This document provides an overview of Vineeth Kumar Ekbote's lab presentation on new drug applications (NDAs). The presentation covers what an NDA is, the goals and process of an NDA, the forms and contents required in an NDA submission, guidance documents for NDAs, and how NDAs are reviewed and approved by the FDA. The presentation also describes the various sections required in an NDA, including the application summary, chemistry and manufacturing controls, clinical data, and labeling.
Abbreviated New Drug Application [ANDA]Sagar Savale
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's CDER, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
The NDA application is the vehicle through which drug sponsors, such as biotech and pharmaceutical companies, formally propose that the FDA approve a new pharmaceutical for sale and marketing
Abbreviated New Drug Application [ANDA]Sagar Savale
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's CDER, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
The NDA application is the vehicle through which drug sponsors, such as biotech and pharmaceutical companies, formally propose that the FDA approve a new pharmaceutical for sale and marketing
For better understanding of students. This will give you a detailed explanation of IND APPLICATION. Contact me through comment section if you need any assistance in understating this topic.
ICH: Introduction, objectives & guidelines: A brief insight.RxVichuZ
This is my 44th powerpoint........deals with ICH guidelines.....
Deals with brief introduction, precise objectives, organization(in short) & guidelines (in precise), based on SAFETY, EFFICACY, QUALITY & MULTIDISCIPLINARY guidelines.
Happy reading!!
:)
A brief presentation on the Code of Federal Regulations
Covers the following aspects -
- What is CFR?
-History of CFR
- CFR Title 21
- CFR in modern times.
- Research tools in CFR
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
An innovator or branded drug is the first drugs created containing its specific active ingredient to receive approval for use.
A generic drug is made of the same active ingredient as its innovator drug.
Abbreviated New Drug Application (ANDA)RaghaviPillai
This presentation gives a complete brief idea of how FDA regulates the marketing of Generic drugs. An application has to be filled out for the approval of marketing generic drugs. ANDA form has to be filled and submitted for this purpose.
DRUG MASTER FILE
Presented by :
RUSHIKESH D MENDHE
Roll no - 511
Mpharm Ist Year
(Department of Pharmaceutics)
Content : :
INTRODUCTION
TYPES OF DMF
DMF FORMAT & ASSEMBLY
DELIVERY OF DMF TO FDA
SUBMISSION OF DMF
THE MECHANISM OF A DRUG MASTER FILE
CTD & ELECTRONIC DMFS
UPDATES TO DMF
CLOSURE OF A DRUG MASTER FILE
APPLICATION OF DMF
REFERENCE
INTRODUCTION :
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.
This guideline does not impose mandatory requirements.
Objectives :
Main Objective of the DMF is to support regulatory requirements
To prove the quality, safety and efficacy of the medicinal product
TYPES OF DMF :
DMF FORMAT & ASSEMBLY :
The DMF is submitted as Original and Duplicate jackets, collated, assembled, paginated, and jacketed, using covers obtained from the government printing office and a respecifically provided for the DMFs
Multiple volumes are numbered, and the paper must be standard paper size
Paper length should not be less than 10 inches nor more than 12 inches.
Each volume of a DMF should be not more than 2 inches thick
DELIVERY OF DMF TO FDA :
DMF should be submitted at following address :
Food and Drug Administration Center for Drug Evaluation and Research Central Document Room 5901 – B Ammendale Road Beltsville, MARYLAND 20705-1266 USA
SUBMISSION OF DMF :
The DMF must be submitted in two copies, one with a blue cover and one with a red cover.
Each page of each copy of the DMF should be dated and consecutively numbered.
Each DMF submission should contain :
• A Transmittal letter
• Administrative information about the submission
• Other specific information
A. Transmittal Letter :
i) Original Submissions :
• Identification of submission: Original, the type of DMF as classified in Section III, and its subject.
• Identification of the applications, if known, that the DMF is intended to support, including the name and address of each sponsor, applicant, or holder, and all relevant document numbers.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
ii) Ammendments :
• Identification of submission: Amendment, the DMF number, type of DMF, and the subject of the amendment.
