This document discusses new drug applications (NDAs) and abbreviated new drug applications (ANDAs) submitted to the FDA for drug approval. It describes the goals and contents of an NDA, including clinical trial data and manufacturing information, as well as the multi-step review process. For ANDAs, the goals are to reduce drug costs and development time by allowing generics if they are equivalent to branded drugs. ANDAs must demonstrate bioequivalence but do not require new clinical trials. The document provides details on patent certification and approval processes for both NDA and ANDA submissions.
Yuvraj Regmi on Hatch-Waxman Act and Amendments and CFRYUVRAJ REGMI
VERY USEFUL PPT FOR UNDERSTANDING HACTH WAXMAN ACT AND CODE OF FEDERAL REGULATION.
THIS PPT HAS BEEN PREPARED FROM VARIOUS SOURCES AVAILABLE ON INTERNET.
I. INTRODUCTION
II. DEFINITIONS
III. TYPES OF DRUG MASTER FILES
IV. SUBMISSIONS TO DRUG MASTER FILES
V. AUTHORIZATION TO REFER TO A DRUG MASTER FILE
VI. PROCESSING AND REVIEWING POLICIES
VII. HOLDER OBLIGATIONS
IX. CLOSURE OF A DRUG MASTER FILE.
COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN DRUG REGULATORY AFFAIRS ...Pristyn Research Solutions
THESE ARE SOME COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN DRUG REGULATORY AFFAIRS INTERVIEW
FOR ENROLLMENT CALL US ON - 9028839789
https://pristynresearch.com/
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International Journal of Drug Regulatory Affairs; 2014, 2(1), 1- 11
Abstract:
Developing a new drug requires great amount of research work in chemistry, manufacturing, controls, preclinical science and clinical trials. Drug reviewers in regulatory agencies around the world bear the responsibility of evaluating whether the research data support the safety, effectiveness and quality control of a new drug product to serve the public health. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. This article focuses on drug approval process in different countries like USA, Europe and India.
Yuvraj Regmi on Hatch-Waxman Act and Amendments and CFRYUVRAJ REGMI
VERY USEFUL PPT FOR UNDERSTANDING HACTH WAXMAN ACT AND CODE OF FEDERAL REGULATION.
THIS PPT HAS BEEN PREPARED FROM VARIOUS SOURCES AVAILABLE ON INTERNET.
I. INTRODUCTION
II. DEFINITIONS
III. TYPES OF DRUG MASTER FILES
IV. SUBMISSIONS TO DRUG MASTER FILES
V. AUTHORIZATION TO REFER TO A DRUG MASTER FILE
VI. PROCESSING AND REVIEWING POLICIES
VII. HOLDER OBLIGATIONS
IX. CLOSURE OF A DRUG MASTER FILE.
COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN DRUG REGULATORY AFFAIRS ...Pristyn Research Solutions
THESE ARE SOME COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN DRUG REGULATORY AFFAIRS INTERVIEW
FOR ENROLLMENT CALL US ON - 9028839789
https://pristynresearch.com/
MAIL ID - pristynresearch@gmail.com
FACEBOOK- https://www.facebook.com/pristynsolutions
INSTAGRAM- https://www.instagram.com/pristyn_res...
TWITTER- https://twitter.com/Pristynresearch
SLIDESHARE- https://www.slideshare.net/azherkhan5916
LINKEDIN- https://www.linkedin.com/in/pristyn-research-191072119/
ADDRESS-
1) Parmar Trade Centre, A-wing,105/106, Sadhu Vaswani Chowk, Pune, 411001. Email: info@pristynresearch.com Phone: 09028839789
2)T-21/4 ,Opposite To Expert Global, Garware Stadium Road , Software Technology Park of India(STPI), MIDC, Aurangabad-431001. Email: info@pristynresearch.com Call us: 09607709586
International Journal of Drug Regulatory Affairs; 2014, 2(1), 1- 11
Abstract:
Developing a new drug requires great amount of research work in chemistry, manufacturing, controls, preclinical science and clinical trials. Drug reviewers in regulatory agencies around the world bear the responsibility of evaluating whether the research data support the safety, effectiveness and quality control of a new drug product to serve the public health. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. This article focuses on drug approval process in different countries like USA, Europe and India.
