New drug application submitted by the manufacture of a drug to the FDA-after clinical trials have been completed –for a license to market the drug for a specified.
Clinical evaluation and the latest 2016 guidelineGRCTS
This “General Guidance” document promotes a common approach to clinical evaluation for "medical devices regulated by directives 90/385/EEC and 93/42/EEC. It does not concern in vitro diagnostic devices. The depth and extent of clinical evaluations should be flexible and appropriate to the nature, intended purpose, and risks of the device in question.
B PHARAM 6TH SEM
PHARAMACEUTICAL QUALITY ASSURANCE
COMPLAINT
Reasons
Types of Complaint
Steps involved in Handling of complaints
Product Complaint Data Sheet
Complaint Record
Regulatory Guidelines
SOP on Complaint Handling
RECALL
Reasons
Types of Recall
Recall Classification
Levels of Recall
How to Recall the Product?
How To Notify The Consumers?
Regulatory Guidelines
SOP on Product Recall
DRUG RECALL IN 2013 AND 2014
What Is An Assistant Drug Controller (Adc) Noc In India And Why Is It Importa...PranshuCorpseed
The pharmaceutical industry plays a pivotal role in public health by manufacturing and distributing drugs and medical products. To ensure the safety, quality, and efficacy of pharmaceuticals, governments around the world have established stringent regulatory frameworks. In India, the Assistant Drug Controller (ADC) assumes a crucial role in this regulatory process. This article delves into the significance of an Assistant Drug Controller (ADC) No Objection Certificate (NOC) in India and its pivotal role in the pharmaceutical sector.
Overcoming Regulatory, Clinical and Quality Challenges in Developing Combinat...Michael Swit
Webinar presented on May 19, 2011, sponsored by The Weinberg Group, focusing on:
* A Brief History of Combination Product Regulation
* Primary Mode of Action (PMOA) –The Key Lynchpin to FDA’s Regulatory Regime for Combination Products
* The Request for Designation (RFD) Process
* GMPs
* Post-Market Safety Reporting
* How Many Applications to File?
* User Fees
Indian regulatory requirements - industrial pharmacy 2Jafarali Masi
Indian Regulatory Requirements: Central Drug Standard Control Organization (CDSCO) and State Licensing Authority: Organization, Responsibilities, Certificate of Pharmaceutical Product (COPP), Regulatory requirements and approval procedures for New Drugs
Regulation Governing Clinical Trials In India,USA and Europe. KapilKumar198
This presentation contain detailed information about the "Regulation Governing Clinical Trials In India,USA and Europe".And about the clinical trails and medical devices regulations in India.
Joint San Diego Chapters CLMA AACC / May 16 2010 Mtg Robert Parsonbpstat
With closer scrutiny by public and private payers of laboratory tests and their importance to medicine, evidence for their appropriate use often is limited and their cost effectiveness too often misunderstood.
The presentation will review the expanding use of evaluation processes and methodologies by which laboratory tests are evaluated and reimbursed. Learn the strategies manufacturers, laboratory service providers, and payers employ to collect outcome and cost data to better support the effective use of new laboratory tests which in turn increases appropriate use and reimbursement. What common language, nomenclature and information should be used to present that facilitates an open, straightforward dialogue from the development, review, and delivery of evidence-based findings by manufacturers, clinical laboratories, and healthcare providers to those entities that make coverage and reimbursement decisions.
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.
Medical Device Single Audit Program (MDSAP)EMMAIntl
In 2012, the International Medical Device Regulators Forum (IMDRF) developed the Medical Device Single Audit Program (MDSAP) to implement a harmonized and a global approach to audit medical device manufacturers. The program allows for MDSAP recognized organizations to conduct a single audit that satisfies the regulatory requirements of the countries participating in the program
New drug application submitted by the manufacture of a drug to the FDA-after clinical trials have been completed –for a license to market the drug for a specified.
