Fast track Designation is a designation for accelerated approval of drugs and medicines in US. Presentation contains brief view of this expedite program.
This Slide explains US-FDA requirements for IND. It will answer; What is an IND ?What are the IND Phases ?What is the IND Content?When FDA Terminates an IND ?Are cGMP Required for IND ?What Studies are exempt from IND?
Fast track Designation is a designation for accelerated approval of drugs and medicines in US. Presentation contains brief view of this expedite program.
This Slide explains US-FDA requirements for IND. It will answer; What is an IND ?What are the IND Phases ?What is the IND Content?When FDA Terminates an IND ?Are cGMP Required for IND ?What Studies are exempt from IND?
This powerpoint presentation includes all the details regarding the topic Drug approval process with special procedure of Drug approval process in India.
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
A regulatory strategy is critical to the commercialization of biomedical technologies. In particular, technologies such as new drugs and medical devices have more regulatory needs, and the strategy should be considered simultaneous to a commercialization pathway.
While the world is going through pandemic turmoil and regulatory agencies are under immense stress to approve newer pharmaceutical therapies to market. However, the classical/regular clinical trial is a hefty process hence alternative provisions like speed trials were explored for the early entry of drugs for emergency usage.
This powerpoint presentation includes all the details regarding the topic Drug approval process with special procedure of Drug approval process in India.
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
A regulatory strategy is critical to the commercialization of biomedical technologies. In particular, technologies such as new drugs and medical devices have more regulatory needs, and the strategy should be considered simultaneous to a commercialization pathway.
While the world is going through pandemic turmoil and regulatory agencies are under immense stress to approve newer pharmaceutical therapies to market. However, the classical/regular clinical trial is a hefty process hence alternative provisions like speed trials were explored for the early entry of drugs for emergency usage.
GLOBAL SUBMISSION OF IND, NDA, ANDA.pdfLokeshThakre6
It's important to note that the specific requirements and processes for INDs, NDAs, and ANDAs may vary between regulatory authorities in different countries. The descriptions provided here are general and based on the common practices in the United States.
IND (Investigational New Drug) industrial perspectiveAYESHA NAZEER
Describing the Industry's/sponsor's/drug manufacturers' perspective of the Investigational New Drug Application (IND) program based on the survey conducted by the Office Of Inspector General (OIG).
INTRODUCTION
IND TYPES
IND CATEGORIES
THE IND APPLICATION MUST CONTAIN INFORMATION IN THREE BROAD AREA
THE REGULATORY ENVIRONMENT AND FDA ROLE
LIST OF IMPORTANT SECTIONS
GENERAL PRINCIPLES
INVESTIGATIONAL NEW DRUG GUIDANCE AND PLANNING
FDA FORM 1571
FDA FORM 1572
FDA FORM 3674
SUBMITTING AN IND
FOLLOWING RECEIPT OF IND BY THE FDA
RESPONDING TO A CLINICAL HOLD
REGULATORY REQUIREMENTS FOR AN IND DURING STUDY AND AT COMPLETION
PROTOCOL AMENDMENTS (21 CFR 312.30)
INFORMATION AMENDMENTS (21 CFR 312.31)
SAFETY REPORTS (21 CFR 312.32)
ANNUAL REPORTS (21 CFR 312.33)
WITHDRAWAL, TERMINATION, AND INACTIVATION
MONITORING RESPONSIBILITIES FOR SPONSOR-INVESTIGATORS
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.
Understanding the Drug Development ProcessEMMAIntl
The FDA’s process for drug development can be a lengthy, and often expensive, commitment. If you are developing a new drug product from the beginning, it is critical that you understand the phases of the development process and the deliverables for each. Beginning with R&D, you will have to ensure that your product corresponds with the FDA’s definition of a drug product. Next, it is advised that you conduct sufficient testing to get a baseline understanding of how your product works, what its intended use is, and other product specifications. Once you have completed this first step, you are ready to embark on the drug development journey...
This presentation contains basic fundamentals of entrepreneurship including Definition, advantages and disadvantages, types, functions and factors affecting entrepreneurship...
This presentation provides information about parkinsonism or Parkinson disease and pathophysiology, classification, pharmacological action and side effects of Anti Parkinson drugs.
Indian Patent Act 1970 : This presentation includes definition of Patent, approval process, expiry and withdrawal, its renewal procedure, penalties and various brief topics with explanation of Indian patent act 1970 and its amendments thereafter.
Differential thermal analysis is a type of Thermal Analysis. This presentation includes definition of Thermal analysis, types of thermal analysis with focus on DTA, its principle, Instrumentation and applications.
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Acute scrotum is a general term referring to an emergency condition affecting the contents or the wall of the scrotum.
There are a number of conditions that present acutely, predominantly with pain and/or swelling
A careful and detailed history and examination, and in some cases, investigations allow differentiation between these diagnoses. A prompt diagnosis is essential as the patient may require urgent surgical intervention
Testicular torsion refers to twisting of the spermatic cord, causing ischaemia of the testicle.
Testicular torsion results from inadequate fixation of the testis to the tunica vaginalis producing ischemia from reduced arterial inflow and venous outflow obstruction.
The prevalence of testicular torsion in adult patients hospitalized with acute scrotal pain is approximately 25 to 50 percent
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Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
2. What is a fast track process.
Other similar Expedited programs of FDA
History of Fast track development process
Features of Fast track designation
Approval process of Fast track designation
Withdrawal of a drug from Fast Track designation.
Conclusion
References
3. Fast Track Drug Development is a process
that is designed to accelerate the development
and review of drugs to treat serious conditions
and fill an unmet medical need.
The purpose fast track drugs is to get
important new drugs to the patient earlier.(1)
4. 1. BREAKTHROUGH THERAPY DESIGNATION : It is a
process designed to accelerate the development and review
of drugs which may show substantial improvement over the
current therapy.