• A description of the purpose of submission, e.g., update, revised formula, or revised process.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
B. Administrative information about the submission:
The presentation aims at a students focussed perspective of Abbreviated New Drug Application filing with premier regulatory body like USFDA, the eCTD is followed worldwide for drug submission aimed for gaining particular market approvals.When submitted with FDA it is evaluated by CDER. eCTD is further a mandatory submission for ANDAs with FDA and for NDAs with EU and Japan.
For better understanding of students. This will give you a detailed explanation of IND APPLICATION. Contact me through comment section if you need any assistance in understating this topic.
ICH: Introduction, objectives & guidelines: A brief insight.RxVichuZ
This is my 44th powerpoint........deals with ICH guidelines.....
Deals with brief introduction, precise objectives, organization(in short) & guidelines (in precise), based on SAFETY, EFFICACY, QUALITY & MULTIDISCIPLINARY guidelines.
Happy reading!!
:)
A brief presentation on the Code of Federal Regulations
Covers the following aspects -
- What is CFR?
-History of CFR
- CFR Title 21
- CFR in modern times.
- Research tools in CFR
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
An innovator or branded drug is the first drugs created containing its specific active ingredient to receive approval for use.
A generic drug is made of the same active ingredient as its innovator drug.
Abbreviated New Drug Application (ANDA)RaghaviPillai
This presentation gives a complete brief idea of how FDA regulates the marketing of Generic drugs. An application has to be filled out for the approval of marketing generic drugs. ANDA form has to be filled and submitted for this purpose.
DRUG MASTER FILE
Presented by :
RUSHIKESH D MENDHE
Roll no - 511
Mpharm Ist Year
(Department of Pharmaceutics)
Content : :
INTRODUCTION
TYPES OF DMF
DMF FORMAT & ASSEMBLY
DELIVERY OF DMF TO FDA
SUBMISSION OF DMF
THE MECHANISM OF A DRUG MASTER FILE
CTD & ELECTRONIC DMFS
UPDATES TO DMF
CLOSURE OF A DRUG MASTER FILE
APPLICATION OF DMF
REFERENCE
INTRODUCTION :
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.
This guideline does not impose mandatory requirements.
Objectives :
Main Objective of the DMF is to support regulatory requirements
To prove the quality, safety and efficacy of the medicinal product
TYPES OF DMF :
DMF FORMAT & ASSEMBLY :
The DMF is submitted as Original and Duplicate jackets, collated, assembled, paginated, and jacketed, using covers obtained from the government printing office and a respecifically provided for the DMFs
Multiple volumes are numbered, and the paper must be standard paper size
Paper length should not be less than 10 inches nor more than 12 inches.
Each volume of a DMF should be not more than 2 inches thick
DELIVERY OF DMF TO FDA :
DMF should be submitted at following address :
Food and Drug Administration Center for Drug Evaluation and Research Central Document Room 5901 – B Ammendale Road Beltsville, MARYLAND 20705-1266 USA
SUBMISSION OF DMF :
The DMF must be submitted in two copies, one with a blue cover and one with a red cover.
Each page of each copy of the DMF should be dated and consecutively numbered.
Each DMF submission should contain :
• A Transmittal letter
• Administrative information about the submission
• Other specific information
A. Transmittal Letter :
i) Original Submissions :
• Identification of submission: Original, the type of DMF as classified in Section III, and its subject.
• Identification of the applications, if known, that the DMF is intended to support, including the name and address of each sponsor, applicant, or holder, and all relevant document numbers.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
ii) Ammendments :
• Identification of submission: Amendment, the DMF number, type of DMF, and the subject of the amendment.
• A description of the purpose of submission, e.g., update, revised formula, or revised process.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
B. Administrative information about the submission:
The presentation aims at a students focussed perspective of Abbreviated New Drug Application filing with premier regulatory body like USFDA, the eCTD is followed worldwide for drug submission aimed for gaining particular market approvals.When submitted with FDA it is evaluated by CDER. eCTD is further a mandatory submission for ANDAs with FDA and for NDAs with EU and Japan.