Clinical evaluation and the latest 2016 guidelineGRCTS
This “General Guidance” document promotes a common approach to clinical evaluation for "medical devices regulated by directives 90/385/EEC and 93/42/EEC. It does not concern in vitro diagnostic devices. The depth and extent of clinical evaluations should be flexible and appropriate to the nature, intended purpose, and risks of the device in question.
B PHARAM 6TH SEM
PHARAMACEUTICAL QUALITY ASSURANCE
COMPLAINT
Reasons
Types of Complaint
Steps involved in Handling of complaints
Product Complaint Data Sheet
Complaint Record
Regulatory Guidelines
SOP on Complaint Handling
RECALL
Reasons
Types of Recall
Recall Classification
Levels of Recall
How to Recall the Product?
How To Notify The Consumers?
Regulatory Guidelines
SOP on Product Recall
DRUG RECALL IN 2013 AND 2014
What Is An Assistant Drug Controller (Adc) Noc In India And Why Is It Importa...PranshuCorpseed
The pharmaceutical industry plays a pivotal role in public health by manufacturing and distributing drugs and medical products. To ensure the safety, quality, and efficacy of pharmaceuticals, governments around the world have established stringent regulatory frameworks. In India, the Assistant Drug Controller (ADC) assumes a crucial role in this regulatory process. This article delves into the significance of an Assistant Drug Controller (ADC) No Objection Certificate (NOC) in India and its pivotal role in the pharmaceutical sector.
Overcoming Regulatory, Clinical and Quality Challenges in Developing Combinat...Michael Swit
Webinar presented on May 19, 2011, sponsored by The Weinberg Group, focusing on:
* A Brief History of Combination Product Regulation
* Primary Mode of Action (PMOA) –The Key Lynchpin to FDA’s Regulatory Regime for Combination Products
* The Request for Designation (RFD) Process
* GMPs
* Post-Market Safety Reporting
* How Many Applications to File?
* User Fees
Indian regulatory requirements - industrial pharmacy 2Jafarali Masi
Indian Regulatory Requirements: Central Drug Standard Control Organization (CDSCO) and State Licensing Authority: Organization, Responsibilities, Certificate of Pharmaceutical Product (COPP), Regulatory requirements and approval procedures for New Drugs
Regulation Governing Clinical Trials In India,USA and Europe. KapilKumar198
This presentation contain detailed information about the "Regulation Governing Clinical Trials In India,USA and Europe".And about the clinical trails and medical devices regulations in India.
Joint San Diego Chapters CLMA AACC / May 16 2010 Mtg Robert Parsonbpstat
With closer scrutiny by public and private payers of laboratory tests and their importance to medicine, evidence for their appropriate use often is limited and their cost effectiveness too often misunderstood.
The presentation will review the expanding use of evaluation processes and methodologies by which laboratory tests are evaluated and reimbursed. Learn the strategies manufacturers, laboratory service providers, and payers employ to collect outcome and cost data to better support the effective use of new laboratory tests which in turn increases appropriate use and reimbursement. What common language, nomenclature and information should be used to present that facilitates an open, straightforward dialogue from the development, review, and delivery of evidence-based findings by manufacturers, clinical laboratories, and healthcare providers to those entities that make coverage and reimbursement decisions.
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.
Medical Device Single Audit Program (MDSAP)EMMAIntl
In 2012, the International Medical Device Regulators Forum (IMDRF) developed the Medical Device Single Audit Program (MDSAP) to implement a harmonized and a global approach to audit medical device manufacturers. The program allows for MDSAP recognized organizations to conduct a single audit that satisfies the regulatory requirements of the countries participating in the program
Transport models : Permeability , solubility , charge state amd the ph partit...NishaN19p7504
this topic is all about influence of ph on drug solubilty and permeability , henderson hasselbalch equation , PH partition hypothesis and its deviations
Observation of Io’s Resurfacing via Plume Deposition Using Ground-based Adapt...Sérgio Sacani
Since volcanic activity was first discovered on Io from Voyager images in 1979, changes
on Io’s surface have been monitored from both spacecraft and ground-based telescopes.
