This document provides an overview of the US Food and Drug Administration (FDA) in 3 paragraphs. It discusses that the FDA was formed in 1906 and is responsible for regulating foods, drugs, medical devices, and other products. It describes the FDA's structure and responsibilities across its centers and offices. The document also provides brief summaries of the FDA approval processes for drugs, medical devices, and food products.
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
Intellectual Property Rights (IPRs) are legal rights that protect creations and/or inventions resulting from intellectual activity in the industrial, scientific, literary, or artistic fields. The most common IPRs include patents, copyrights, marks, and trade secrets and Regulatory affair is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics, and complementary medicines, and by the companies
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.
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
Intellectual Property Rights (IPRs) are legal rights that protect creations and/or inventions resulting from intellectual activity in the industrial, scientific, literary, or artistic fields. The most common IPRs include patents, copyrights, marks, and trade secrets and Regulatory affair is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics, and complementary medicines, and by the companies
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.
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...Swapnil Fernandes
- European pharmaceutical legislation provides a comprehensive framework for the marketing authorisation of vaccines.
- In contrast to the European scenario, the Indian scenario for vaccines is relatively less regulated and follows the same process of approval as other biologics in spite of having a National Handbook for Vaccine Policy.
- Vaccine authorisation in the US, as is the case in EU, is a more straightforward process than in most other markets as the USFDA has provided vaccines with a distinct set of regulations in concerned areas of safety and quality.
Herbal medicines are popular because of experience and the abundant
availability of plants in India due to its varied climatic zones. India has
around 45,000 species of plants, out of which 15,000–20,000 plants have
proven medicinal value.
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.
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...Swapnil Fernandes
- European pharmaceutical legislation provides a comprehensive framework for the marketing authorisation of vaccines.
- In contrast to the European scenario, the Indian scenario for vaccines is relatively less regulated and follows the same process of approval as other biologics in spite of having a National Handbook for Vaccine Policy.
- Vaccine authorisation in the US, as is the case in EU, is a more straightforward process than in most other markets as the USFDA has provided vaccines with a distinct set of regulations in concerned areas of safety and quality.
Herbal medicines are popular because of experience and the abundant
availability of plants in India due to its varied climatic zones. India has
around 45,000 species of plants, out of which 15,000–20,000 plants have
proven medicinal value.
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.
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.
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Unveiling the Secrets How Does Generative AI Work.pdfSam H
At its core, generative artificial intelligence relies on the concept of generative models, which serve as engines that churn out entirely new data resembling their training data. It is like a sculptor who has studied so many forms found in nature and then uses this knowledge to create sculptures from his imagination that have never been seen before anywhere else. If taken to cyberspace, gans work almost the same way.
Putting the SPARK into Virtual Training.pptxCynthia Clay
This 60-minute webinar, sponsored by Adobe, was delivered for the Training Mag Network. It explored the five elements of SPARK: Storytelling, Purpose, Action, Relationships, and Kudos. Knowing how to tell a well-structured story is key to building long-term memory. Stating a clear purpose that doesn't take away from the discovery learning process is critical. Ensuring that people move from theory to practical application is imperative. Creating strong social learning is the key to commitment and engagement. Validating and affirming participants' comments is the way to create a positive learning environment.
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Sustainability has become an increasingly critical topic as the world recognizes the need to protect our planet and its resources for future generations. Sustainability means meeting our current needs without compromising the ability of future generations to meet theirs. It involves long-term planning and consideration of the consequences of our actions. The goal is to create strategies that ensure the long-term viability of People, Planet, and Profit.
Leading companies such as Nike, Toyota, and Siemens are prioritizing sustainable innovation in their business models, setting an example for others to follow. In this Sustainability training presentation, you will learn key concepts, principles, and practices of sustainability applicable across industries. This training aims to create awareness and educate employees, senior executives, consultants, and other key stakeholders, including investors, policymakers, and supply chain partners, on the importance and implementation of sustainability.