Process development considerations for quality and safety of vaccinesDr. Priyabrata Pattnaik
"New Technologies Symposium" presentation at Annual General Meeting of Developing Country Vaccine Manufacturers Network (DCVMN), 5th-7th October 2015, Bangkok, Thailand.
“CSR is a detailed regulatory document which gives the information about the methods and results (related to efficacy and safety) of a clinical trial. CSRs are created as a part of the process of submitting applications to the Regulatory Authorities for new medical treatments and for its approval. CSRs can be full, abbreviated, synopsis, supplementary, observational etc as per the results and requirements”.
Regulations for drug approval in USA, E.U & India
Pharmaceutical industry is the most regulated of all the industries. Regulations are put in order to develop the most efficient and safe pharmaceutical products. It takes more than 8 to 15 years to develop a new drug product & costs more than $ 800 million.
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.
Introduction:
RNA interference (RNAi) or Post-Transcriptional Gene Silencing (PTGS) is an important biological process for modulating eukaryotic gene expression.
It is highly conserved process of posttranscriptional gene silencing by which double stranded RNA (dsRNA) causes sequence-specific degradation of mRNA sequences.
dsRNA-induced gene silencing (RNAi) is reported in a wide range of eukaryotes ranging from worms, insects, mammals and plants.
This process mediates resistance to both endogenous parasitic and exogenous pathogenic nucleic acids, and regulates the expression of protein-coding genes.
What are small ncRNAs?
micro RNA (miRNA)
short interfering RNA (siRNA)
Properties of small non-coding RNA:
Involved in silencing mRNA transcripts.
Called “small” because they are usually only about 21-24 nucleotides long.
Synthesized by first cutting up longer precursor sequences (like the 61nt one that Lee discovered).
Silence an mRNA by base pairing with some sequence on the mRNA.
Discovery of siRNA?
The first small RNA:
In 1993 Rosalind Lee (Victor Ambros lab) was studying a non- coding gene in C. elegans, lin-4, that was involved in silencing of another gene, lin-14, at the appropriate time in the
development of the worm C. elegans.
Two small transcripts of lin-4 (22nt and 61nt) were found to be complementary to a sequence in the 3' UTR of lin-14.
Because lin-4 encoded no protein, she deduced that it must be these transcripts that are causing the silencing by RNA-RNA interactions.
Types of RNAi ( non coding RNA)
MiRNA
Length (23-25 nt)
Trans acting
Binds with target MRNA in mismatch
Translation inhibition
Si RNA
Length 21 nt.
Cis acting
Bind with target Mrna in perfect complementary sequence
Piwi-RNA
Length ; 25 to 36 nt.
Expressed in Germ Cells
Regulates trnasposomes activity
MECHANISM OF RNAI:
First the double-stranded RNA teams up with a protein complex named Dicer, which cuts the long RNA into short pieces.
Then another protein complex called RISC (RNA-induced silencing complex) discards one of the two RNA strands.
The RISC-docked, single-stranded RNA then pairs with the homologous mRNA and destroys it.
THE RISC COMPLEX:
RISC is large(>500kD) RNA multi- protein Binding complex which triggers MRNA degradation in response to MRNA
Unwinding of double stranded Si RNA by ATP independent Helicase
Active component of RISC is Ago proteins( ENDONUCLEASE) which cleave target MRNA.
DICER: endonuclease (RNase Family III)
Argonaute: Central Component of the RNA-Induced Silencing Complex (RISC)
One strand of the dsRNA produced by Dicer is retained in the RISC complex in association with Argonaute
ARGONAUTE PROTEIN :
1.PAZ(PIWI/Argonaute/ Zwille)- Recognition of target MRNA
2.PIWI (p-element induced wimpy Testis)- breaks Phosphodiester bond of mRNA.)RNAse H activity.
MiRNA:
The Double-stranded RNAs are naturally produced in eukaryotic cells during development, and they have a key role in regulating gene expression .