2. ACCLERATED APPROVAL : These regulations allow the
drugs for serious conditions to get approved based on
surrogate endpoint.
3. PRIORITY REVIEW DESIGNATION : A priority review
designation means FDA’s goal is to take action on approval
of application within six months.(1)
Other similar Expedited studies under FDAprogram :
5. In 1997, FDA’s Modernization Act directed the
FDA to create a system so that the important new
drugs could reach patients even more quickly.
Thus, then Fast track program was introduced as
fast track designation under section 506(b) of Food,
Drug and Cosmetic Act.
Under this section, FDA may grant approval to
Drug as Fast track designation if two criteria's are
Fulfilled :
6. (a) Serious Condition.
(b) Potential to fulfil the unmet medical need.(3)
Features of Fast track Designation
(a).Expedite Development and Review : Once the
FDA receives a Fast track request, early and
frequently interaction with the review team is
encouraged.
These include meetings with FDA team including
Pre-IND meetings, Design study, Dose response
concerns and use of Bio markers.
7. (b).Rolling review : It means that the Drug company
can submit the filled or completed section of its New
Drug Application to FDA rather than waiting until
every section of its New Drug Application gets
completed.
(c).Ability to address emerging public health need :
Drugs under Fast track designation can be approved or
passed more quickly which may benefit the patient as
the time for drug availability will be less.
(d).Showing superior effect and therapeutic action
on serious and adverse outcomes.(2)
8. Sending a Designation submission
Receiving the Fast Track Request
FDA Review and Response
Approval
9. 1. Sending a Designation Submission
• Sponsors may request Fast Track designation when the
INDA is first submitted or at any time thereafter before
receiving marketing approval of their NDA.
• Usually, FDA should receive the Fast track request no later
than pre-IND meeting with the Agency because once the
meeting is over, no other features of Fast track Designation
will be applied.
• If a sponsor’s drug development program is granted fast
track designation for one indication and has subsequently
obtained data to support fast track designation for another
indication, the sponsor should submit a separate request.
10. 2.Content of Designation Submission :
The request should contain the following information captured
in 15-20 pages and ‘REQUEST FOR FAST TRACK
DESIGNATION’ should be written on cover case in Bold
letters :
The name of Sponsor’s contact person and the contact
details like telephone no. , address, email etc.
If applicable ,the Investigational New Drug Application
number should be mentioned.
For drug products, the proprietary name and active
ingredients and for Biological products, the proper name and
proprietary name should be given.
11. The name of Division or Office to which the IND has been
submitted.
Summary of Information that support Fast track
designation request which includes the following:
Information for considering the drug capability to address
the unmet medical need.
Information for considering the drug capability to treat a
serious condition
3. Receiving the Fast track request :
IND and related documents are received by the Appropriate
review division or by CDER.
12. 4. FDA Response :
FDA will respond to Fast track designation request
within 60 days and will issue Sponsor a Designation
letter or a Non-designation letter
Designation letter : If the agency is satisfied with
the submission of sponsor, they may issue a
designation letter.
Non-designation letter : If the agency was not
satisfied with the submission of sponsor, they may
issue a non designation letter. The reason may be
stated as drug failed to meet the criteria for Fast track
designation.(4)
13. Withdrawal of Fast Track Designation
Over the years of drug development, it is expected that some
drugs which are granted Fast track designation will not meet
the Criteria for fast track later.
This may be due to reason that new and advanced drugs are
discovered and the Fast track drug no longer shows a active
potential to address unmet medical need.
If the sponsor recognizes that Fast track drug development
program will no longer be continued, same must be informed
to Agency.
The Agency then send a confirmation letter to the sponsor
indicating the end of his Fast track designation.(4)
14. Fast Track Approved drugs
NDA
Reg. No.
Name of the Drug Applicant Approval
Date
Therapeutic Use
N22268 COARTEM NOVARTIS 4/07/2009 Malaria treatment
N22059 TYKERB GSK 26/2/2010 Over expressing
Breast Cancer
N21991 ZOLINZA MERCK 10/6/2006 T-cell lymphoma
treatment
N21937 ATRIPLA GILEAD
SCIENCES
7/12/2006 Treatment of HIV
N21882 EXJADE NOVARTIS 12/1/2004 Chronic Iron overdose
Treatment
N22041 CYANOKIT EMD 12/5/2006 Suspected cyanide
poisoning
Here are few examples of fast track drugs (5)
15. SUMMARY
Fast track designation is a process by which the drug for serious or life
threatening disease can be developed more rapidly and can be easily
delivered to the patients.
In order to get fast track approval, applicant sends a submission to
agency along with the NDA containing all required information of the
drug.
FDA issues a Designation letter or Non designation letter after review
and verification of details.
Many Fast track drugs are approved from time to time but they can be
recalled if they show adverse effect on patients.
Also, if sponsor feels that he no longer wants to continue fast track
program, he can inform it to Agency.
16. References:
(1) Reichert JM, Rachon SL, Zhang BD, A decade of Fast track
programs, International Journal of Expedite programmes 2008;
7(11):1-4
(2) Chary KV, Expedited drug review process: Fast but flawed, Journal
of Pharmacology and Pharmacotherapeutics 2016; 7(2): 57-61
(3) Shulman SR, Brown JS, Fast track approval program, Journal of
Applied Science and Medical Research 2015; 5(3): 6-10
(4) Henry Wilson, Expedited programs for serious conditions-Drugs
and Biologics, a textbook of guidance for Industry 2014; 5(2): 7-9,
28-33
(5) U.S Food and Drug Administration 2006,Guidance for approval of
fast track drugs; retrieved from fda.gov