LEARNING OBJECTIVES
1. Develop a comprehensive understanding of the fundamental principles and concepts that form the foundation of sustainability within corporate environments.
2. Explore the sustainability implementation model, focusing on effective measures and reporting strategies to track and communicate sustainability efforts.
3. Identify and define best practices and critical success factors essential for achieving sustainability goals within organizations.
CONTENTS
1. Introduction and Key Concepts of Sustainability
2. Principles and Practices of Sustainability
3. Measures and Reporting in Sustainability
4. Sustainability Implementation & Best Practices
To download the complete presentation, visit: https://www.oeconsulting.com.sg/training-presentations
Business Valuation Principles for EntrepreneursBen Wann
This insightful presentation is designed to equip entrepreneurs with the essential knowledge and tools needed to accurately value their businesses. Understanding business valuation is crucial for making informed decisions, whether you're seeking investment, planning to sell, or simply want to gauge your company's worth.
India Orthopedic Devices Market: Unlocking Growth Secrets, Trends and Develop...Kumar Satyam
According to TechSci Research report, “India Orthopedic Devices Market -Industry Size, Share, Trends, Competition Forecast & Opportunities, 2030”, the India Orthopedic Devices Market stood at USD 1,280.54 Million in 2024 and is anticipated to grow with a CAGR of 7.84% in the forecast period, 2026-2030F. The India Orthopedic Devices Market is being driven by several factors. The most prominent ones include an increase in the elderly population, who are more prone to orthopedic conditions such as osteoporosis and arthritis. Moreover, the rise in sports injuries and road accidents are also contributing to the demand for orthopedic devices. Advances in technology and the introduction of innovative implants and prosthetics have further propelled the market growth. Additionally, government initiatives aimed at improving healthcare infrastructure and the increasing prevalence of lifestyle diseases have led to an upward trend in orthopedic surgeries, thereby fueling the market demand for these devices.
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Memorandum Of Association Constitution of Company.pptseri bangash
www.seribangash.com
A Memorandum of Association (MOA) is a legal document that outlines the fundamental principles and objectives upon which a company operates. It serves as the company's charter or constitution and defines the scope of its activities. Here's a detailed note on the MOA:
Contents of Memorandum of Association:
Name Clause: This clause states the name of the company, which should end with words like "Limited" or "Ltd." for a public limited company and "Private Limited" or "Pvt. Ltd." for a private limited company.
https://seribangash.com/article-of-association-is-legal-doc-of-company/
Registered Office Clause: It specifies the location where the company's registered office is situated. This office is where all official communications and notices are sent.
Objective Clause: This clause delineates the main objectives for which the company is formed. It's important to define these objectives clearly, as the company cannot undertake activities beyond those mentioned in this clause.
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Liability Clause: It outlines the extent of liability of the company's members. In the case of companies limited by shares, the liability of members is limited to the amount unpaid on their shares. For companies limited by guarantee, members' liability is limited to the amount they undertake to contribute if the company is wound up.
https://seribangash.com/promotors-is-person-conceived-formation-company/
Capital Clause: This clause specifies the authorized capital of the company, i.e., the maximum amount of share capital the company is authorized to issue. It also mentions the division of this capital into shares and their respective nominal value.
Association Clause: It simply states that the subscribers wish to form a company and agree to become members of it, in accordance with the terms of the MOA.
Importance of Memorandum of Association:
Legal Requirement: The MOA is a legal requirement for the formation of a company. It must be filed with the Registrar of Companies during the incorporation process.
Constitutional Document: It serves as the company's constitutional document, defining its scope, powers, and limitations.
Protection of Members: It protects the interests of the company's members by clearly defining the objectives and limiting their liability.
External Communication: It provides clarity to external parties, such as investors, creditors, and regulatory authorities, regarding the company's objectives and powers.
https://seribangash.com/difference-public-and-private-company-law/
Binding Authority: The company and its members are bound by the provisions of the MOA. Any action taken beyond its scope may be considered ultra vires (beyond the powers) of the company and therefore void.
