The Food and Drug Administration (FDA) is organized into 8 centers that regulate specific products and conduct research. The centers are:
1. The Center for Biologics Evaluation and Research regulates vaccines, blood, and gene therapies.
2. The Center for Devices and Radiological Health oversees medical devices and radiation-emitting products.
3. The Center for Drug Evaluation and Research regulates prescription and over-the-counter drugs.
4. The Center for Food Safety and Applied Nutrition regulates food, dietary supplements, bottled water and cosmetics.
5. The Center for Tobacco Products regulates cigarettes and smokeless tobacco.
6. The Center for Veterinary Medicine regulates
overview of Japan pharmaceutical regulatory authority - PMDANandhanan
PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare.
Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
It conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety and also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare.
Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
It conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety and also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological 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.
overview of Japan pharmaceutical regulatory authority - PMDANandhanan
PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare.
Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
It conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety and also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare.
Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
It conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety and also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological 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.
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.
The slides explain 21 CFR Part 812. It includes all the guidelines to be followed by any manufacturer and investigator while manufacturing and investigating the safety, efficacy of the medical device.
Presentation at the Biosimilars and Follow-On Biologics 2014 Americas Conference, sponsored by Paradigm Global Events, February 12, 2014. Presentation focused on:
•Interchangeability
•State Substitution Laws
•Naming
•Risk Evaluation & Mitigation Strategies (REMS) and Their Impact on Biosimilars
•Where FDA Stands on Biosimilars
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.
The slides explain 21 CFR Part 812. It includes all the guidelines to be followed by any manufacturer and investigator while manufacturing and investigating the safety, efficacy of the medical device.
Presentation at the Biosimilars and Follow-On Biologics 2014 Americas Conference, sponsored by Paradigm Global Events, February 12, 2014. Presentation focused on:
•Interchangeability
•State Substitution Laws
•Naming
•Risk Evaluation & Mitigation Strategies (REMS) and Their Impact on Biosimilars
•Where FDA Stands on Biosimilars
Regulatory authorities (US-FDA, WHO and ICH)Sagar Savale
To promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner.
With respect to such products, protect the public health by ensuring that the food are safe, Wholesome, sanitary, and properly labelled; human and veterinary drugs are safe and effective; there is reasonable assurance of the safety and effectiveness of devices intended for human use; cosmetics are safe and properly labelled, and public health and safety are protected from the electronic product radiation.
Participates through appropriate process with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements.
Therapeutics Goods Administration(TGA) is a unit of the Australian Government Department of Health and Ageing, is responsible for administering the act.
How to Create Map Views in the Odoo 17 ERPCeline George
The map views are useful for providing a geographical representation of data. They allow users to visualize and analyze the data in a more intuitive manner.
Model Attribute Check Company Auto PropertyCeline George
In Odoo, the multi-company feature allows you to manage multiple companies within a single Odoo database instance. Each company can have its own configurations while still sharing common resources such as products, customers, and suppliers.
The Indian economy is classified into different sectors to simplify the analysis and understanding of economic activities. For Class 10, it's essential to grasp the sectors of the Indian economy, understand their characteristics, and recognize their importance. This guide will provide detailed notes on the Sectors of the Indian Economy Class 10, using specific long-tail keywords to enhance comprehension.
For more information, visit-www.vavaclasses.com
We all have good and bad thoughts from time to time and situation to situation. We are bombarded daily with spiraling thoughts(both negative and positive) creating all-consuming feel , making us difficult to manage with associated suffering. Good thoughts are like our Mob Signal (Positive thought) amidst noise(negative thought) in the atmosphere. Negative thoughts like noise outweigh positive thoughts. These thoughts often create unwanted confusion, trouble, stress and frustration in our mind as well as chaos in our physical world. Negative thoughts are also known as “distorted thinking”.
