This document discusses investigational new drug applications, the Orange Book, and 505(b)(2) applications. It provides an overview of the IND process including when an IND is needed, the content of an IND application, annual reporting requirements, and classifications of INDs. It also describes the Orange Book's listing of approved drugs and their therapeutic equivalence ratings. Finally, it gives a brief explanation of 505(b)(2) applications, including what products are allowed and examples of 505(b)(2) NDAs.
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.
Unit-III, Chapter 1. Registration of Indian Products in Overseas Market.Audumbar Mali
Unit-III, Chapter 1. Registration of Indian Products in Overseas Market.
B. Pharm. Final Year, Sem-VIII, BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory),
As PCI Syllabus.
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]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.
Unit-III, Chapter 1. Registration of Indian Products in Overseas Market.Audumbar Mali
Unit-III, Chapter 1. Registration of Indian Products in Overseas Market.
B. Pharm. Final Year, Sem-VIII, BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory),
As PCI Syllabus.
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.
India has a long way to go and needs to quickly align with rest of the world by making changes to its regulations and GMP’s to bring it on par with current requirements not only because of the large EU export based industry but also because even Indians deserve good quality medicines.
ICH stability guidances provide guidance for new drug substances and drug products .CDER now wishes to apply these recommendations to ANDAs. Specific recommendations were given in FDA “Guidance for Industry: ANDAs: Stability Testing of Drug Substances and Products. Recently FDA issued “Guidance for Industry: ANDAs: Stability Testing of Drug Substances and Products: Questions and Answers.
Drug Regulations has prepared a presentation on ANDA stability requirements.
COMMON REGULATORY AFFAIRS JOB INTERVIEW QUESTIONS WITH ANSWERS-Updated in 2022!Pristyn Research Solutions
COMMON REGULATORY AFFAIRS
JOB INTERVIEW QUESTIONS WITH
ANSWERS By Pristyn Research-Updated 2022.
A quick Job interview short guide For Pharma and all
Life science jobseekers.
info.pristynresearch.com
www.pristynresearch.com
9028839789 | 8999717656
All Medical | Biotech |Micro |B.Sc., M.Sc.
PAN India DRA companies
list alphabetically
Abbreviated New Drug Application (ANDA) Submission:
Introduction
Basic Generic Drug Requirements
Goals of ANDA
Basis of ANDA Submission
ANDA Forms and Submission Requirements
ANDA Review Process
CTD Triangle
Electronic Submissions
Checklist for ANDA submission (Module 1 to Module 5)
Documentation relating to product development,sop's,cleaning methods,quality ...swrk
COMPLAINT HANDLING IN PHARMACEUTICAL COMPANIES,PRODUCT RECALL,RETENTION RECORDS, DISTRIBUTION RECORDS.prepared by s.susena,m.pharmacy pharmaceutical analysis&QA,ssj college of pharmacy
A Strategic Approach: GenAI in EducationPeter 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.
Operation “Blue Star” is the only event in the history of Independent India where the state went into war with its own people. Even after about 40 years it is not clear if it was culmination of states anger over people of the region, a political game of power or start of dictatorial chapter in the democratic setup.
The people of Punjab felt alienated from main stream due to denial of their just demands during a long democratic struggle since independence. As it happen all over the word, it led to militant struggle with great loss of lives of military, police and civilian personnel. Killing of Indira Gandhi and massacre of innocent Sikhs in Delhi and other India cities was also associated with this movement.
Synthetic Fiber Construction in lab .pptxPavel ( NSTU)
Synthetic fiber production is a fascinating and complex field that blends chemistry, engineering, and environmental science. By understanding these aspects, students can gain a comprehensive view of synthetic fiber production, its impact on society and the environment, and the potential for future innovations. Synthetic fibers play a crucial role in modern society, impacting various aspects of daily life, industry, and the environment. ynthetic fibers are integral to modern life, offering a range of benefits from cost-effectiveness and versatility to innovative applications and performance characteristics. While they pose environmental challenges, ongoing research and development aim to create more sustainable and eco-friendly alternatives. Understanding the importance of synthetic fibers helps in appreciating their role in the economy, industry, and daily life, while also emphasizing the need for sustainable practices and innovation.
Model Attribute Check Company Auto PropertyCeline George
In Odoo, the multi-company feature allows you to manage multiple companies within a single Odoo database instance. Each company can have its own configurations while still sharing common resources such as products, customers, and suppliers.
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.
Palestine last event orientationfvgnh .pptxRaedMohamed3
An EFL lesson about the current events in Palestine. It is intended to be for intermediate students who wish to increase their listening skills through a short lesson in power point.
