BUNDELKHAND UNIVERSITY, JHANSI

Submitted To :

Prof. S.K Prajapati

Professor and Head
Of Institute of Pharmacy
THIS POWERPOINT PRESENTATION
Bundelkhand University, IS PRESENTED BY THE STUDENTS OF
Jhansi B. PHARM (FINAL YEAR) GROUP- A

Dr. Suneel Kumar Niranjan

INSTITUTE OF PHARMACY
Assistant Professor BUNDELKHAND
Of Institute of Pharmacy
Bundelkhand University,
UNIVERSITY, JHANSI
Jhansi
United States Food
And Drug
Administration
(USFDA)
 Content
 Introduction and Establishment
 Regulatory Authority
 Laws and Regulations
 Regulatory Scope
 Approval Process
 Certification of USFDA
 Duties and Powers
 Responsibilities
 Headquarters
 Recent Developments
 Conclusion
 Introduction and Establishment

Overview :
The United States Food and Drug Administration (USFDA) is a federal agency within the U.S.
Department of Health and Human Services. Established to regulate and supervise food safety,
pharmaceuticals, medical devices, cosmetics, and tobacco products, it plays a pivotal role in
protecting and promoting public health.

Establishment :
The USFDA was founded in 1906, following the passage of the Pure Food and Drugs Act. This
landmark legislation was aimed at curbing the rampant problem of unsafe and mislabeled food
and pharmaceutical products in the market.
Introduction and Establishment

Mission :
The core mission of the USFDA is to safeguard
public health by ensuring the safety, efficacy, and
security of food, drugs, medical devices, and other
products. It does this through rigorous regulation,
scientific assessment, and enforcement of laws
designed to prevent harmful products from
reaching consumers. Essentially, the USFDA acts as
a gatekeeper, ensuring that only safe and effective
products make it to the market.
 Regulatory Authority
Key Acts and Laws :
The foundation of the USFDA's regulatory authority is built on several critical pieces of legislation:-
 Pure Food and Drugs Act (1906) : Laid the groundwork for the modern FDA by addressing issues of
food and drug safety.-
 Food, Drug, and Cosmetic Act (1938) : Expanded the FDA's authority to oversee the safety of food,
drugs, and cosmetics.-
 Federal Food, Drug, and Cosmetic Act (FFDCA) : Consolidated and expanded regulations from
previous acts, becoming the principal source of the FDA's legal authority.-
 Prescription Drug User Fee Act (PDUFA) : Allows the FDA to collect fees from drug manufacturers
to fund the new drug approval process, enhancing its capacity to review applications.
 Laws and Regulations
Two key components of these laws are:

1. Federal Food, Drug, and Cosmetic Act (FD&C Act): Passed in 1938, this is the
main law giving the FDA authority to regulate product safety, labelling, and marketing. It covers:
 Drug Approval : Ensures drugs are safe and effective before being sold.
 Food Safety : Establishes standards to prevent unsafe or mislabelled food.
 Cosmetic Regulation : Prevents the sale of unsafe or mislabelled cosmetics.
 Medical Devices : Classifies devices by risk and requires pre-market approval and post-market monitoring.