Instructions for Submissions thorugh G- Classroom.pptxJheel Barad
This presentation provides a briefing on how to upload submissions and documents in Google Classroom. It was prepared as part of an orientation for new Sainik School in-service teacher trainees. As a training officer, my goal is to ensure that you are comfortable and proficient with this essential tool for managing assignments and fostering student engagement.
Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
Students, digital devices and success - Andreas Schleicher - 27 May 2024..pptxEduSkills OECD
Andreas Schleicher presents at the OECD webinar ‘Digital devices in schools: detrimental distraction or secret to success?’ on 27 May 2024. The presentation was based on findings from PISA 2022 results and the webinar helped launch the PISA in Focus ‘Managing screen time: How to protect and equip students against distraction’ https://www.oecd-ilibrary.org/education/managing-screen-time_7c225af4-en and the OECD Education Policy Perspective ‘Students, digital devices and success’ can be found here - https://oe.cd/il/5yV
This is a presentation by Dada Robert in a Your Skill Boost masterclass organised by the Excellence Foundation for South Sudan (EFSS) on Saturday, the 25th and Sunday, the 26th of May 2024.
He discussed the concept of quality improvement, emphasizing its applicability to various aspects of life, including personal, project, and program improvements. He defined quality as doing the right thing at the right time in the right way to achieve the best possible results and discussed the concept of the "gap" between what we know and what we do, and how this gap represents the areas we need to improve. He explained the scientific approach to quality improvement, which involves systematic performance analysis, testing and learning, and implementing change ideas. He also highlighted the importance of client focus and a team approach to quality improvement.
The French Revolution, which began in 1789, was a period of radical social and political upheaval in France. It marked the decline of absolute monarchies, the rise of secular and democratic republics, and the eventual rise of Napoleon Bonaparte. This revolutionary period is crucial in understanding the transition from feudalism to modernity in Europe.
For more information, visit-www.vavaclasses.com
Home assignment II on Spectroscopy 2024 Answers.pdf
USFDA Over View
1. Presented By…..
Mr. Tarif Hussian
M.Pharm. (SEM-I)
Dept. of Pharmaceutical Sciences
Guided By…..
DR. Arun Nanda
Professor of Pharmaceutics
2. 2
Contents
● Introduction
● History
● Organization of FDA
The Center for Biologics Evaluation and Research (CBER)
The Center for Devices and Radiological Health (CDRH)
The Center for Drug Evaluation and Research (CDER)
The Center for Food Safety and Applied Nutrition (CFSAN)
Center for Tobacco Products
The Center for Veterinary Medicine (CVM)
The National Center for Toxicological Research (NCTR)
● Conclusion
c
3. 3
INTRODUCTION
The Food and Drug Administration (1930) is a federal agency of
the United States Department of Health and Human Services, one of
the United States federal executive departments.
Its headquarter located at White Oak, Maryland
The agency also has 223 field offices and13 laboratories located throughout the 50
states of USA.
Mission is to protecting consumers and promote public health .
FDA started opening office in foreign countries including China ,India, Costa Rica ,
Chile, Belgium and UK etc.
4. What does FDA regulate?
Foods, except for most meat and poultry products, which are regulated by the
U.S. Department of Agriculture.
Food additives
Infant formulas
Dietary supplements
Human drugs
Vaccines, blood products, and other biologics
Medical devices, from simple items like tongue depressors, to complex
technologies such as heart pacemakers.
Electronic products that give off radiation, such as microwave ovens and X-ray
equipment.
Cosmetics.
Feed, drugs, and devices used in pets, farm animals, and other animals.
Tobacco products
5. 5
FDA does not regulate
Advertising (except for prescription drugs, medical devices, and tobacco
products)
Alcoholic beverages
Some consumer products, such as paint, child- resistant packages, baby toys,
and household appliances (except for those that give off radiation)
Illegal drugs of abuse, such as heroin and marijuana.
Health insurance
Meat and poultry (except for game meats, such as venison, ostrich, and snake).
Restaurants and grocery stores.
What doesn’t FDA regulate ?
