FDA
Abdulmohaimen Altaie
FDA(Food and Drug Adminstration)
The Food and Drug Administration (FDA) is the regulatory authority
responsible for protecting and promoting public health by controlling and
supervising the safety of foods, dietary supplements, prescription and over-
the-counter medications, vaccines, biopharmaceuticals, blood transfusions,
radiation-emitting devices, veterinary products, and other responsibilities.
Here are some key areas the FDA
regulates:
• Pharmaceuticals: The FDA oversees the
development, testing, and approval of prescription and
over-the-counter medications, ensuring that they are
safe and effective for use.
• Biological Products: This includes vaccines, blood
and blood products, gene therapies, and other
biopharmaceuticals. The FDA plays a crucial role in
evaluating and approving these products to protect
public health.
• Medical Devices: From simple tools like bandages to
complex technologies such as pacemakers and
diagnostic equipment, the FDA regulates a diverse
array of medical devices to guarantee their safety and
effectiveness.
• Food and Beverages: The FDA is responsible for ensuring the safety of the U.S. food supply. This
includes everything from raw agricultural products to packaged foods and beverages.
• Dietary Supplements: The FDA oversees the safety and labeling of dietary supplements, including
vitamins, minerals, and herbal products.
• Cosmetics: While the FDA does not pre-approve cosmetics, it monitors and regulates these products to
ensure they are safe for use.
• Tobacco Products: The FDA regulates tobacco products, including cigarettes, smokeless tobacco, and
e-cigarettes, with the goal of reducing the public health impact of tobacco use.
• Radiation-Emitting Devices: This category includes X-ray machines, microwave ovens, and other
devices that emit radiation. The FDA ensures their safety and effectiveness.
• Animal and Veterinary Products: The FDA regulates products used in the treatment and care of
animals, including veterinary drugs and animal food.
• Blood Transfusions and Transplantation: The FDA oversees the safety of blood and blood
products, as well as organ transplantation to prevent transmission of diseases.
Drug Approval Process
Discovery and Development:
Drug development often begins with laboratory research to identify
potential compounds that may have therapeutic effects.
Promising compounds are then subjected to preclinical testing in
the laboratory and on animals to assess their safety and
effectiveness.
Investigational New Drug (IND) Application:
If preclinical testing shows promise, a pharmaceutical company
submits an Investigational New Drug (IND) application to the FDA.
The IND contains data from the preclinical studies and outlines the
company's plan for testing the drug in humans.
Clinical Trials - Phase I:
Phase I trials involve a small number of healthy volunteers to assess
the drug's safety, dosage range, and potential side effects.
The focus is on understanding how the drug behaves in the human
body.
Clinical Trials - Phase II:
Phase II trials expand the study to a larger group of patients to further
evaluate safety and begin assessing effectiveness.
These trials provide additional information on the drug's side effects
and potential risks.
Clinical Trials - Phase III:
Phase III trials involve a larger population and further assess the drug's
effectiveness, monitor side effects, and compare it to standard
treatments.
These trials provide more comprehensive data on the drug's benefits
and risks.
New Drug Application (NDA):
If the results of the clinical trials are positive, the
pharmaceutical company submits a New Drug Application
(NDA) to the FDA.
The NDA includes all data from preclinical testing and the
three phases of clinical trials.
FDA Review:
The FDA reviews the NDA to ensure the drug's safety,
efficacy, and manufacturing standards.
This review involves teams of medical, statistical, and
regulatory experts.
Advisory Committee Review:
In some cases, an FDA advisory committee of external
experts may be convened to review the data and provide
recommendations.
FDA Decision:
Based on the review and any advisory committee
recommendations, the FDA decides whether to approve or
reject the drug.
If approved, the drug can be marketed and distributed.
Post-Market Surveillance:
After approval, the FDA continues to monitor the drug's
safety through post-market surveillance, and additional
studies may be required.
THANK YOU
References
https://www.fda.gov