Richard's aventures in two entangled wonderlandsRichard Gill
Since the loophole-free Bell experiments of 2020 and the Nobel prizes in physics of 2022, critics of Bell's work have retreated to the fortress of super-determinism. Now, super-determinism is a derogatory word - it just means "determinism". Palmer, Hance and Hossenfelder argue that quantum mechanics and determinism are not incompatible, using a sophisticated mathematical construction based on a subtle thinning of allowed states and measurements in quantum mechanics, such that what is left appears to make Bell's argument fail, without altering the empirical predictions of quantum mechanics. I think however that it is a smoke screen, and the slogan "lost in math" comes to my mind. I will discuss some other recent disproofs of Bell's theorem using the language of causality based on causal graphs. Causal thinking is also central to law and justice. I will mention surprising connections to my work on serial killer nurse cases, in particular the Dutch case of Lucia de Berk and the current UK case of Lucy Letby.
Nutraceutical market, scope and growth: Herbal drug technologyLokesh Patil
As consumer awareness of health and wellness rises, the nutraceutical market—which includes goods like functional meals, drinks, and dietary supplements that provide health advantages beyond basic nutrition—is growing significantly. As healthcare expenses rise, the population ages, and people want natural and preventative health solutions more and more, this industry is increasing quickly. Further driving market expansion are product formulation innovations and the use of cutting-edge technology for customized nutrition. With its worldwide reach, the nutraceutical industry is expected to keep growing and provide significant chances for research and investment in a number of categories, including vitamins, minerals, probiotics, and herbal supplements.
Professional air quality monitoring systems provide immediate, on-site data for analysis, compliance, and decision-making.
Monitor common gases, weather parameters, particulates.
Seminar of U.V. Spectroscopy by SAMIR PANDASAMIR PANDA
Spectroscopy is a branch of science dealing the study of interaction of electromagnetic radiation with matter.
Ultraviolet-visible spectroscopy refers to absorption spectroscopy or reflect spectroscopy in the UV-VIS spectral region.
Ultraviolet-visible spectroscopy is an analytical method that can measure the amount of light received by the analyte.
(May 29th, 2024) Advancements in Intravital Microscopy- Insights for Preclini...Scintica Instrumentation
Intravital microscopy (IVM) is a powerful tool utilized to study cellular behavior over time and space in vivo. Much of our understanding of cell biology has been accomplished using various in vitro and ex vivo methods; however, these studies do not necessarily reflect the natural dynamics of biological processes. Unlike traditional cell culture or fixed tissue imaging, IVM allows for the ultra-fast high-resolution imaging of cellular processes over time and space and were studied in its natural environment. Real-time visualization of biological processes in the context of an intact organism helps maintain physiological relevance and provide insights into the progression of disease, response to treatments or developmental processes.
In this webinar we give an overview of advanced applications of the IVM system in preclinical research. IVIM technology is a provider of all-in-one intravital microscopy systems and solutions optimized for in vivo imaging of live animal models at sub-micron resolution. The system’s unique features and user-friendly software enables researchers to probe fast dynamic biological processes such as immune cell tracking, cell-cell interaction as well as vascularization and tumor metastasis with exceptional detail. This webinar will also give an overview of IVM being utilized in drug development, offering a view into the intricate interaction between drugs/nanoparticles and tissues in vivo and allows for the evaluation of therapeutic intervention in a variety of tissues and organs. This interdisciplinary collaboration continues to drive the advancements of novel therapeutic strategies.
Richard's entangled aventures in wonderlandRichard Gill
Since the loophole-free Bell experiments of 2020 and the Nobel prizes in physics of 2022, critics of Bell's work have retreated to the fortress of super-determinism. Now, super-determinism is a derogatory word - it just means "determinism". Palmer, Hance and Hossenfelder argue that quantum mechanics and determinism are not incompatible, using a sophisticated mathematical construction based on a subtle thinning of allowed states and measurements in quantum mechanics, such that what is left appears to make Bell's argument fail, without altering the empirical predictions of quantum mechanics. I think however that it is a smoke screen, and the slogan "lost in math" comes to my mind. I will discuss some other recent disproofs of Bell's theorem using the language of causality based on causal graphs. Causal thinking is also central to law and justice. I will mention surprising connections to my work on serial killer nurse cases, in particular the Dutch case of Lucia de Berk and the current UK case of Lucy Letby.