Amendment of MOA:
While the MOA lays down the company's fundamental principles, it is not entirely immutable. It can be amended, but only under specific circumstances and in compliance with legal procedures. Amendments typically require shareholder
RMD24 | Retail media: hoe zet je dit in als je geen AH of Unilever bent? Heid...BBPMedia1
Grote partijen zijn al een tijdje onderweg met retail media. Ondertussen worden in dit domein ook de kansen zichtbaar voor andere spelers in de markt. Maar met die kansen ontstaan ook vragen: Zelf retail media worden of erop adverteren? In welke fase van de funnel past het en hoe integreer je het in een mediaplan? Wat is nu precies het verschil met marketplaces en Programmatic ads? In dit half uur beslechten we de dilemma's en krijg je antwoorden op wanneer het voor jou tijd is om de volgende stap te zetten.
Cracking the Workplace Discipline Code Main.pptxWorkforce Group
Cultivating and maintaining discipline within teams is a critical differentiator for successful organisations.
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• Four (4) workplace discipline methods you should consider
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RMD24 | Debunking the non-endemic revenue myth Marvin Vacquier Droop | First ...BBPMedia1
Marvin neemt je in deze presentatie mee in de voordelen van non-endemic advertising op retail media netwerken. Hij brengt ook de uitdagingen in beeld die de markt op dit moment heeft op het gebied van retail media voor niet-leveranciers.
Retail media wordt gezien als het nieuwe advertising-medium en ook mediabureaus richten massaal retail media-afdelingen op. Merken die niet in de betreffende winkel liggen staan ook nog niet in de rij om op de retail media netwerken te adverteren. Marvin belicht de uitdagingen die er zijn om echt aansluiting te vinden op die markt van non-endemic advertising.
1. school of pharmaceutical science
(sops, utd-rgpv, Bhopal (m.p.)
Prepared Bysana iram
M.PHARM (Q.A)
1st sem.
2.
Mission, vision and organistional structure of USFDA
U.S Federal partners
Responsibility
Act and Regulations
Overview of guidelines
R & D process
IND, NDA and ANDA
US FDA preperation
References
3.
Formed
◦
◦
◦
◦
1906
Preceding agencies
Food, Drug, and Insecticide Administration (July 1927 to July 1930)
Bureau of Chemistry, USDA (July 1901 through July 1927)
Division of Chemistry, USDA (established 1862)
Jurisdiction
Federal government of the United States
Headquarters
White Oak Campus, 10903 New Hampshire Avenue, Silver Spring,
Maryland 20993 39°02′07″N 76°58′59″W
Employees
9,300
Annual budget
$4.36 billion
Agency executive
Dr. Margaret Hamburg, Commissioner of Food and Drugs
[3]
Parent Agency
Department of Health and Human Services
Child agencies
Center for Biologics Evaluation and Research
Center for Devices and Radiological Health
Center for Drug Evaluation and Research
Center for Food Safety and Applied Nutrition
Center for Tobacco Products
Center for Veterinary Medicine
National Center for Toxicological Research
Office of Criminal Investigations
Office of Regulatory Affairs
Website
www.fda.gov
Laboratories Thirteen
States
Fifty
4.
The Food and Drug Administration (FDA or
USFDA) is an agency of the United States
Department of Health and Human Services
and is responsible for regulating and
supervising the safety of foods, dietary
supplements, drugs, vaccines, biological
medical products, blood products, medical
devices, radiation-emitting devices,
veterinary products, and cosmetics.
5. 1902 – Biologics Control Act
1906 – Pure Food and Drug Act
1938 – Federal Food, Drug, and Cosmetic Act
1944 – Public Health Service Act
1951 – Food, Drug, and Cosmetics Act
Amendments
1962 – Food, Drug, and Cosmetics Act
Amendments
1966 – Fair Packaging and Labeling Act
1976 – Medical Device Regulation Act
1987 – Prescription Drug Marketing Act
5
6. 1988 – Anti–drug Abuse Act
1990 – Nutrition Labeling and Education Act
1992 – Prescription Drug User Fee Act
1994 – Dietary Supplement Health and
Education Act
1997 – Food and Drug Modernization Act
2002 – Bioterrorism Act
2002 – Medical Device User Fee and
Modernization Act (MDUFMA)
2003 – Animal Drug User Fee Act
2007 – Food and Drug Administration
Amendments Act of 2007
6
7.
