The document provides an overview of the drug development and approval process at the US Food and Drug Administration (FDA). It describes the FDA's structure and responsibilities in regulating drugs, medical devices, food, cosmetics, and other products. The key stages of drug development include drug discovery, pre-clinical testing, clinical trials (Phase I-III), and new drug application. FDA approval is required through this rigorous process to ensure safety and effectiveness before a new drug can reach consumers.
This powerpoint presentation includes all the details regarding the topic Drug approval process with special procedure of Drug approval process in India.
Presented By :- Raghav Sharma
Class :- M.Pharm, 1st sem.
Department :- Pharmaceutics
Institute :- Parul Institute of Pharmacy
Content :-
Introduction to Clinical trials
Importance of Clinical Trials
Phase-I of Clinical Trials
Phase-II of Clinical Trials
Phase-III of Clinical Trials
Phase-IV of Clinical Trials
Conclusion
References
Non-clinical contract research organizations (CROs) have become an integral part of drug discovery and development to support sponsors research needs, expedite timelines and provide an extension of technical and scientific support.
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
This presentation enlists all the studies which are required before submission of IND. It include IND introduction , time period of study ,flowchart showing preclinical studies...
CFTCC
2015 Learning about the IND/IDE Process and Reimbursements for New Drugs and Devices
Erin O'Reilly, PhD, RAC
Assoc. Director, Regulatory Affairs
Translational Medicine Institute
Introduces the basics of filing an Investigational New Drug (IND) Application with the FDA
Science Shaping Our World-SHOW: Deconstructing the Drug Development Process: ...MunevarS
June’s SHOW will examine the drug development process and highlight new paradigms for pharmaceutical innovation. In the current pharmaceutical research-based drug industry, the source of many of the medications in use today, economic, regulatory, and competitive pressures are forcing companies to re-evaluate and restructure their research and development (R&D) processes. Our special guest speaker Dr. Kenneth Kaitin will discuss major shifts within the pharmaceutical industry. The industry has been undergoing a transformation from fully-integrated pharmaceutical companies (FIPCos) to a network model (FIPNet) that encompasses all the major stakeholders in drug development including: large and small pharmaceutical and biotechnology companies, academic research institutions, patient groups, public-private-partnerships, and contract research organizations.
This powerpoint presentation includes all the details regarding the topic Drug approval process with special procedure of Drug approval process in India.
Presented By :- Raghav Sharma
Class :- M.Pharm, 1st sem.
Department :- Pharmaceutics
Institute :- Parul Institute of Pharmacy
Content :-
Introduction to Clinical trials
Importance of Clinical Trials
Phase-I of Clinical Trials
Phase-II of Clinical Trials
Phase-III of Clinical Trials
Phase-IV of Clinical Trials
Conclusion
References
Non-clinical contract research organizations (CROs) have become an integral part of drug discovery and development to support sponsors research needs, expedite timelines and provide an extension of technical and scientific support.
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
This presentation enlists all the studies which are required before submission of IND. It include IND introduction , time period of study ,flowchart showing preclinical studies...
CFTCC
2015 Learning about the IND/IDE Process and Reimbursements for New Drugs and Devices
Erin O'Reilly, PhD, RAC
Assoc. Director, Regulatory Affairs
Translational Medicine Institute
Introduces the basics of filing an Investigational New Drug (IND) Application with the FDA
Science Shaping Our World-SHOW: Deconstructing the Drug Development Process: ...MunevarS
June’s SHOW will examine the drug development process and highlight new paradigms for pharmaceutical innovation. In the current pharmaceutical research-based drug industry, the source of many of the medications in use today, economic, regulatory, and competitive pressures are forcing companies to re-evaluate and restructure their research and development (R&D) processes. Our special guest speaker Dr. Kenneth Kaitin will discuss major shifts within the pharmaceutical industry. The industry has been undergoing a transformation from fully-integrated pharmaceutical companies (FIPCos) to a network model (FIPNet) that encompasses all the major stakeholders in drug development including: large and small pharmaceutical and biotechnology companies, academic research institutions, patient groups, public-private-partnerships, and contract research organizations.
Regulatory requirements for drug approval - industrial pharmacy IIJafarali Masi
Regulatory requirements for drug approval - industrial pharmacy IIDrug Development Teams, Non-Clinical Drug Development, Pharmacology, Drug Metabolism and Toxicology, General considerations of Investigational New Drug (IND) Application, Investigator’s Brochure (IB) and New Drug Application (NDA), Clinical research / BE studies, Clinical Research Protocols, Biostatistics in Pharmaceutical Product Development, Data Presentation for FDA Submissions, Management of Clinical Studies.
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
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
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.
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
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.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
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
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
1. A Seminar on
DRUG DEVELOPMENT & DRUG APPROVAL
PROCESS
Submited to
Savitribai Phule , University of Pune
In Partial fulifillment of Requirements for the Award of
Degree of
MASTER OF PHARMACY
IN
QUALITY ASSURANCE TECHNIQUES
Presented by- Guided by-
Miss.Veena.S.Katoriya Dr.Gitanjali S.Deokar
M.Pharm(QAT)Sem III (M.Pharm,Ph.D)
Bhujbal Knowledge City,
MET’S Institute of Pharmacy,
Adgaon,Nashik.