This presentation explains concepts of Patents and Market Exclusivity. This presentation is compiled from publicly available material on the world wide web.
A small description of what is pharmaceutical waste, hospital and otherwise, some regulations and some of the practices used to manage such waste.
This presentation was done just under 10 minutes which was the time limit.
A presentation outlining the various processes a chemical compound undergoes (thorough & rigorous screening procedures) before it is finally introduced into the drug market
USFDA Approval Process For Drug Products & Biological Product i.e NDA Vs. BLA
Comparison of NDA and BLA application process in USA. IND, NDA, ANDA & BLA dossier submission procedure.
Pharmaceutical Waste Treatment and Disposal Practicesrekhac86
Treatment of pharmaceutical waste is very important because improper disposal may also have an adverse effect on land values, create public nuisances, otherwise; the failure or inability to salvage and reuse such materials economically results in the unnecessary waste and depletion of natural resources
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.
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 NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA.
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 NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA.
Investigational new drug application must be submitted after discovering a new drug and before beginning of clinical trials. Here given a brief note on the topic.The topics included are types of IND, criteria for application, Information in IND application, resources for IND application, laws.regulations, policies and procedures, IND forms and instructions, IND content requirements and review of IND
Students, digital devices and success - Andreas Schleicher - 27 May 2024..pptxEduSkills OECD
Andreas Schleicher presents at the OECD webinar ‘Digital devices in schools: detrimental distraction or secret to success?’ on 27 May 2024. The presentation was based on findings from PISA 2022 results and the webinar helped launch the PISA in Focus ‘Managing screen time: How to protect and equip students against distraction’ https://www.oecd-ilibrary.org/education/managing-screen-time_7c225af4-en and the OECD Education Policy Perspective ‘Students, digital devices and success’ can be found here - https://oe.cd/il/5yV
Embracing GenAI - A Strategic ImperativePeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
Unit 8 - Information and Communication Technology (Paper I).pdfThiyagu K
This slides describes the basic concepts of ICT, basics of Email, Emerging Technology and Digital Initiatives in Education. This presentations aligns with the UGC Paper I syllabus.
This presentation provides an introduction to quantitative trait loci (QTL) analysis and marker-assisted selection (MAS) in plant breeding. The presentation begins by explaining the type of quantitative traits. The process of QTL analysis, including the use of molecular genetic markers and statistical methods, is discussed. Practical examples demonstrating the power of MAS are provided, such as its use in improving crop traits in plant breeding programs. Overall, this presentation offers a comprehensive overview of these important genomics-based approaches that are transforming modern agriculture.
How to Create Map Views in the Odoo 17 ERPCeline George
The map views are useful for providing a geographical representation of data. They allow users to visualize and analyze the data in a more intuitive manner.
Power-sharing Class 10 is a vital aspect of democratic governance. It refers to the distribution of power among different organs of government, levels of government, and social groups. This ensures that no single entity can control all aspects of governance, promoting stability and unity in a diverse society.
For more information, visit-www.vavaclasses.com
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
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(1) Natural Ecosystem
(2) Artificial Ecosystem
component of ecosystem
Biotic Components
Abiotic Components
Producers
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Decomposers
Functions of Ecosystem
Types of Biodiversity
Genetic Biodiversity
Species Biodiversity
Ecological Biodiversity
Importance of Biodiversity
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Green House Effect
The Indian economy is classified into different sectors to simplify the analysis and understanding of economic activities. For Class 10, it's essential to grasp the sectors of the Indian economy, understand their characteristics, and recognize their importance. This guide will provide detailed notes on the Sectors of the Indian Economy Class 10, using specific long-tail keywords to enhance comprehension.
For more information, visit-www.vavaclasses.com
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New drug application
1. LAB PRESENTATION
NEW DRUG APPLICATION
Presented by
Vineeth Kumar Ekbote
M.Pharm. (Ist semester)
Dept. Of Pharmaceutical Technology (Formulations)
NIPER, S.A.S. Nagar, Punjab.