Public demands action
Congress enacts general law
FDA proposes science-based regulations to put the law
into effect
Regulations are notified, finalized and published in 21
Code of Federal Regulations (CFR)
FDA assures compliance by enforcement and inspections
that are targeted by risk assessment
Industry has the ultimate responsibility to produce safe
foods
7
8. FDA regulates interstate commerce
Transparency
Same standards for domestic and international
Science-based regulations
Consistency and predictability of implementation
8
9. Department of Health and Human Services (HHS)
◦ Food and Drug Administration (FDA)
◦ Centers for Disease Control and Prevention (CDC)
Department of Agriculture (USDA)
◦ Food Safety and Inspection Service (FSIS)
◦ Animal and Plant Health Inspection Service (APHIS)
◦ Foreign Agricultural Service (FAS)
Environmental Protection Agency (EPA)
Bureau of Customs and Border Protection (CBP)
Alcohol and Tobacco Tax and Trade Bureau (TTB)
9
10.
Protecting the public health by assuring that foods are safe,
wholesome, sanitary and properly labeled; human and
veterinary drugs, and vaccines and other biological products
and medical devices intended for human use are safe and
effective
Protecting the public from electronic product radiation
Assuring cosmetics and dietary supplements are safe and
properly labeled
Regulating tobacco products
Advancing the public health by helping to speed product
innovations
Helping the public get the accurate science-based information
they need to use medicines, devices, and foods to improve
their health
FDA’s responsibilities extend to the 50 United States, the
District of Columbia, Puerto Rico, Guam, the Virgin Islands,
American Samoa, and other U.S. territories and possessions.
11.
The Office of the Commissioner (OC)
The Center for Drug Evaluation and Research (CDER)
The Center for Biologics Evaluation and Research (CBER)
The Center for Food Safety and Applied Nutrition (CFSAN)
The Center for Devices and Radiological Health (CDRH)
The Center for Veterinary Medicine (CVM)
The National Center for Toxicological Research (NCTR)
The Office of Regulatory Affairs (ORA)
The Office of Criminal Investigations (OCI)
12. Component
Full Form
Regulates
CBER
Center For Biologics Evaluation
And Research
Biological Products.
CDRH
Center For Devices And
Radiological Health
Safety and Effectiveness of New
Medical Devices Before Marketed.
CDER
Center For Drug Evaluation And
Research
Health of by Assuring Prescription
and OTC Drugs are Safe and
Effective.
CSFAN
Center For Food Safety And
Applied Nutrition
Food Supply is Safe, Sanitary,
Wholesome, and Honestly Labeled, and
Cosmetic Products are Safe and
Properly Labeled.
CVM
Center For Veterinary Medicine
Assure that Animal Food Products
are Safe.
NCTR
National Center For Toxicological
Research
Human Toxicity.
OC
Office Of The Commissioner
………………
ORA
Office Of Regulatory Affairs
Products Comply with Appropriate Public
Health Laws and Regulations.
13.
Food
Drugs
Medical Devices *
Biologics
Animal Feed and Drugs
Cosmetics
Radiation-Emitting
Products *
Combination Products
(drug-device*, biologicdevice*, drug-biologic)
*
CDRH
Center for Devices
and Radiological Health
CDER
Center for Drugs and
Evaluation Research
CBER
Center for Biologics and
Evaluation Research
FDA
CVM
Center for
Veterinary Medicine
CFSAN
Center for Food Safety
and Applied Nutrition
NCTR
National Center
for Toxicological Research
15.