6. 1902 – Biologics Control Act
1906 – Pure Food and Drug 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
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
Note:-The FDA also enforces other laws, notably Section 361 of the Public Health Service Act
and associated regulations, many of which are not directly related to food or drugs.
HISTORY
7. 7
ORGANIZATION OF FDA
● FDA Commissioner :- Dr. Stephen M. Hahn
● The Office of Regulatory Affairs (ORA):- which conducts inspections
and enforces FDA regulations.
● The Center for Biologics Evaluation and Research (CBER):- which regulates products
such as vaccines, blood, and gene therapy.
● The Center for Devices and Radiological Health (CDRH):- Which regulates medical
devices ranging from thermometers to kidney dialysis machines, and electronic products that
give off radiation, such as microwave ovens.
● The Center for Drug Evaluation and Research (CDER):-which regulates over-the-counter
and prescription medications.
● The Center for Food Safety and Applied Nutrition (CFSAN):- which regulates most foods
(except meat and poultry, which are regulated by the U.S. Department of Agriculture).
● Center for Tobacco Products:- which regulates cigarettes, cigarette tobacco, roll-your-own
tobacco, and smokeless tobacco.
● The Center for Veterinary Medicine (CVM):- which regulates feed and drugs and devices
used in pets, farm animals, and other animals.
● The National Center for Toxicological Research (NCTR):- which supports FDA’s product
centers by providing innovative scientific technology, training, and technical expertise.
8. FDA ADVISORY COMMITTEE
8
Advisory committees provide FDA with independent advice from outside
experts on issues related to human and veterinary drugs, vaccines and
other biological products, medical devices, and food.
In general, advisory committees include a chair, several members, plus
a consumer, industry, and sometimes a patient representative.
Additional experts with special knowledge may be added for individual
committee meetings as needed.
Although the committees provide advice to the agency, FDA makes the
final decisions.
9. The Center for Biologics Evaluation
and
Research (CBER)
9
Biologic – a compound consisting or derived from, all or part of a living organism and used for
therapeutic or diagnostic purposes.
Examples of biological products include
● Vaccines blood and blood products ● Allergenic extracts
● Human cells and tissues used for transplantation (e.g. tendons, ligaments and bone)
● Gene therapies ● Cellular therapies
● Tests to screen potential blood donors for infectious agents such as HIV
Biologics License Applications (BLA) Process (CBER)
The Biologics License Application (BLA) is a request for permission to introduce, or deliver for
introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is
regulated under 21 CFR 600 – 680. Form 356h specifies the requirements for a BLA. This
includes:
Applicant information
Product/Manufacturing information
Pre-clinical studies
Clinical studies
Labeling
10. 10
BLA Submission
After 60 days
If application
filable
Approved
Refused
If safe and
effective for its
labeled indication
● CBER controls the regulatory oversight of biologics INDs.
● BLA submission and Review-
11. 11
Center for Devices and Radiological Health
(CDRH)
● Premarket approval of all medical devices
● Medical device includes products from the simple toothbrush to complex
devices such as implantable brain pacemakers
● Also oversees the safety performance of non-medical devices which emit
certain types of electromagnetic radiation
● Regulates following category of radiation emitting electronic products:-
Radiation
• Ionizing X-ray:- e.g. Dental radiography, Industrial X-ray etc.
• Optical (Visible, UV, IR, Laser):-e.g. Surgical laser, Germicide lamp etc.
• RF, Microwave, magnetic: - e.g. MRI, Microwave oven etc.
• Acoustic (Ultrasonic):- e.g. Ultrasonography, Hearing aids etc.
12. 12
Functions of CDRH- Benefits Risks Regulate firms who
manufacture , repackage , relabel or Import medical devices sold in US .
● Getting safe and effective devices to market as quickly as possible
while ensuring that devices currently on the market remain safe and
effective .
● minimizes human exposure to radiation from medical, occupational and
consumer products.
● Providing accurate, science-based information about the products.
● Prescribes and enforces GMPs and performance standards for radiation-
emitting electronic products and medical devices
● To recall defective or noncompliant products.