Investigational new drug ,orange book,understanding on 505(b) (2) applications
1. INVESTIGATIONAL NEW DRUG ,
ORANGE BOOK,
UNDERSTANDING ON 505(b) (2)
APPLICATIONS
Prepared By: S.Susena( M. Pharm Sem-2)
I.P.R . Department
Guided by: Y.Malyadri
S. S. J. Pharmacy College
1
2. CONTENTS
INVESTIGATIONAL NEW DRUG (IND)
INTRODUCTION
PRE-IND MEETING
THE CONTENT AND FORMAT OF AN IND
APPLICATION
ORANGE BOOK
UNDERSTANDING ON 505(b) (2)
APPLICATIONS
CONCLUSION
REFERENCES
2
3. 3
New Drug Development Process.
Initial
Synthesis
Animal
Testing
I
N
D
A
P
P
L
I
C
A
T
I
O
N
PhaseI
PhaseII
PhaseIII
PhaseIV
Adverse
Reaction
Reporting
Surveys/
Sampling
Testing
Inspections
Range 1-3Yrs.
Avg:18 Mos.
FDATime
30 Day
Safety Review
Range 2-10Yrs.
Avg :5Yrs.
NDA
Submitted
NDA
Approved
Range 2 Mon –
7Yrs.Avg:24 Mos.
Average of Approximately 100 Months From Initial Synthesis to Approval of NDA
Treatment Use
Preclinical Clinical Development NDA Review Post-Marketing
4. Introduction
An Investigational New Drug Application (IND) is a
submission to the Food and Drug Administration
requesting permission to initiate a clinical study of
a new drug product.
The Federal Food, Drug, and Cosmetic Act requires
that all drugs have an approved marketing
application (NDA, BLA, ANDA) before they can be
shipped in interstate commerce.
5. The IND application allows a company to
initiate and conduct clinical studies of their
new drug product.
The IND application provides the FDA with
the data necessary to decide whether the
new drug and the proposed clinical trial
pose a reasonable risk to the human
subjects participating in the study.
6. When Do I Need an IND?
An IND is required any time you want to
conduct a clinical trial of an unapproved
drug
The Act further defines a new drug, in part,
as “any drug the composition of which is
such that such drug is not generally
recognized as safe and effective for use
under the conditions prescribed,
recommended, or suggested in the labeling
7. When You Don’t Need an IND?
An IND is not required to conduct a study if
the drug:
Is not intended for human subjects, but is
intended for in vivo testing or laboratory
research animals (non clinical studies)
Is an approved drug and the study is within its
approved indication for use.
7
8. Pre-IND Meeting
A meeting between the sponsor and
the FDA frequently is useful in
resolving questions and issues raised
during the preparation for an IND.
The FDA encourages such meetings
to the extent that
1.They aid in the solution of
scientific problems and
2. To the extent that the FDA has
available resources. 8
9. The Content and Format of an IND
Application
The content and format of an initial IND is laid out
in 21 CFR Part 312
Cover Sheet —312.23(a)(1)FDA Form 1571
Table of Contents —313.23(a)(2)
Introductory Statement and General
Investigational Plan —312.23(a)(3)
Investigator’s Brochure —312.23(a)(5)
Clinical Protocol —312.23(a)(6)
Chemistry Manufacturing and Controls
Information —312.23(a)(7) 9
10. Pharmacology and Toxicology Information —
312.23(a)(8)
Previous Human Experience —312.23 (a)(9)
Additional Information —312.23(a)(10)
Relevant Information —312.23(a)(11)
Other Important Information about the Format,
Content and Submission of an IND
The FDA Review of the IND
10
12. Additional Information —312.23(a)(10) :
This section is used to present information on special
topics.
Drug dependence and abuse potential.
Radioactive drugs.
Pediatric studies. Any plans the sponsor has for assessing
the safety and effectiveness of the drug in the pediatric
population.
Other information. Any other relevant information that
might aid in the evaluation of the proposed clinical
investigations.
12
14. Other Important Information about the
Format, Content and Submission of an IND :
For clinical studies that will be submitted as part of an NDA
or BLA, IND sponsors must collect financial disclosure
information from each investigator or sub investigator who
is directly involved in the treatment or evaluation of clinical
trial subjects.
The sponsor may also reference a drug master file (DMF) in
the IND application that contains important information
necessary to complete review of the IND.
Reports or journal articles in a foreign language must be
accompanied by a complete and accurate English
translation. Each IND submission must include a four-digit
serial number.
14
15. IND Annual Reports :
The IND regulations require IND sponsors to submit an
annual report that provides the FDA with a brief update on
the progress of all investigations included in the IND.
The annual report must contain the following information:
Individual study information ,Summary Information ,The
general investigational plan for the coming year.
If the investigator brochure was modified during the year, a
list of the changes along with a copy of the new brochure
A listing of any significant foreign marketing developments
with the drug, e.g., approval in another country or
withdrawal or suspension of marketing approval.
