under one of the following paragraphs: That no patent information on the drug product that is the subject of the ANDA has been submitted to the FDA That such patents has expired The date on which such patent expires That such patent is invalid or will not be infringed by the manufacture, use or sale of the drug product from which the ANDA is submitted Slide 36: If the ANDA applicant files the paragraph IV certification, the applicant must also notify the innovator within 20dys of filing of an ANDA, and the innovator has 45 days to take action upon receiving the notification. The FDA may hold the approval upto 30 months, depending on the outcome of the litigation, if any. Labeling Differences between the applicants proposed labeling, and labeling approved for the reference listed drug, may include differences in expiration date, formulation, bioavailability or pharmacokinetics, labeling revisions made to comply with current FDA labeling guidelines All labeling for a generic drug product must be provided in SPL formatting, and in compliance with the Physicians Labeling Rule Bioavailability/ Bioequivalence : Bioavailability/ Bioequivalence Bioequivalence is the absence of a significant difference in the rate and extent of drug available at the site of action after dosing of a test product, compared to a reference product. Recommendations of study designs and data evaluation for bioequivalence study are listed in regulatory guidance. Bioequivalence is achieved when the 90% confidence interval (CI) for the ratio of Cmax and AUC of the test product over the reference product on log transformed data is within 80-125% ANDA/AADA Review Process : ANDA/AADA Review Process Post-Approval Activities For NDA and ANDA : Post-Approval Activities For NDA and ANDA Annual reports: Sponsors of NDA or ANDA must submit an annual report each year, within 60 days of the anniversary date of US Approval of the application, to the FDA division responsible for reviewing the application. The report is required to contain in the order listed: Form FDA 2252( Tramittal of periodic reports for drugs for human use) Summary Distribution data Labelling CMC changes Non clinical laboratory studies Clinical data Status reports of post-marketing study commitments Status of other post-marketing studies Log of outstanding regulatory business (optional) Other considerations for NDA and ANDA : Other considerations for NDA and ANDA Supplemental Applications Establishment registration and drug listing requirements for foreign establishments. Pre-Approval Inspection The purpose of PAI is to verify the authenticity of data submitted in the applications, and to evaluate the cGMP compliance of the applicant. Slide 43: 43 THANK YOU You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.
product registration and drug approval process in united states keerthi09 Download Post to : URL : Related Presentations : Share Add to Flag Embed Email Send to Blogs and Networks Add to Channel Uploaded from authorPOINT lite Insert YouTube videos in PowerPont slides with aS Desktop Copy embed code: (To copy code, click on the text box) Embed: URL: Thumbnail: WordPress Embed Customize Embed The presentation is successfully added In Your Favorites. Views: 399 Category: Science & Tech.. License: All Rights Reserved Like it (1) Dislike it (0) Added: August 17, 2010 This Presentation is Public Favorites: 2 Presentation Description NDA, ANDA, application and review process Comments Posting comment... By: xyz4 (15 month(s) ago) dear madam, very nice presentation. I require this presentation for teaching of m pharm students. kindly send it. my e. mail is: lalit_lata@hotmail.com Saving..... Post Reply Close Saving..... Edit Comment Close By: Shiv43 (15 month(s) ago) Dear Madam, I require this presentation for my acadamic purposes. kindly arrnge to send me the same and I will be highly greatful. Saving..... Post Reply Close Saving..... Edit Comment Close By: kdkiranbheda (19 month(s) ago) plz sir send me this ppt this will help me in my study of m.pharm at kiranbheda@yahoo.com Saving..... Post Reply Close Saving..... Edit Comment Close Premium member Presentation Transcript Product Registration and Drug Approval Process in United States : Product Registration and Drug Approval Process in United States keerthi priya Slide 2: 2 overview Back ground for product registration in the united states The New Drug Application (NDA) and review process Generic drug product registration and review process (ANDA) Post-Approval activities for NDA and ANDA Other considerations for NDA and ANDA Pre-Approval inspection Background for product registration in the United States : Background for product registration in the United States All new