Here, we present the highest spatial resolution images of Io ever obtained from a groundbased telescope. These images, acquired by the SHARK-VIS instrument on the Large
Binocular Telescope, show evidence of a major resurfacing event on Io’s trailing hemisphere. When compared to the most recent spacecraft images, the SHARK-VIS images
show that a plume deposit from a powerful eruption at Pillan Patera has covered part
of the long-lived Pele plume deposit. Although this type of resurfacing event may be common on Io, few have been detected due to the rarity of spacecraft visits and the previously low spatial resolution available from Earth-based telescopes. The SHARK-VIS instrument ushers in a new era of high resolution imaging of Io’s surface using adaptive
optics at visible wavelengths.
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.
Earliest Galaxies in the JADES Origins Field: Luminosity Function and Cosmic ...Sérgio Sacani
We characterize the earliest galaxy population in the JADES Origins Field (JOF), the deepest
imaging field observed with JWST. We make use of the ancillary Hubble optical images (5 filters
spanning 0.4−0.9µm) and novel JWST images with 14 filters spanning 0.8−5µm, including 7 mediumband filters, and reaching total exposure times of up to 46 hours per filter. We combine all our data
at > 2.3µm to construct an ultradeep image, reaching as deep as ≈ 31.4 AB mag in the stack and
30.3-31.0 AB mag (5σ, r = 0.1” circular aperture) in individual filters. We measure photometric
redshifts and use robust selection criteria to identify a sample of eight galaxy candidates at redshifts
z = 11.5 − 15. These objects show compact half-light radii of R1/2 ∼ 50 − 200pc, stellar masses of
M⋆ ∼ 107−108M⊙, and star-formation rates of SFR ∼ 0.1−1 M⊙ yr−1
. Our search finds no candidates
at 15 < z < 20, placing upper limits at these redshifts. We develop a forward modeling approach to
infer the properties of the evolving luminosity function without binning in redshift or luminosity that
marginalizes over the photometric redshift uncertainty of our candidate galaxies and incorporates the
impact of non-detections. We find a z = 12 luminosity function in good agreement with prior results,
and that the luminosity function normalization and UV luminosity density decline by a factor of ∼ 2.5
from z = 12 to z = 14. We discuss the possible implications of our results in the context of theoretical
models for evolution of the dark matter halo mass function.
Cancer cell metabolism: special Reference to Lactate PathwayAADYARAJPANDEY1
Normal Cell Metabolism:
Cellular respiration describes the series of steps that cells use to break down sugar and other chemicals to get the energy we need to function.
Energy is stored in the bonds of glucose and when glucose is broken down, much of that energy is released.
Cell utilize energy in the form of ATP.
The first step of respiration is called glycolysis. In a series of steps, glycolysis breaks glucose into two smaller molecules - a chemical called pyruvate. A small amount of ATP is formed during this process.
Most healthy cells continue the breakdown in a second process, called the Kreb's cycle. The Kreb's cycle allows cells to “burn” the pyruvates made in glycolysis to get more ATP.
The last step in the breakdown of glucose is called oxidative phosphorylation (Ox-Phos).
It takes place in specialized cell structures called mitochondria. This process produces a large amount of ATP. Importantly, cells need oxygen to complete oxidative phosphorylation.
If a cell completes only glycolysis, only 2 molecules of ATP are made per glucose. However, if the cell completes the entire respiration process (glycolysis - Kreb's - oxidative phosphorylation), about 36 molecules of ATP are created, giving it much more energy to use.
IN CANCER CELL:
Unlike healthy cells that "burn" the entire molecule of sugar to capture a large amount of energy as ATP, cancer cells are wasteful.
Cancer cells only partially break down sugar molecules. They overuse the first step of respiration, glycolysis. They frequently do not complete the second step, oxidative phosphorylation.
This results in only 2 molecules of ATP per each glucose molecule instead of the 36 or so ATPs healthy cells gain. As a result, cancer cells need to use a lot more sugar molecules to get enough energy to survive.