Foods
◦ safety of all food products
(except for most meat and poultry products, which are regulated by the
U.S. Department of Agriculture)
◦ labeling
◦ bottled water
◦ food additives
◦ infant formulas
Dietary Supplements
Human Drugs
◦
◦
◦
◦
◦
◦
◦
product approvals
OTC and prescription drug labeling
drug manufacturing standards
Vaccines, Blood Products, and Other Biologics
product and manufacturing establishment licensing
safety of the nation's blood supply
research to establish product standards and develop improved testing
methods
16.
Medical Devices
from simple items like tongue depressors, to complex technologies such as heart
pacemakers
premarket approval of new devices
manufacturing and performance standards
tracking reports of device malfunctioning and serious adverse reactions
Electronic Products
products that give off radiation, such as microwave ovens and X-ray equipment
radiation safety performance standards for microwave ovens, television receivers,
diagnostic
x-ray equipment, cabinet x-ray systems (such as baggage x-rays at airports), laser
products,
ultrasonic therapy equipment, mercury vapor lamps, and sunlamps
accrediting and inspecting mammography facilities
Cosmetics
safety
labeling
Veterinary Products
livestock feeds
pet foods
veterinary drugs and devices
veterinary biologics not regulated by USDA are considered new animal drugs
Tobacco Products
17. CFR Title 21 (Code Of Federal Regulation)
- Food and Drugs: Parts 1 to 1499 different
types of parts to food, drug , cosmetic and
medical devices and etc
For Conducting a clinical research on IND
different imp parts is their
18. 21 CFR part 11- Electronic submission and Electronic
signature
21 CFR part 50- Protection of human subjects
21 CFR part 54- Financial Disclosure by Clinical
Investigators
21 CFR part 56- Institutional Review Board
21 CFR part 312- Investigational new drug application
21 CFR part 314- Application for FDA Approval to
Market a New Drug
19.
20. Foods are safe, wholesome and sanitary;
Human and veterinary drugs and medical
devices are safe and effective;
Human biologics are safe and effective;
Cosmetics are safe;
Electronic products that emit radiation are safe;
and
Labeling for these products honestly represents
them to users, and their instructions for use are
adequate.
21. Development
Preclinical studies
Early Clinical
Development
CHEMISTRY/
PHARMACOLOGY
IND*
PHASE I
PHASE II
PHASE III
NDA**
PHASE IV
Search for
active
substances
Regulatory
review
Efficacy
studies on
healthy
volunteers
Clinical
studies on a
limited scale
Regulatory
review
Continued
comparative
studies
50–150
persons
100–200
patients
Comparativ
e studies on
a large
number of
patients
20/12/13
Discovery
Clinical studies
*Investigational
New Drug
Application for
permission to
administer a new
drug to humans
Toxicology,
efficacy
studies on
various types
of animals KNOWLEDGE
LEVEL
500–5,000
patients
LEVEL
KNOWLEDGE
Registration,
market
introduction
**New Drug
Application
Application for
permission to market
a new drug
TIME SPAN
2–4 yrs.
2–6 months
3–6 yrs.
1–3 yrs.
Approximately 10–15 years from idea to marketable drug
21
22.
23.
24. (NDA) Requirements
(ANDA) Requirements
1. Labeling
1. Labeling
2. Pharm / Tox
2. Pharm / Tox
3. Chemistry 3. Chemistry
4. Manufacturing
4. Manufacturing
5. Controls
5. Controls
6. Microbiology
6. Microbiology
7. Inspection 7. Inspection
8. Testing
8. Testing
9. Animal Studies
10. Clinical Studies
9. Bioequivalence
11. Bioavailability
Labeling
◦ “Same” information as brand name labeling
◦ May delete portions of labeling protected by patent or exclusivity (i.e., an
indication, strength)
◦ May differ in excipients and product description (i.e., colors, shapes)
25.
FDA inspects manufacturers or processors of FDA-regulated products
to verify that they comply with relevant regulations. Those inspected
include
vaccine and drug manufacturers
blood banks
food processing facilities
dairy farms
animal feed processors
FDA also inspects
facilities that conduct studies in people (clinical trials)
laboratories that conduct studies in animals or microorganisms when
these studies are used to apply for FDA approval of a medical product
foreign manufacturing and processing sites for FDA-regulated products
that are sold in the United States
imported products at the border
31.