2015-2016
1
2. CONTENTS
• Snapshots of FDA site
• Introduction
-US FDA-General Introduction
• FDA structure/organization
• Food Products
• Drugs
• Drug discovery & Drug development
3.
4.
5.
6.
7. INTRODUCTION
• The Food and Drug Administration (FDA) is an agency within the U.S.
Department of Health and Human Services. It consists of the Office of the
Commissioner and four directorates overseeing the core functions of the
agency: Medical Products and Tobacco, Foods and Veterinary
Medicine, Global Regulatory Operations and Policy, and Operations.
• FDA is responsible for protecting public health by:
-Safety -Dietary supplements
-Effectiveness -Regulating tobacco products
-Quality
-Security of Human
-Veterinary drugs
-Vaccines
-Other Biological products
-Medical devices
-Nation’s food supply
-All cosmetics
8. HEADQUARTERS
• The FDA has its headquarters at White Oak,Maryland.The
agency also has 223 field offices & 13 laboratories located
throughout the 50 states.
• In 2008,the FDA started opening offices in foreign countries
including China,India,Chile,Belgium & the United Kingdom.
9. US FDA-General Introduction
• U.S Department of Health & Human Services
Divisions of US FDA:
• Food
• Drugs
• Medical Devices
• Radiation-Emitting Products
• Vaccines,Blood & Biologics
• Animal & Veterinary
• Cosmetics
• Tobacco Products
10.
11.
12. FOOD PRODUCTS
Center for Food Safety & Applied Nutrition
• Monitoring of food supply
• Approval of new food addictives
• Monitors dietary supplements
13. DRUGS
• The Center for Drug Evaluation and Research involves regulation of three main
drug product types:
New drugs
Generic drugs
Over-the-counter drugs
• It covers more than just medicines.
E.g. Fluoride toothpaste, antiperspirants, dandruff shampoos and sunscreens are all
considered "drugs."
New drugs
New drugs receive extensive scrutiny before FDA approval in a process called
a New Drug Application (NDA).New drugs are available only by prescription by
default.
Generic drugs
Generic drugs are chemical equivalents of name-brand
Approval is done by Food and Drug Administration (FDA)
Over-the-counter (OTC) drugs
FDA has a list of approximately 800 approved ingredients that are combined in
various ways to create more than 100,000 OTC drug products.
14.
15.
16.
17.
18.
19.
20.
21.
22. Journey of new
chemical entity to
drug
Major departments involved in drug discovery
& development
24. DEFINITION OF A NEW DRUG
• Any chemical or substance not previously used in humans for the
treatment of a disease
• Combinations of approved drugs or of old drugs even though the
individual components are not new drugs
• An approved drug employed for uses other than those approved
• A new dosage form of an approved drug
• Even a drug used in vitro as a diagnostic agent when its uses will
influence the diagnosis or treatment of disease in a human patient
25. DRUG DISCOVERY & DEVELOPMENT
• Drug Discovery Phase:
- Selection of Active Pharmaceutical Ingredients(API)
- Lead compound identification & optimization(SAR)
• Product Development Phase:
-Pharmaceutical development
-Non-clinical development
-Clinical development
-Regulatory
29. • Investigational new drug application (IND), as described in
title 21 of the Code of Federal Regulations, part 312 (21 CFR
part 312) (the IND regulations). This guidance describes when
an IND is required, specific situations in which an IND is not
required, and a range of issues that, in FDA’s experience, have
been the source of confusion or misperceptions about the
application of the IND regulations. This guidance addresses
only whether an IND is needed. If your study also involves the
use of a device, you should determine whether such use is
subject to 21 CFR part 812 (the IDE regulations).
30. INVESTIGATIONAL NEW DRUG
APPLICATION (IND)
• The IND submitted to the FDA contains the results of all preclinical
investigations carried out in animals, including complete toxicity data,
the full pharmacologic spectrum of the drug and any studies of
absorption, distribution, biotransformation and excretion. In addition, the
IND must provide the following information:
– Copies of all informational material supplied to each
investigator (the data sheets supplied to the investigator
incorporate the data supplied in the IND itself)
– An agreement from the sponsor to notify FDA and all
investigators of any adverse effects that arise during either the
continuing animal studies or human tests
– Agreement to submit annual progress reports
– Certification that "informed consent" will be obtained from the
subjects or patients to whom the drug will be given
31. Summary of drug
discovery &
development
Approximate step wise duration for drug
discovery & development
32. PHASE I STUDIES
• Requires an FDA approved IND to commence .
• Conducted in normal healthy human volunteers
• Performed under carefully controlled conditions
• Toxicological and pharmacological data obtained by a
trained clinical pharmacologist
• Drug first administered at one tenth the ultimate projected
effective dose.
•Studies involve about 20 to 80 volunteers.