This presentation explores a brief idea about the structural and functional attributes of nucleotides, the structure and function of genetic materials along with the impact of UV rays and pH upon them.
What is greenhouse gasses and how many gasses are there to affect the Earth.moosaasad1975
What are greenhouse gasses how they affect the earth and its environment what is the future of the environment and earth how the weather and the climate effects.
What is greenhouse gasses and how many gasses are there to affect the Earth.
NDS V'S ANDA
1. PRESENTED BY
Sneh Priya
Roll no-080603011
M Pharm part-1
Dept of Pharmaceutics
1
2. Contents:
1.New Drug Application
a) Introduction.
b) Goal of NDA
c) Classification of NDA
d) New drug development review
e) NDA content
f ) NDA review process flow chart
g) The NDA in CTD Format
2. Abbreviated new drug application
a) Introduction
b) Goal of ANDA
c) ANDA contents
d) ANDA review process flow chart
e)Patent certification condition
3. Conclusion.
4. References. 2
3. New Drug Application
Introduction
Critical component for drug approval process
which required to submit to USFDA before drug
commercialization.
The data gathered during the animal studies and
human clinical trials of an Investigational New Drug
(IND) become part of the NDA.
Goal
The NDA provide enough information to permit
FDA reviewer to reach safety, efficacy and quality for
pharmaceutical production
3
4. NDA Classifications
New Molecular Entity
New Salt of Previously Approved Drug (not a new molecular entity)
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
4
5. New Drug Development and Review Process
Steps from Test Tube to New Drug Application Review
5
6. Phases of clinical testing
Phase Number of
patients
Length Purpose Percent
successfully
completing
Phase1 20-100 Several months Mainly safety
67
Phase2 Up to several
hundred
Several months
to two years
Some short-term
safety but mainly
effectiveness
45
Phase3 Several hundred
to several
thousand
1-4 years Safety,
effectiveness,
dosage
5-10
6
10. NDA CONTENTS
Section 1: Overall NDA index:-
The NDA index is a comprehensive table of contents that
enables the reviewers to find specific information in this
massive document quickly.
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.
10
11. CONTD....
Section 3: Application summary
Proposed annotated package insert
Pharmacology class, scientific rational, intended use, and
potential clinical benefits
Foreign marketing history
Chemistry, Manufacturing and control summary
Nonclinical pharmacology and toxicology summary
Human pharmacokinetics and bioavailability summary
Microbiology summary
Clinical data summary and results of statistical analysis
Discussion of benefit/risk relationship
11
12. CONTD....…
Section 4: Chemistry, manufacturing and controls
Chemistry, manufacturing and control information
Samples
Methods 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 act ion (if know n)
Interactions with other drugs (or cross-reference the location
of the information in any of the above subsection 12
13. CONTD....
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
Bioavailibility or bioequivalence studies
Pharmacokinetic studies
In vitro studies 13
14. CONTD....
Section 7: Microbiology
Includes 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
14
15. CONTD....
Section 8: Clinical data
Includes.
List of investigators and list of INDs and NDAs
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 15
16. CONTD....
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
16
17. CONTD....
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.
17
18. Contd…..
Application itself consists of a cover letter and a completed form
FDA-356h along with several other supporting items as
appropriate
Item 13: Patent information
Item 14: Patent certification
Item 15: Establishment description
Item 16: Debarment certification
Item 17: Field copy certification
Item 18: User fee cover sheet (Form FDA-3397)
Item 19: Financial disclosure (Form FDA 3454, form FDA-
3455)
Item 20: Other/pediatric use
18
19. The NDA in CTD Format
Module 1 is not part of the CTD because it is not harmonized.