drug products must be registered and approved by the regulatory agency governing the intended market before the products can be introduced into the market. The registration process is to ensure the quality, safety, and efficacy of drug products. The requirements for the development and registration of new drug products in the United states are defined in the Federal Food Drug and Cosmetic Act (FD&C Act) and the regulations promulgated by the FDA. Introduction : Introduction The new drug application (N D A) is a critical component in the drug approval process. The NDA contains Clinical and nonclinical test data and analyses, Drug chemistry information, and Descriptions of manufacturing procedures. An NDA consists of thousands of pages of information to be reviewed by FDA teams composed of highly qualified individuals with expertise in their respective technical fields. Introduction : Introduction NDAs and ANDAs are submitted to FDA FDA has complex organisation for review and approval of NDAs and ANDAs. Review and approval are conducted by CDER Which reports directly to the office of commissioner of FDA Within CDER there are number of offices organized under the office of center director. Slide 8: 8 New Drug Application (NDA) Classifications New molecular entity New salt of previously approved drug New formulation of previously approved drug (not a new salt OR a new molecular entity) New combination of two or more drugs Already Marketed Drug Product – Duplication (i.e., new manufacturer) New Indication (claim) for Already Marketed Drug ( includes switch in marketing status from prescription to OTC) Already Marketed Drug Product – No previously Approved NDA Slide 9: six different teams are responsible for reviewing an NDA. The teams are organized by technical reviewing responsibilities: Clinical Pharmacology/toxicology, Chemistry ,Statistics, Biopharmaceutical and Microbiology. The FDA has established guidelines for formatting, assembling, and submitting the NDA. Failure to follow these guidelines can result in deficiencies that could Delay review, Require an amended application, or Result in a refusal to File. In 1997 the FDA’s Center for Drug Evaluation and Research (CDER) published guidelines that allow sponsors to submit NDAs electronically instead of on paper NDA starts with FDA form 356h which provides listing of 20 sections. The Form 356h is completed and signed by the sponsor or the sponsors authorized US agent, who resides or maintains a business site in the United states. Format and content of NDA : Format and content of NDA Index Summary Chemistry, Manufacturing and Control Samples, Methods Validation Package and Labeling Nonclinical Pharmacology and Toxicology 6. Human Pharmacokinetics and Bioavailability 7. Microbiology ( for anti-microbial drugs only) 8. Clinical Data 9. Safety Update report ( typically submitted 120 days after the NDA’s submission ) 10. Statistical 11. Case Report Tabulations Slide 11: 11.Case Report Tabulations 12.Case Report Forms 13. Patent Information 14. Patent Certification 15. Establishment description 16. Debarment certification 17. Field copy certification 18. User fee cover sheet 19. Financial information 20. Other NDA CONTENTS : NDA CONTENTS Section 1: Overall NDA index:- It Provides a guide through the entire application for the FDA reviewers. The index must clearly describe the contents and location of each section by volume and page number. Section 2: Labeling It must include all draft labeling that is intended for use on the product container, cartons or packages, including the proposed package insert. Slide 13: Section 3: Application summary The application summary is an abbreviated version of the entire application. This overview is one of the few elements of the application that all reviewers receive, and it should give them a clear idea of the drug and its application. The summary usually comprises 50 to 200 pages Application Summary The draft product labeling include the following sections 1. Description 2. Clinical Pharmacology 3. Indications and Usage 4. Contraindications 5. Warnings 6. Precautions 7. Adverse Reactions 8. Drug Abuse and Dependence 9. Overdosage 10. Dosage and Administration 11. How Supplied (primary and secondary packages) Slide 14: Section 4: Chemistry, manufacturing and controls Chemistry, Manufacturing, and Controls (CMC) The first technical section of the NDA It includes information on The composition, Manufacturing, and Specifications of the drug substance and the drug product. The three main elements are Chemistry, manufacturing and controls information, Samples, Method validation, package. Section 5: Nonclinical pharmacology and toxicology Provide individual study reports, including