•Tests determine a drug's safety profile, including the safe
dosage ,absorbtion,distribution,metabolism and excretion and
duration of its action.
•Phase I trials take on the average 1 year.
33. PHASE II STUDIES
• Randomized control trials in patients with the disease for which the
drug is intended or as a pretreatment to prevent disease
• Trials involve 100 to 300 volunteer patients and are controlled in
design
• Doses are higher than those in Phase I
• Studies may last several months to two years
• Safety still an important concern, but efficacy is the major
emphasis
• Flexibility in the design of studies is very desirable at this stage
• Extremely slow metabolism of drug with accumulation of
subsequent doses and toxicity might require additional studies at
this point
•Changes in the original protocol require the submission of
amendments to IND and additional review by IRB’s
•This phase is designed to identify minimum and maximum doses.
•Phase II typically takes about 2 years.
34. PHASE III STUDIES
• Large-scale controlled studies
• Major objective is to develop data to permit the drug to be
marketed and used safely and effectively
• Multi-patient – multi-center study
• May involve as many as 150 clinicians, many of whom are
experienced clinical pharmacologists
• Usually involves 1500 to as many as 4000 patients
• Study generally lasts anywhere from 2 –10 years with an average
length of 5 years
• Study examines safety and effectiveness, but emphasizes proper
dose determination
• The following studies may be conducted at this stage:
– drug biotransformation
– capacity of drug to bind to plasma proteins
– to induce or inhibit enzymes
– to interact in various ways with other drugs
35. THE NEW DRUG APPLICATION (NDA)
• When the sponsor is convinced that the data obtained in Phase III
studies justify approval for safety and efficacy for the use(s)
intended, the NDA is submitted
• Usually, at least 5 years has elapsed since the drug was originally
screened
• The NDA contains all of the chemical, pharmacologic,
toxicologic., clinical and maufacturing data that have been
collected in the whole process
• The NDA also contains bioequivalence and bioavailability data
• If the NDA is deemed for some reason to be incomplete, the
sponsor is required to resubmit additional
• If there is a disagreement between FDA and the sponsor then a
hearing may be held and the outcome is appealable in Court
• Less than 25% of all new drugs for marketing are novel or new
molecular entities (NME’s). The rest are new salts, new
formulations, new indications or duplicates of drugs previously
approved for marketing
36. PHASE IV – POSTMARKETING
SURVEILLANCE
• Reports must include the following information about:
– quantity of drug distributed
– copies of mailing pieces and labeling
– examples of advertising for prescription drugs
• Immediate reports on unexpected side-effects, injury, toxic or
allergic reactions and failure of the drug to exert its expected
pharmacologic reaction
37. FDA Regulates…
Biologics:
• Vaccines
• Blood and blood products
• Cellular and gene therapy products
• Allergenic
Cosmetics including:
• color additives
• skin moisturizers and cleansers
• nail polish and perfume
38. Safe Blood Supply and Vaccine
Development
Biologics Evaluation and Research branch works on this..
Aims:
• Ensures safety of blood products supply and regulation of vaccine
products
• Addresses areas such as emergency operations, response to
emerging diseases, and updating of regulations.
• Vaccine approval
39. Cosmetics
• The two laws pertaining to Cosmetics are:
-Federal Food,Drug & Cosmetic Act
-Fair Packaging & Labelling Act
FDA intervene when necessary to protect the public but in general
does not require pre-market approval or testing.
What Can FDA Do if a Cosmetic Is Not Safe?
To prevent further shipment of a cosmetic that does not comply with the
law, FDA may
• Ask a federal court to issue an injunction
• Request to seize the products
• Initiate criminal action
• Refuse entry of an imported cosmetic
• Request that a company recall a product
40. Center for Devices and Radiological Health
deals with…..
Medical Devices:
• Simple items like tongue depressors
• Complex technologies such as heart pacemakers
• Surgical implants and prosthetics
Electronic Products that give off radiations:
• X-ray equipment
• Laser products
• Sunlamps
41. FDA also regulates…..
Veterinary Products including:
• livestock feeds
• veterinary drugs and devices
Tobacco Products:
• cigarette tobacco
• smokeless tobacco
42. GUIDANCE FOR BOTONICAL DRUGS
• This guidance explains when a botanical drug may be marketed under an
over-the-counter (OTC) drug monograph and when FDA regulations require
approval for marketing of a new drug application (NDA), submitted under
section 505(b) of the Federal Food, Drug, and Cosmetic Act (the Act), 21
U.S.C. 355(b).
• In addition, this document provides sponsors with guidance on submitting
investigational new drug applications (INDs) for botanical drug products,
including those botanical products (or botanicals) currently lawfully
marketed as foods (including conventional foods and dietary supplements)
in the United States.
• This guidance also discusses several areas in which, because of the unique
nature of botanicals, FDA finds it appropriate to apply regulatory policies
that differ from those applied to synthetic, semisynthetic, or otherwise
highly purified or chemically modified drugs (including antibiotics derived
from microorganisms).