2. Code of Federal Regulations (CFR) : This is a detailed set of rules that explain how the
FDA enforces the FD&C Act. It includes: -
 Title 21 CFR : Covers drugs, food, medical devices, and cosmetics.
 Title 7 CFR : Regulates agricultural products and some aspects of food safety.
 Title 9 CFR : Governs animal and veterinary products.
 Title 42 CFR : Includes rules on public health, biologics, and controlled substances.
These laws and regulations are updated regularly to keep up with scientific and public health developments.
 Regulatory Scope
The USFDA's regulatory reach encompasses a vast array of products, ensuring comprehensive
public health protection:-
 Food : Ensures the safety and proper labelling of the food supply.
 Drugs : Oversees the approval and monitoring of prescription and over-the-counter
medications.
 Medical Devices : Regulates the development, testing, and distribution of medical devices.
 Biologics : Monitors biological products, such as vaccines and blood products, for safety and
efficacy.
 Veterinary Products : Regulates animal drugs, feeds, and devices.
 Cosmetics : Ensures the safety of cosmetics and personal care products.
 Radiation-Emitting Products : Oversees products that emit radiation, like X-ray machines.
 Tobacco Products : Controls the manufacture, distribution, and marketing of tobacco products
to protect public health.
 What USFDA Doesn’t Regulate
1. Advertising
2. Alcohol
3. Consumer Products
4. Drugs of Abuse
5. Health Insurance
6. Meat and Poultry
7. Pesticides
8. Restaurants and Grocery Stores
9. Water
 Approval Process
Drug Approval :
 New Drug Application (NDA) : This is a comprehensive document submitted by a
pharmaceutical company to the FDA, seeking approval to market a new drug. It includes data
from clinical trials, proposed labelling, and information on the drug's safety and efficacy.
 Investigational New Drug (IND) : Before beginning clinical trials, a company must submit an
IND application to the FDA, detailing the drug's composition and manufacturing process, and
providing preclinical study results.
 Abbreviated New Drug Application (ANDA) : For generic drugs, this application proves that
the generic is bioequivalent to the brand-name drug, without the need for extensive clinical
trials.
 Biologics License Application (BLA) : Similar to an NDA, but specifically for biologics, including
vaccines and blood products, demonstrating they meet FDA standards for safety, purity, and
potency.
 Approval Process
Medical Devices :
Classification : Devices are classified into three categories based on risk:

a. Class I : Low-risk devices (e.g., bandages).

b. Class II : Moderate-risk devices (e.g., infusion pumps).
c. Class III : High-risk devices (e.g., pacemakers).
Premarket Notification (510(k)) : Most Class II devices require a 510(k)
submission, demonstrating they are substantially equivalent to a legally
marketed device.
Premarket Approval (PMA) : Required for Class III devices, this process
involves rigorous evaluation of clinical data to ensure safety and efficacy.
 Approval Process

Food Safety :
 Food Additive Approval : Companies must
provide evidence that new food additives
are safe for consumption before they can be
used in products.
 Food Labelling : The FDA regulates the
labelling of food products to ensure
consumers have accurate information about
ingredients and nutritional content.
 Food Recalls : The FDA oversees the recall
process for contaminated or misbranded
food products to protect public health.
Certification of USFDA
 Duties and Powers
1. Product Approval : Reviews and approves new drugs, medical devices, vaccines, and biologics to
ensure they are safe and effective.
2. Food Safety : Sets and enforces food safety standards, inspects facilities, and ensures proper labelling
to prevent illnesses.
3. Cosmetic Regulation : Makes sure cosmetics are safe and correctly labelled, though they don’t need
pre-approval.
4. Tobacco Regulation : Oversees the production, marketing, and labelling of tobacco products to reduce
harm, especially for youth.
5. Biologics and Vaccines : Ensures vaccines, blood products, and biologics are safe and effective.
6. Medical Devices : Regulates medical devices by setting safety standards and approving them before
they hit the market.
7. Inspections and Enforcement : Inspects manufacturing facilities, enforces rules, and recalls unsafe
products.
8. Research and Data : Gathers data and conducts research to inform regulations and protect health.
9. Emergency Response : Issues Emergency Use Authorizations (EUAs) during health crises to speed up
the availability of critical medical products.
[Link] powers : Issues emergency use Authorization (EUAs) during health crisis to speed up
access to treatments and vaccines.
 Responsibilities

 Protecting the public health by assuring that foods are safe, wholesome, sanitary and properly
labelled; 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 labelled Regulating tobacco
products.
 Helping the public get the accurate science-based information they need to use medicines,
devices, and foods to improve their health.
 Headquarters
1. CDER (Center for Drug Evaluation and Research) : Regulates pharmaceutical drugs and
biologic therapies.
2. CDRH (Center for Devices and Radiological Health) : Oversees medical devices and
products that emit radiation.
3. CBER (Center for Biologics Evaluation and Research) : Manages vaccines, blood products,
and other biologics.
4. CFSAN (Center for Food Safety and Applied Nutrition) : Focuses on food safety, nutrition,
and dietary supplements.
5. CVM (Center for Veterinary Medicine) : Regulates animal drugs, food for animals, and
veterinary devices.
6. ORA (Office of Regulatory Affairs) : Conducts inspections, enforces regulations, and ensures
compliance to maintain product quality and safety.
7. OC (Office of the Commissioner) : Provides leadership and sets policies for the FDA.
Headquarters
8. OGROP (Office of Global Regulatory Operations
and Policy) : Handles international relations and
develops global regulatory policies.