CTD NDA: 314.50
Module 1 a) Application form
c)2.1 Annotated text of proposed
labeling
e)Samples and Labeling
h)Patent information
i) Patent certification
j)Claimed exclusivity
Module 2 c)Summaries
d)5.7 Abuse potential
Module 3 d)1 CMC
Module 4 d)2 Nonclinical pharm/tox
Module d)3 Human PK
d)4 Microbiology
d)5 Clinical data
d)6 Statistical section
f) CRF and CRT 19
20. Abbreviated New Drug Application
(ANDA)
“A drug product that is comparable to a brand/reference listed drug
product in dosage form, strength, route of administration,
quality and performance characteristics, and intended use”
termed "abbreviated" because they generally not required to
include preclinical (animal) and clinical (human) data to
establish safety and effectiveness.
Basic Generic Drug Requirements are:--
Same active ingredient(s)
Same route of administration
Same dosage form
Same strength
Same conditions of use
Inactive ingredients already approved in a similar NDA 20
21. Goal of ANDA
To reduce the price of the drug.
To reduce the time development.
Increase the bioavailability of the drug in comparison
to references list drug.
21
23. NDA vs. ANDA Review Process
NDA Requirement ANDA Requirement
23
24. What is Bioequivalence?
A generic drug is considered to be bioequivalent to the
brand name drug if:
The rate and extent of absorption do not show a
significant difference from listed drug, or
The extent of absorption does not show a significant
difference and any difference in rate is intentional or
not medically significant
24
25. Patent Certification condition for
ANDA
Described in section 505(j)(2)(A)(vii) of the Act.
I Patent Not Submitted to FDA –
approval effective after OGD scientific determination
II Patent Expired –
approval effective after OGD scientific determination
III Patent Expiration Date (honored) –
tentative approval after OGD scientific determination,
final approval when patent expires
IV Patent Challenge –
tentative approval after OGD science determination, final
approval when challenge won
25
26. Paragraph IV certification
According to section 505(j)(2)(B)(i), 2157 CFR
The ANDA applicant must provide appropriate notice of a
paragraph IV certification to each owner of the patent that is
the subject of the certification and to the holder of the
approved NDA to which the ANDA refers
And by Section 505(j)(5)(B)(iv)
An incentive for generic manufacturers to file paragraph IV
certifications and to challenge listed patents as invalid, or not
infringed, by providing for a 180-day period of marketing
exclusivity
26
27. Patent Challenge Successful – Award of
180-Day Exclusivity Period
Awarded to first ANDA holder to file a complete
application with patent challenge
Protection from other generic competition – blocks
approval of subsequent ANDAs
Protection triggered by:
First commercial marketing
Forfeiture provisions
27
28. Orphan Drug Exclusivity (ODE)
Orphan drug refers to a product that treats a rare disease -
affecting fewer than 200,000 Americans
7 years exclusivity
Granted on approval of designated orphan drug
OGD works with the Office of Orphan Products
28
30. CONCLUSION
NDA
ANDA
Applicable for new drug Applicable for generic drug
Take longer time ( 12-15 years) Compare to NAD less time
taken(1-2 years)
More expenditure of money Comparatively less
Cost of drugs are more Cost of drugs are less
Nonclinical studies and clinical
investigations are essential
Nonclinical studies and clinical
investigations are nonessential
except bioavailability and
bioequivalence
30
31. REFERENCES
Douglas J. Pisano $ David S. Manlus –FDA Regulatory Affairs, A
guide for Prescription Drugs, Medical Devices and Biologics-
New drug Application –Second edition-Marcel Dekker,inc- page
no 69-108.
Richard A. Guarino- New Drug Approval process-1)The New
Drug Application, Content, Format 2) Abbreviated $
Supplementary New Drug Application- Fourth edition-Marcel
Dekker,inc- page no 113-183.
Loyd V. Allen Jr, Nicholas G. Popovich, Howard C. ansel-Ansel’s
Pharmaceutical Dosage Forms and delivers systems- New Drug
Development and Approval Process-8th edition- B.I. publication-
Page no 25-65.
http://www.fda.gov/cder/guidance/index.htm.
31