Unlike healthy cells that "burn" the entire molecule of sugar to capture a large amount of energy as ATP, cancer cells are wasteful.
Cancer cells only partially break down sugar molecules. They overuse the first step of respiration, glycolysis. They frequently do not complete the second step, oxidative phosphorylation.
This results in only 2 molecules of ATP per each glucose molecule instead of the 36 or so ATPs healthy cells gain. As a result, cancer cells need to use a lot more sugar molecules to get enough energy to survive.
introduction to WARBERG PHENOMENA:
WARBURG EFFECT Usually, cancer cells are highly glycolytic (glucose addiction) and take up more glucose than do normal cells from outside.
Otto Heinrich Warburg (; 8 October 1883 – 1 August 1970) In 1931 was awarded the Nobel Prize in Physiology for his "discovery of the nature and mode of action of the respiratory enzyme.
WARNBURG EFFECT : cancer cells under aerobic (well-oxygenated) conditions to metabolize glucose to lactate (aerobic glycolysis) is known as the Warburg effect. Warburg made the observation that tumor slices consume glucose and secrete lactate at a higher rate than normal tissues.
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 .
(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.
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.
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.
THE IMPORTANCE OF MARTIAN ATMOSPHERE SAMPLE RETURN.Sérgio Sacani
The return of a sample of near-surface atmosphere from Mars would facilitate answers to several first-order science questions surrounding the formation and evolution of the planet. One of the important aspects of terrestrial planet formation in general is the role that primary atmospheres played in influencing the chemistry and structure of the planets and their antecedents. Studies of the martian atmosphere can be used to investigate the role of a primary atmosphere in its history. Atmosphere samples would also inform our understanding of the near-surface chemistry of the planet, and ultimately the prospects for life. High-precision isotopic analyses of constituent gases are needed to address these questions, requiring that the analyses are made on returned samples rather than in situ.
Multi-source connectivity as the driver of solar wind variability in the heli...Sérgio Sacani
The ambient solar wind that flls the heliosphere originates from multiple
sources in the solar corona and is highly structured. It is often described
as high-speed, relatively homogeneous, plasma streams from coronal
holes and slow-speed, highly variable, streams whose source regions are
under debate. A key goal of ESA/NASA’s Solar Orbiter mission is to identify
solar wind sources and understand what drives the complexity seen in the
heliosphere. By combining magnetic feld modelling and spectroscopic
techniques with high-resolution observations and measurements, we show
that the solar wind variability detected in situ by Solar Orbiter in March
2022 is driven by spatio-temporal changes in the magnetic connectivity to
multiple sources in the solar atmosphere. The magnetic feld footpoints
connected to the spacecraft moved from the boundaries of a coronal hole
to one active region (12961) and then across to another region (12957). This
is refected in the in situ measurements, which show the transition from fast
to highly Alfvénic then to slow solar wind that is disrupted by the arrival of
a coronal mass ejection. Our results describe solar wind variability at 0.5 au
but are applicable to near-Earth observatories.
4. ABBREVIATED NEW DRUG APPLICATION
(ANDA)
These are submitted to the FDA’S CDER
(Center for drug evaluation and research ) .
The office of the generic drugs (OGD) is
located within the CDER under the office of
pharmaceuticals science , to obtain approval to
market a generic drug product.
The OGD ensures the safety and efficacy of
the generic drugs by employing a review
process that is similar to the NDA process .
4
5. Once approved the applicant may manufacture
and market the generic product to provide a safe,
effective and low cost alternative .
These are termed “ Abbreviated “ because they
generally need not include preclinical and clinical data
to establish safety and effectiveness .
They must scientifically demonstrate that their
product is bioequivalent to the innovator drug .
The primary difference between the generic drug
review process and NDA process is the study
requirements .
5
6. For ex : an ANDA generally requires a BE study
between the generic drug product and the reference
list of drugs .
The safety and efficacy of the RLD product were
established previously through animal , clinical , BA
studies . SO , no need to repeat for ANDA.