pharmacology, toxicology, ADME studies. Effects related to the therapeutic indication, such as the pharmacodynamic ED50 in dose- ranging studies and the mechanism of action Interactions with other drugs (or cross-reference the location of the information in any of the above subsection) Slide 15: Section 6: Human Pharmacokinetics and bioavailability Includes data from Phase I safety and tolerance studies in healthy volunteers. Element in the section tabulated summary of studies showing all in vivo biopharmaceutics studies performed Summary of analytical method used in in vivo biopharmaceutic study Pilot or background studies Bioavailability or bioequivalence studies Pharmacokinetic studies In vitro studies Section 7: Microbiology Includes data for anti infective drug products. requires the following technical information and data:- A complete description of the biochemical basis of the drug action on microbial physiology The drugs antimicrobial spectrum Describe any known mechanism of resistance to the drug and provide information/data of any known epidemiologic studies demonstrating prevalence to resistance factor Clinical microbiology laboratory methods Slide 16: Section 8: Clinical data Includes. Background or overview of clinical investigations Clinical pharmacology Controlled clinical trials Uncontrolled clinical trials Other studies and information Integrated summary of effectiveness data Integrated summary of safety information Drug abuse and overdose information Integrated summary of benefits and risks of drug Slide 17: Section 9: Safety data Statements in draft labeling Contraindications Warnings Precautions Adverse events Section 10: Statistical data All controlled clinical trial reports Integrated efficacy and safety summaries Integrated summary of risks and benefits Slide 18: Section 11: Case report tabulation include complete tabulation for each patient from every adequately are well controlled phase II and Phase III efficacy, clinical pharmacology study. It also tabulation of safety data from all clinical studies. Section 12: Case report forms include the complete CRF for each patient who died during a clinical study or adverse event, regardless of whether the AE is considered to be related to the study drug, even if the patient was receiving a placebo or comparative drug. Slide 19: 13: Patent information (Form 3542a) 14: Patent certification 15: Establishment description (for biologics only) 16: Debarment certification 17: Field copy certification 18: User fee cover sheet (Form FDA-3397) FDA charges a fee for the review of an original NDA, and certain other NDA submissions. These fees vary according to their type and the need to review clinical data. Slide 20: 19: Financial disclosure (Form FDA 3454, form FDA-3455) 20: Other/pediatric use The FDA requires drug sponsors to submit multiple copies of the NDA The archival copy The review copy The field copy Slide 21: The Archival Copy The Archival Copy Contains all sections of the NDA, including The cover letter, Form FDA-356h (Application to Market a New Drug, Biologic, or an Antibiotic for Human Use), The administrative sections, Comprehensive NDA index, and All technical sections. It must contain four copies of the Labeling section. It must contain three additional copies of the CMC and Methods Validation Package in a separate binder. The archival copy is the only copy that contains the Case Report Tabulation and Case Report Forms. The Archival Copy The Review Copy : The Review Copy The Review Copy Intended for reviewers in the corresponding technical disciplines. In addition to the appropriate technical section, each review copy also includes The cover letter, Form FDA-356h, The administrative sections, Comprehensive NDA index Individual table of contents, The Labeling section, and The Application Summary. The Field Copy : The Field Copy Required since 1993 for use by FDA inspectors during pre approval facilities inspections. It includes the Cover letter and Form FDA-356h, The administrative sections, The comprehensive NDA index Individual table of contents, The Labeling section, The Application Summary, and CMC and Methods Validation Package. The NDA in CTD Format : The NDA in CTD Format ICH has developed a Common Technical Document to streamline regulatory submissions in Europe, U.S. and Japan. CTD is an information format that contains clinical, nonclinical, and manufacturing technical data. The CTD format features well-defined modules, with a highly specific structure and numbering of sections within the modules. It makes a clear distinction between subjective information sections and objective information sections. NDA Review Process : NDA Review Process TIMING Within 45 days