Assignment

Information of Food and Drug Administration (FDA)

Department of Pharmacy
Course Title: Inorganic Pharmacy- II
Course Code: BPH-121

Submitted to Submitted by
Aklima Akter Yeasin Hossain
Lecturer ID: 191-29-1479
Department of Pharmacy Batch: 21 (B)
Daffodil International University Daffodil International University

Date:09 -10-2019
What is FDA?
The Food and Drug Administration is a federal agency of the United States Department
of Health and Human Services, one of the United States federal executive department.

Theodore Roosevelt stublished it in 30 june 1906.Scott Gottlieb is running president of FDA .

History of FDA
Although it was not known by its present name until 1930, FDA's modern regulatory
functions began with the passage of the 1906 Pure Food and Drugs Act, a law a
quarter-century in the making that prohibited interstate commerce in adulterated and
misbranded food and drugs--had been the driving force behind this law and.

Where it Located?
The FDA has its headquarters in unincorporated White Oak, Maryland. The agency
also has 223 field offices and 13 laboratories located throughout the 50 states, the
United States Virgin Islands, and Puerto Rico.

What is the Role of FDA?

The Food and Drug Administration is responsible for protecting the public health by
ensuring the safety, efficacy, and security of human and veterinary drugs, biological
products, and medical devices; and by ensuring the safety of our nation's food supply,
cosmetics, and products that emit radiation

What does FDA Regulate?

The FDA regulates a wide range of products, including foods (except for aspects of
some meat, poultry and egg products, which are regulated by the U.S. Department of
Agriculture); human and veterinary drugs; vaccines and other biological products;
medical devices intended for human use; radiation-emitting electronic.
Regulated Product of FDA
Regulated Product Find Information given below:

Human Foods
Foods for human consumption, including dietary supplements, and color additives.

Human Drugs
Active pharmaceutical ingredients and both prescription and over-the-counter
medications.

Vaccines, Blood & Biologics

Biologic products such as human blood, blood donor screening tests, human tissue,
embryos, human plasma, and medical devices for use in blood banking operations

Medical Devices
Medical devices such as first aid kits, pacemakers, and surgical instruments.

Cosmetics
Cosmetic products such as shampoo, make-up, and face creams.

Animal and Veterinary

Animal food and feed as well as veterinary medicines

Tobacco Products
FDA-regulated tobacco products such as cigarettes, smokeless tobacco, e-cigarettes
and other electronic nicotine delivery systems, cigars, and all other tobacco products.

Radiation-Emitting Electronic Products

Radiation-emitting products such as x-ray machines, microwave ovens, CD-
ROMs, and laser pointers.
How FDA Regulates Drugs?
The Federal Drug Administration (FDA) has an immense responsibility to regulate
everything from bottled water to prescription drugs and beyond to vaccines and
cigarettes. In order to successfully fulfill their duties, the FDA spends months
evaluating and proposing regulations for new products or drugs. The process is not a
straight path from evaluation to regulation. Instead, it follows a cyclical path of
proposal, modification, and re-proposal until, finally, they reach a decision on the
product and create regulations.

How FDA Approve Drug?

There are many processes to approve a drug by FDA.
1.Regulating new drugs
2.The component of regulation
3.Label warnings
4.Implications of labeling

Why FDA Approval is Important?

FDA approval is important, because it validates the need for research on how drugs
work on children, not just adults. It also allows us the properly determine the
appropriate dosage for children, determine the best route of administration, and test for
any drug interactions.