1
2. Flow of Presentation
• What is NDA
• Goals of NDA
• When will we go for NDA
• NDA Forms
• Contents of NDA
• Guidance document for submission of NDA
• Submission of NDA
• Review & Approval of NDA
2
3. New Drug Application
Since 1938, every new drug has been the subject of an
approved NDA before U.S. commercialization
The NDA application is the vehicle through which drug sponsors
formally propose that the FDA approve a new pharmaceutical
for sale and marketing in the U.S.
The data gathered during the animal studies and human clinical
trials of an Investigational New Drug (IND) become part of the
NDA
3
4. Goals of NDA
• Safety and Effectiveness of a new drug in its proposed use(s)
• Whether the drug's proposed labeling (package insert) is appropriate
• 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 benefits of the drug outweigh the risks
4
5. NDA
Pre Clinical
Clinical studies Filling
studies
I Phase-I Phase-II Phase-III
Animal N
testing of a D
New drug Safety
F
i Effective R
l ness E Approval
l
V
i
More Info. I
n
E
Short term g
W Disapproval
Long term
5
6. NDA Forms & Electronic Submissions
• Form FDA- 356h. Application to market a New drug, biologic or an antibiotic
drug for human use
• Form FDA- 3397. User fee cover sheet
• Form FDA- 3331. New drug application field report
• Guidance documents for electronic submissions
6
7. • Submit information regarding distributed Drug products an articles to
FDA, Which contains
(i) Any incident that causes the drug product or it’s labeling to be mistaken
for another article
(ii) Any bacteriological content/ chem. and physical detritioration/ failure to
meet the specification
7
8. • The NDA may have as many as 20 different sections in addition to the Form
FDA-356h itself
• The specific contents of the NDA will depend on the Nature of the drug product
and the information available at the time of submission the application
• Form FDA-356h serves as Checklist as well as Certification that, the sponsor
agrees to comply with a range of legal and regulatory requirements
8
10. Contd…
NDA Section 6 Human pharmacokinetics and bioavailability
NDA Section 7 Clinical microbiology
NDA Section 8 Clinical data
NDA Section 9 Safety update reports
NDA Section 10 Statistics
10
11. Contd…
NDA Section 11 Case report tabulations
NDA Section 12 Case Report Forms (CRFs)
NDA Section 13 Patent information
NDA Section 14 Patent certification
NDA Section 15 Establishment description
11
12. Contd…
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 Other
12
13. Contd…
NDA Section 3: Application Summary :
• This is an abbreviated version of the entire application
• It should give reviewers a clear idea of the drug and its
application
• The summary usually comprises 50 to 200 pages
NDA Section 4: Chemistry, Manufacturing, andControls
(CMC) :
• The first technical section of the NDA It includes information
• The three main elements are
Chemistry, manufacturing and controls information
Samples (Submit only upon FDA’s request)
Methods validation package
13
14. Contd…
CMC – Drug Substance
• The description
• The physical and chemical characteristics
• Structural elucidation
• Drug substance manufacturing methods
• Drug substance analytical controls
• Drug substance stability
14
15. Contd…
CMC – Drug Product
• List of all components, quantities
• Drug product manufacturing methods
• Drug product packaging
• The drug product stability
15
16. Contd…
NDA Section 7: Clinical Microbiology:
• Required for anti infective drug products
• Biochemical basis of the drug’s action on microbial
physiology
• The drug’s antimicrobial spectrum
• Mechanisms of resistance to the drug
• Clinical microbiology laboratory methods
16
17. Contd…
NDA Section 11: Case Report Tabulations:
• Complete tabulations for each patient from Phase II and Phase
III efficacy study
• Phase I clinical pharmacology study
• Safety data from all clinical studies
NDA Section 12: Case Report Forms (CRFs):
• CRF for each patient who died during a clinical study
• Patients who were dropped from the study