15
16. CLASSIFICATION of INDs
INDs can be classified on four dimensions:
Commercial / Noncommercial,
Standard / Emergency,
Paper / Electronic,
Original / 505(b)(2).
16
17. Orange book
Its official title is Approved Drug Products with
Therapeutic Equivalence Evaluations .
Commonly known as the Orange Book due to the
orange cover of the original print version, it is the Food
and Drug Administration's list of all drugs approved in
the United States as safe and effective.
In addition to listing all approved drugs, the Orange
Book is also the authoritative source of information on
the therapeutic equivalence of drug products.
17
18. THE GREEN BOOK:
the Green Book had some additional and advantageous
features. For example, it listed drugs for which “authorized
generics” were available, information which the Orange book
does not contain
THE BLUE BOOK:
The FDA publication Requirement of Laws and Regulations
Enforced by the U.S. Food and Drug Administration. It has
been discontinued as of October 2002. In its place there is a
Wealth Of Compliance Information on the FDA
18
19. The Orange Book consists of five main
sections:
an introduction, a “how to use” section,
the drug product lists,
appendices, and
a patent
exclusivity information addendum.
19
20. TE Codes
TE codes are divided into two categories, A and B
‘A’ Drugs are those which the FDA considers to be
therapeutically equivalent and, therefore, substitutable
where permitted by the prescriber. They are further
divided as follows:
‘B’ Drugs are those which the FDA considers NOT to be
therapeutically equivalent due to actual or potential
bioequivalence problems which have not been resolved. B-
rated drugs are not legally substitutable
20
21. CODE A product that FDA considers
AA: Products in conventional dosage form.
AB, AB1, AB2, AB3: Products meeting necessary bio-
equivalence requirements
AN: Solutions and powder for aerosolization
AO: Injectable oil solutions
AP: Injectable aqueous solutions and intra-venous non-
aqueous solutions
AT: Topical products
AB: actual or potential bioequivalence problems have
been resolved through adequate in vivo and/or in vitro
testing. 21
22. BC Extended-release dosage forms (capsules, injectables and
tablets)
BD Active ingredients and dosage forms with documented
bioequivalence problems
BE Delayed-release oral dosage forms
BN Products in aerosol-nebulizer drug delivery systems
BP Active ingredients and dosage forms with potential
bioequivalence problems
BR Suppositories or enemas that deliver drugs for systemic
absorption
BS Products having drug standard deficiencies
BT Topical products with bioequivalence issues
BX Drug products for which the data are insufficient to determine
therapeutic equivalence
22
23. UNDERSTANDING ON 505(b) (2)
APPLICATIONS
The 505(b)(2) New Drug Application – A
Rapid Approval Route
The 505(b)(2) application is one of three
established types of new drug application
(NDA), and it is a pathway to approval that
can potentially save pharmaceutical
sponsors both time and money
23
24. Basics of the 505(b)(2)
Considered a full NDA
Must be the same active product (API)
Reporting requirements
Previously reported safety and efficacy
Information from studies not conducted by applicant
Relying on FDA’s prior conclusions on safety and/or
efficacy from
Non-clinical or Clinical
Information where applicant lacks the right of reference
New studies to support change
24
25. NDA 505(b)(2)
Products allowed under 505(b)(2):
Changes to previously approved drugs
Dosage regimen
API change (salt, ester, complex, chelate,)
New indication
Rx/OTC switch
Bioinequivalent to, but not inferior bioavailability
compared to the Reference Listed Drug (RLD)
Formulation changes outside 505(j) limits
Can not be used for products eligible for ANDA
26. NDA 505(b)(2)
Products not allowed under 505(b)(2):
• That are covered under Section 505(j)
• For which the only difference is lower
extent of absorption than reference drug
• For which the only difference is an
unintended lower rate of absorption than
reference drug
26
27. 505(b)(2) NDA Examples
Route of Administration
IV to other parenteral routes
Active Ingredient
Change in salt, racemate or enantiomer
New Molecular Entity
Prodrug of an approved drug
Active metabolite of an approved drug
New combination product
Combining actives previously approved individually
Formulation change
Excipient not allowed under 505(j)
27
28. The 505(b)(2) Process
Major Elements
Meetings and Materials
Pre-IND
EOP2
Pre-NDA (pre-BLA)
Submissions
IND
NDA
FDA Interactions 28
29. CONCLUSION
The IND application allows a company to initiate and
conduct clinical studies of their new drug product.
The Orange Book is also the authoritative source of
information on the therapeutic equivalence of drug
products.
The 505(b)(2) pathway is potentially low risk and has
advantages in regards to time and money
and,perhaps,exclusivity. Can get early FDA feedback
29