13. 13
Class I (General Controls) –
• are low risk product
• e.g.- manual surgical instruments, canes, patient scales, adhesive bandages etc.
• Manufacturers have to register their facilities, list the products they manufacture, and
comply with GMPs.
• are exempt from 510(k) pre-market clearance application submission.
Class II (Special Controls) –
• entail a moderate degree of risk
• e.g. ECG monitors, x-ray machines and endoscopes
• Have to produce adequate assurance of safety and effectiveness
• require submission of a 510(k) premarket notification to FDA
Class III (Premarket Approval) –
• entail significant risk to the patient
• e.g. implantable cardiac pacemakers, angioplasty catheters
• manufacturer must submit to the FDA a Premarket approval application (PMA )
Classification of medical devices according to
M.D. Amendments; 1976:
14. Center for Drug Evaluation and Research
(CDER)
● Acts as consumer watchdog in America’s healthcare system.
● Oversees the research, development, manufacture and marketing of
drugs.
● Ensures safety and efficacy of available drugs.
● regulates :
● Prescription drugs
● Generic drugs
● OTC drugs
● Also ensures truth in advertising for prescription drugs.
14
15. 15
The Center for Food Safety and Applied Nutrition
(CFSAN) Regulates –
food (except meat, poultry)
Dietary supplements
Bottled water and
cosmetic products.
The Food Safety Inspection Service (FSIS) in the U.S. Department of Agriculture
regulates meat and poultry products .
Ensures that food products are safe, sanitary, wholesome and honestly labeled.
Dietary supplements
The Dietary Supplement Health and Education Act (DSHEA) of 1994, created a new
regulatory framework for the safety and labeling of dietary supplements.
A dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to
supplement the diet.
A Dietary ingredient must be one or any combination of the following substances:
● a vitamin ● a mineral ● herb or other botanical ● an amino acid ● a dietary substance for
use by man to supplement the diet by increasing the total dietary intake (e.g., enzymes or tissues
from organs or glands) ● a concentrate, metabolite, constituent or extract.
16. 16
Under the Federal Food, Drug, and Cosmetic Act (FFDCA) they do
not require FDA approval before they go on the market(except- colour
additives)
FDA can only act after a cosmetic is on the market
The agency has ways to monitor these products, which are-
• Voluntary Cosmetic Registration Program(VCRP)
• Inspections
• Surveys of products
• Cosmetic Ingredient Review (CIR) expert panel
Also regulates labeling of cosmetics
Cosmetics Regulation
17. 17
It Came into force after Family Smoking Prevention and Tobacco
Control Act,2009
Authorizes FDA to-
• Require disclosure of tobacco product ingredients
• Create standards for tobacco products
• Restrict tobacco sales, distribution and marketing
• Require stronger health warning on packaging and in advertising
Restricts the access and attractiveness of cigarettes to kids
Bans the manufacture or sale of fruit or candy flavored cigarettes
Convenes the Center’s Tobacco Products Scientific Advisory Committee for
use of menthol in cigarettes, dissolvable tobacco products
Produces public information and education campaigns
Center For Tobacco Products
18. • Regulates food, food additives, and drugs that are given to animals(food animals, pets)
Primary focus –
1.on medications that are used in food animals.
2. assurance that they don’t affect human food supply
• Restricts the spread of bovine spongiform encephalopathy by doing inspections of
feed manufacturers
• New Animal Drug Application (NADA) submitted by sponsor
• Safety and efficacy of New Animal Drug Product should be assured before approval.
18
Center for Veterinary Sciences
(CVS)
19. • Research arm of FDA
• The research at NCTR supports FDA’s goals:
1) To understand critical biological events in the expression of toxicity,.
2) To develop and characterize methods, and incorporate new technologies
to improve the assessment of human exposure, susceptibility, and risk.
3) To increase the understanding of the interaction between genetics,
metabolism, and nutrition.
19
National Center for toxicological Research
(NCTR)