Register facility with FDA
Register process for canning/aseptic packaging of
Low Acid/Acidified Canned Foods (LACF)
Use good practices in food production
◦ Agricultural
◦ Aquacultural
◦ Manufacturing
◦ HACCP
Assure that the product is safe, wholesome, sanitary,
properly packaged and labeled
Give “Prior Notice”
31
32. 1.
2.
3.
4.
5.
6.
Drugs and Cosmetic Act, 1940, Govt. of India
Drugs and Cosmetic Rules, 1945, Govt. of
India.
Office of Generic Drugs Home Page:
ttp://www.fda.gov/cder/ogd/index.htm
On line training program:
http://www.fda.gov/cder/learn/CDERLearn/gen
DrugProcess/transcript.htm
http://www.fda.gov/cder/orange/default.htm
www.cdsco.nic.in
Editor's Notes
Origins
The U S. Food and Drug Administration is a scientific, regulatory, and public health agency that oversees items accounting for 25 cents of every dollar spent by consumers. Its jurisdiction encompasses most food products (other than meat and poultry), human and animal drugs, therapeutic agents of biological origin, medical devices, radiation-emitting products for consumer, medical, and occupational use, cosmetics, and animal feed. The agency grew from a single chemist in the U.S. Department of Agriculture in 1862 to a staff of approximately 9,100 employees and a budget of $1.294 billion in 2001, comprising chemists, pharmacologists, physicians, microbiologists, veterinarians, pharmacists, lawyers, and many others. About one-third of the agency's employees are stationed outside of the Washington, D. C. area, staffing over 150 field offices and laboratories, including five regional offices and 20 district offices. Agency scientists evaluate applications for new human drugs and biologics, complex medical devices, food and color additives, infant formulas, and animal drugs. Also, the FDA monitors the manufacture, import, transport, storage, and sale of about $1 trillion worth of products annually at a cost to taxpayers of about $3 per person. Investigators and inspectors visit more than 16,000 facilities a year, and arrange with state governments to help increase the number of facilities checked.
HISTORY
The legislation having failed to develop, the Secretary of HEW commissioned the Study Group on Medical Devices, which recommended in 1970 that medical devices be classified according to their comparative risk, and regulated accordingly. The 1976 Medical Device Amendments, coming on the heels of a therapeutic disaster in which thousands of women were injured by the Dalkon Shield intrauterine device, provided for three classes of medical devices, each requiring a different level of regulatory scrutiny--up to pre-market approval.
1976
MEDICAL DEVICE AMENDMENTS passed to ensure safety and effectiveness of medical devices, including diagnostic products. The amendments require manufacturers to register with FDA and follow quality control procedures. Some products must have pre-market approval by FDA; others must meet performance standards before marketing.
TOTAL PRODUCT LIFE CYCLE MODEL (TPLC) is applied across Center activities to promote and protect the public heath.
Total Product Life Cycle (TPLC) is an integrated product development scheme and a conceptual framework for assessing a variety of industrial and clinical models. For the manufacturer TPLC is the market-driven evolution of a device, drug, or biologic from initial conception, through pre-market development, to widespread market use, and finally to obsolescence and replacement by subsequent generations of products.
There are various ways of illustrating the R&D process – this is one. We see, among other things, how knowledge about a drug increases during the course of the process, but that upon market introduction, there is still a great deal to be learned about how the drug works in the body. Developing a new drug is a complex and costly process.
If everything goes according to plan, a new drug will be ready approximately ten years after the work was first begun. We are working to shorten this time to eight years.
Pharmaceutical companies are constantly striving to shorten the time from idea to finished pharmaceutical product. At the same time, the demands on documentation continue to rise.
Lets look at where these inspections have taken place. Almost a third of them have been in the U.S., which makes sense. But there is also plenty of presence by the FDA in India, Italy, and China and that is expected to increase over coming years.