after receipt of the NDA, the reviewing division will meet, and determine if the application is fileable. If the application is to be filed, then a review plan is established for that NDA, its review priority depending on the importance of the drug If not fileable, a refuse to file (RTF) letter is sent to the sponsor. NDA Review Process : NDA Review Process Slide 32: Advisory committee During the course of few NDA reviews, issues or controversies may arise, and the FDA may call for a consultation with one of its advisory commitees These are comprised of subject matter experts in various medical and scientific fields. FDA Action letter The action letter can be in three forms: Approval, approvable and not approvable Approval letter- allows product to be marketed in US after approval date Approvable letter- Is sent to an applicant if the FDA believes the application can be approved, if the sponsor submits additional information or agrees to certain conditions. Not approvable- the application did not meet FDA requirements and the letter will describe the deficiencies in the NDA ANDA : ANDA “ANDA” is the abbreviation for Abbreviated New Drug Application Generic drug applications are termed “abbreviated” in that they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness ANDA is provided for the marketing of generic drug products after all forms of exclusivity have expired for the RLD( innovator drug) ANDAs are files under the FD&C Act section 505(j) Generic drug products must be bioequivalent to the innovator product. The API, dosage form, dose strength, labeling, route of administration and conditions must be the same. Goal of ANDA : Goal of ANDA To reduce the price of the drug. To reduce the time for development. Increase the bioavailability of the drug in comparison to references list drug. Basis for an ANDA submissionPatent certification and exclusivity : Basis for an ANDA submissionPatent certification and exclusivity Sponsors of an ANDA must file a patent certification under one of the following paragraphs: That no patent information on the drug product that is the subject of the ANDA has been submitted to the FDA That such patents has expired The date on which such patent expires That such patent is invalid or will not be infringed by the manufacture, use or sale of the drug product from which the ANDA is submitted Slide 36: If the ANDA applicant files the paragraph IV certification, the applicant must also notify the innovator within 20dys of filing of an ANDA, and the innovator has 45 days to take action upon receiving the notification. The FDA may hold the approval upto 30 months, depending on the outcome of the litigation, if any. Labeling Differences between the applicants proposed labeling, and labeling approved for the reference listed drug, may include differences in expiration date, formulation, bioavailability or pharmacokinetics, labeling revisions made to comply with current FDA labeling guidelines All labeling for a generic drug product must be provided in SPL formatting, and in compliance with the Physicians Labeling Rule Bioavailability/ Bioequivalence : Bioavailability/ Bioequivalence Bioequivalence is the absence of a significant difference in the rate and extent of drug available at the site of action after dosing of a test product, compared to a reference product. Recommendations of study designs and data evaluation for bioequivalence study are listed in regulatory guidance. Bioequivalence is achieved when the 90% confidence interval (CI) for the ratio of Cmax and AUC of the test product over the reference product on log transformed data is within 80-125% ANDA/AADA Review Process : ANDA/AADA Review Process Post-Approval Activities For NDA and ANDA : Post-Approval Activities For NDA and ANDA Annual reports: Sponsors of NDA or ANDA must submit an annual report each year, within 60 days of the anniversary date of US Approval of the application, to the FDA division responsible for reviewing the application. The report is required to contain in the order listed: Form FDA 2252( Tramittal of periodic reports for drugs for human use) Summary Distribution data Labelling CMC changes Non clinical laboratory studies Clinical data Status reports of post-marketing study commitments Status of other post-marketing studies Log of outstanding regulatory business (optional) Other considerations for NDA and ANDA : Other considerations for NDA and ANDA Supplemental Applications Establishment registration and drug listing requirements for foreign establishments. Pre-Approval Inspection The purpose of PAI is to verify the authenticity of data submitted in the applications, and to evaluate the cGMP compliance of the applicant. Slide 43: 43 THANK YOU