17
18. Guidance Documents for NDAs
• These documents are prepared for FDA review staff and applicants/sponsors
to provide guidelines to the processing, content, and evaluation/approval of
applications
• CDER gives guidance documents to help prepare NDAs
• CDER - Centre for Drug Evaluation and Research
Drug Registraion & Licensing System
ICSR-Individual Case Safety system Reporting
18
19. Guidance Documents for NDAs
Contd…
• Bioavailability and bioequivalence studies for Orally administered drug products-
General considerations
• Formatting, assembling and sumitting new drug and antibiotic application
• Format and content of Chemistry, Manufacturing and Control section of an
application
• Format and content of Microbiology section of an application
• Format and content of Clinical and Statistical section of an application
• Container closure system for packing human drugs and biologics
19
20. Guidance Documents for NDAs
Contd…
• Submitting documentation for the Stability of human drugs and biologics
• Format and content of human pharmacokinetics and bioavailability section of an
application
• Providing clinical evidence of effectiveness for human drug and biological
products
• NDAs- Impurities in drug substanses
• Drug Master Files (DMF)
• Required specifications for FDA’s IND, NDA and ANDA drug master file binders
• Refusal to file
20
21. Common Technical Document
• In 1997 the FDA’s CDER, Published guidelines that allow sponsors to
submit NDAs electronically instead of on paper
21
22. Specifications for FDA’s DMF binders
Polyethylene binders :
• Front- 248 X 292 mm
• Back- 248 X 305 mm
• Must be withstand at temp. of 150 degree C
• Ink colour must be BLACK
• FDA Form 2626 - Blue - NDA archival binder
• FDA Form 2675 - Red - IND archival binder
• FDA Form 3316 - Red - Drug master file binder
• FDA Form 3316a - Blue - Drug master file archival binder
22
23. Specifications for FDA’s DMF binders
Paper binder :
• Front 267 X 292 mm
• Back 267 X 305 mm
• Ink colour must be BLCK, Maroon colour binder ink must be WHITE
• FDA Form 2626a - Red - NDA Chemistry binder
• FDA Form 2626b - Yellow - NDA Pharmacology binder
• FDA Form 2626c - Orange - NDA Pharmacokinetic binder
• FDA Form 2626d - White - NDA Microbiology binder
• FDA Form 2626e - Tan - NDA Clinical data binder
• FDA Form 2626f - Green - NDA Statistics binder
• FDA Form 2626h - Maroon - NDA Field submission chemistry binder
• FDA Form 2675a - Green - IND Chemistry binder
• FDA Form 2675b - Orange - IND Microbiology binder
23
25. Archival Copy
• The cover letter
• Form FDA- 356h
• The Administrative sections
• Comprehensive NDA index
• Four copies of labeling section
• Three copies of CMC, Methods validation package
• Case report tabulations & Case report forms
25
26. • The cover letter
• Form FDA- 356h
• The Administrative section
• Comprehensive NDA- index
• The labeling section
• The applicantion summary
26
27. Applica
Applicant NDA -tion
Filable
No
Yes
Refuse to File
Letter is Issued Review by CDER
Medical Statistical
Biopharmaceutical Chemistry
Pharmacology Microbiology
Dis approval Approval
27
29. Fast Track Approval
Drugs For
• Serious diseases
• Fill an unmet medical need
• Must be requested by the drug company
.
• FDA- 60 Days-Review- Decision
29
30. Accelerated Approval
• In 1992 FDA instituted the Accelerated Approval regulation
• Based on a Surrogate endpoint, not on clinical outcome
• A surrogate endpoint is a marker- a laboratory measurement, or
physical sign - that is used in clinical trials as an indirect or substitute
measurement that represents a clinically meaningful outcome, such
as survival or symptom improvement
30
31. • A Priority Review designation is given to drugs that offer major advances
in treatment
• The goal for completing a Priority Review is six months
• It can given for Drugs use to Serious/ Nonserious diseases
• Standard Review is applied to a drug that offers a most, only minor
improvement over existing marketed therapies (Ten months for Approval)
31