9. OMHHE (Office of Minority Health and Health

Equity) : Works to reduce health disparities
among minority groups.

10. OWH (Office of Women's Health) : Promotes

research and policies specifically related to
women’s health issues.

These offices and centers work together to ensure

the safety and quality of products available to the
public, making the FDA headquarters a vital hub for
regulatory activity and decision-making in the U.S.
 Recent Developments
Recent developments in the U.S. Food and Drug Administration (FDA) include advancements
in drug approvals, regulatory frameworks, and efforts to enhance public health. Here are
some notable trends and changes:
Accelerated Drug Approvals :
i. Gene Therapies: The FDA has been actively approving gene therapies to treat rare
diseases, like spinal muscular atrophy and hemophilia.
ii. Breakthrough Designations: The FDA has expanded the use of its Breakthrough Therapy
Designation, providing a faster path to approval for drugs addressing serious conditions.

COVID-19 Response :
 The FDA has played a significant role in the approval of COVID-19 vaccines (like Pfizer-
BioNTech and Moderna) and antivirals. Emergency Use Authorizations (EUAs) were crucial
in expediting access to vaccines and treatments during the pandemic.
 Ongoing evaluations of booster vaccines and treatments for emerging variants continue.
 Recent Developments
Focus on Digital Health :
The FDA has accelerated the regulation of digital health tools, such as mobile health apps,
wearables, and software as a medical device (SaMD). They have also been promoting the use of
Artificial Intelligence (AI) in medical diagnostics.
Real-World Evidence (RWE) :
To improve decision-making processes, the FDA has emphasized Real-World Data (RWD) and
Real-World Evidence in post-market surveillance and drug approvals.
Regulatory Overhaul for Medical Devices :
 The FDA has been modernizing its approach to medical device regulation, especially for AI-
powered diagnostics and robotics in surgery.
 Efforts are underway to improve post-market surveillance of medical devices, enhancing
patient safety.
 Recent Developments
Opioid Crisis Initiatives :
The FDA has introduced stringent guidelines to control the misuse of opioids, including stricter
label warnings, post-marketing requirements for opioid manufacturers, and promoting abuse-
deterrent formulations.
Food Safety Modernization :
The FDA continues to strengthen food safety measures, including guidelines for food traceability,
improving inspection processes, and combating foodborne illnesses.
Focus on Rare Diseases :
Recent years have seen an increase in FDA approvals for orphan drugs. The Orphan Drug Act
continues to incentivize pharmaceutical companies to develop treatments for rare diseases.
 Conclusion
Summary :
The USFDA plays a crucial role in safeguarding public health through the regulation of food, drugs,
medical devices, and more. Established in 1906, its structure includes specialized centers for
focused oversight. Its regulatory authority is based on key acts like the Pure Food and Drugs Act and
the Food, Drug, and Cosmetic Act, covering a wide range of products. Approval processes for drugs,
medical devices, and food safety involve rigorous evaluation to ensure safety and efficacy. The
agency enforces compliance through inspections and recalls, and it adapts to new challenges with
updated policies and technological advancements.

Future Outlook :
The FDA will continue to be pivotal in ensuring public health and safety. As new technologies and
medical advancements emerge, the agency will need to adapt and evolve its regulatory framework.
This includes embracing digital health technologies, personalized medicine, and innovative
manufacturing processes. The FDA's ongoing commitment to protecting consumers and promoting
public health will be essential in navigating the complexities of the future healthcare landscape.
 Our Team Members

Abdul Wahid Akash Yadav

Abhimanyu Singh Akriti Singh

Abhishek Akshay Dubey

Aditi Srivastava Aman Singh

Ajit Chaudhari Ankit Kumar Singh

THANK YOU