6
7. STEPS :
1) Filling Review
2) Coordination of generic drug review process
3) Bioequivalence review process
4) Chemistry review process
5) Labeling review process
6) Putting it all together
7
8. FILLING REVIEW
The process begins when the applicant submits
an ANDA to OGD.
The document room staff assigns it an ANDA
number and stamps a received date on the cover
letter of ANDA .
It is sent to consumer safety technician of
review the preliminary sections of ANDA checklist .
Within first 60 days – submission , filling review
is completed . Regulatory support branch (RSB) is
responsible for this process .
8
9. Once the RSB completes filling review of the ANDA
and verifies that the applicant contains all the
necessary regulatory requirements and “
Acknowledgement “ letter is issued to the applicant
indicating its acceptance for the filling and official filling
date .
The applicant is then assigned to technical
reviewers.
If the ANDA does not meet the criteria for filling , a “
refuse - to – receive “ letter is issued with a list of
deficiencies .
9
10. Upon filling an ANDA the RPM ( regulatory program
manager ) forwards an established evaluation request
(EER) to the office of compliance.
Office of compliance are operating in compliance
with current good manufacturing practice (cGMP)
regulations .
Currently ANDA can be submitted electronically .
All applicant who planned to submit ANDA
electronically should consult CDER’s website for
electronic submission .
10
11. COORDINATION OF THE GENERIC
DRUG REVIEW PROCESS :
Now application enters the review queue , this
means that the application is assigned to a
bioequivalence reviewer , a chemist and the
labeling reviewer.
Each chemistry team consists of a team leader
, project manager and several reviewers . The
chemistry project manager serves as a Applicant
Project manager ( APM) , they plan organize and
coordinate all the review activities for the
application that they manage .
11
12. BIOEQUIVALENCE REVIEW PROCESS
Bioequivalence project manager (BPM) access list of
pending ANDA assign to each individual reviewers according
to “ first-in , first-reviewed “ policy .
The DBE’S responsibility include BE section of ANDA , Bio-
investigational applications , protocols and controlled
correspondence .
This process establishes BE between a
proposed generic drug and the RLD .
12
13. CHEMISTRY REVIEW PROCESS
The chemistry , manufacturing and control
(CMC) section of the application is assigned to the
chemistry division and the team based on
therapeutic category of the drug product .
The team leader assign the application to a
reviewer on his/her team according to the first-in ,
first-reviewed policy .
The chemistry division reviews CMC section of
ANDA , drug master file , annual reports , and
controlled correspondence .
13
14. LABELLING REVIEW PROCESS
Labeling section of the application is assigned to
the labeling reviewer based on the therapeutic
category of the drug product .
The labeling review branch is a part of DLPS .
The team leader oversees the work of 4-
6reviewers .
The basics of the labeling review is to ensure that
the generic drug labeling is the same as the RLD
labeling .
The labeling reviewer identifies and resolvers
concern about medication errors . 14
15. The reviewer must identify the RLD .
Next step is to find the most recently approved
labeling for the RLD .
If it is not the recently approved , it is considered
as discontinuous .
The applicant may submit four copies of draft
labeling or 12 copies of final printed labeling as the
proposed labeling .
The labeling branch supports the submission of
electronic labeling which is preferred and strongly
encouraged .
15
16. PUTTING IT ALL TOGETHER
After the final office level administrative review
and individual disciplines have resolved their
deficiencies , the application will either receive a
full approval or a tentative letter .
When the review of an ANDA is completed ,
the APMs draft the app approval and circulate it
with reviews and application of occurrence .
The APMs communicate with the OGD
management on a weekly basis to update them on
the progress of reviews .
16
17. A full approval letter details the condition of
approval and allows the applicant to market the
generic drug product .
A tentative approval letter is issued if there are
unexpired patents or exclusivities according to the
RDL , and delays the marketing of product .
Once the office director signs the final approval
letter , APM calls and faxes a copy of approval
letter to the applicant .
The document room staff then mails the final
approval letter to the applicant .
17