USFDA

CONTENTS

DEFINITION

HISTORY.

ORGANIZATION AND THEIR REGULATORY PROGRAM.

FORMS AND SUBMISSION REQUIREMENTS.

DEFINITION: The U.S. Food and drug administration is an agency of the

United States Department of Health and Human services and is responsible for the safety regulation of most type of foods, dietary supplements, drug, vaccines, biological medical products, blood products, medical devices, radiation – emitting devices, veterinary products, and cosmetics. The agency of the U.S. Department of Health and Human Services. Established in 1927.

HISTORY ORIGINS OF FEDERAL FOOD AND DRUG REGULATION:

Until the 20th century, there were few federal laws regulating the contents and sale of domestically produced food and pharmaceuticals, with one exception being the short-lived Vaccine Act of 1813.

A patch work of state laws provided degrees of protection against unethical sales, such as misrepresenting the ingredients of food products or therapeutic substances.

The history of the FDA can be traced to the latter part of the 19th century and the U.S Department of Agriculture’s Division of Chemistry Under Harvey Washington Wiley, appointed chief chemist in 1883, the division began conducting research into the adulteration and misbranding of drug on the American market.

The 1906 food and drug act and creation of the FDA

In June 1906, President Theodore Roosevelt signed in to law the food and drug act, also known as “Wiley act” after its chief advocate.

The act prohibited, under penalty of seizure of goods, and “adulterated”foods, reduced “quality or strength”, “damage or inferiority” formulation with additives “injurious to health” or the use of “filthy, decomposed, or putrid” substances.

In 1927, the Bureau of chemistry’s regulatory powers were reorganized under a new USDA body, the food, drug, and insecticide organization. This name was shortened to FDA, three years later.

THE 1938 FOOD, DRUG, AND COSMETIC ACT In 1930s, Muckraking journalists, began consumer

protection organizations, and federal regulators for stronger regulatory authority by publicizing a list of injurious products. Including radioactive beverages, cosmetics which caused blindness, and worthless.

Elixir sulfanilamide tragedy, FDA seize the product was due to misbranding problem, defined as a medication dissolved in ethanol, not the diethylene glycol.

The law also authorized factory inspections and enforcement powers, set new regulatory standards for foods, and brought cosmetics and therapeutic devices under federal regulatory authority.

ORGANIZATION

The agency is the organized in to the following major subdivisions each focused on a major area of regulatory responsibility

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 Office of Regulatory Affairs (ORA) The Office of Criminal Investigations( OCI)

The Office of the Commissioner(OC)

In the United States, the Commissioner of Food and Drugs is the head of the Food and Drug Administration. The Commissioner report to the secretary of the Department of Health and Human Services and is a presidential appointment with the advice and consent of the Senate.

The Center for Drug Evaluation and Research (CDER)

The center for Drug Evaluation and Research is a division of the FDA that monitors most drug as defined in the FD&C Act.

The center reviews applications for new and generic pharmaceuticals, manages US cGMP regulations for pharmaceutical manufacturing, determines which medications require a prescription, monitors advertising of approved medications, and collects and analyzes safety data about pharmaceuticals that are already on the market.

CDER is the largest of FDA’s five centers. It has responsibility for both prescription and over-the-counter drugs

Advertising and Promoting The FDA reviews and regulates prescription drug

advertising and promotion. The federal Trade Commission regulates. The drug advertising regulation contains two key requirements. Under most circumstances, a company many only advertise a drug for the specific indication or medical use for which it was approved. “Off-label use”, using a drug for other than its approved purpose is common in medical practice. Also, an advertisement must contains “fair balance” between the benefits and risks of a drug .

Development & Approval Process New drugs

New drug receive extensive scrutiny before FDA approval in a process called a New Drug Application or NDA. New drug are available only by prescription by default. A change to Over the counter (OTC) status is a separate process and the drug must be approved through an NDA first.

CDER reviews New Drug Applications to ensure that the drug are safe and effective. It is one of the centers at the united states Food and Drug Administration. Its primary objective is to ensure that all prescription and over-the –counter ( OTC) medications are safe and effective when used as directed. The main consumer watchdog in this system is the U.S Food and Drug Administration’s Center for Drug Evaluation and Research (CDER).

The Center for Biologics Evaluation and Research (CBER)

The center for Biologics Evaluation and Research ( CBER) is one of six main center for the Food and Drug Administration , which is a part of the U.S. Department of Health and Human Services.

The original authority for governmental regulation of biological product was eastablished by the 1902 Biologics Control Act, with additional authority established by the 1944 Public Health Service Act.

CBER is responsible for assuring the safety, purity, potency and effectiveness of bilogical and regulated products, including:

Blood and Blood Products Vaccines Cellular & Gene Therapy Products Xenotransplantation. Human cell, tissues, and cellular and tissue-based

products. Allergenic extracts.

The Center for Food Safety and Applied Nutrition (CFSAN)

The center for food safety and Applied Nutrition is the branch of the FDA which is responsible for ensuring the safety and accurate labeling of nearly all food product in the United States.

Labeling & Nutrition

These FDA Food the labeling requirements for foods under the Federal Food Drug and Cosmetics Act and its amendments. Food labeling is required for most prepared foods, such as breads, cereals, canned and frozen foods, snacks, desserts, drinks, etc.

Cosmetics Cosmetics are regulating by the center for food

safety and Applied Nutrition, the same branch of the FDA that regulates food. Cosmetics products are not generally subject to pre- market approval by the FDA unless they make “structure or function claims” which make them into drugs.

The Center for Devices and Radiological Health (CDRH)

The Center for Devices and Radiological Health (CDRH) is the branch of the United States Food Drug Administration responsible for the premarket approval of all medical devices. The CDRH also oversees the radiation safety performance and safety of devices which emit certain type of electromagnetic radiation, such as cellular phones and microwaves ovens.

The Center for Veterinary medicine (CVM)

The Center for Veterinary medicine (CVM) is a branch of the FDA, which regulates the manufacture, and distribution of food, food additives, and drugs that will be given to animals. These include animals, from which human food are derived, as well as food additives and drug for pets or companion animals. CVM is responsible for regulating drugs, devices, and food additives given to or used on, over one hundred million companion animals, plus millions of poultry, cattle, swine, and minor animals species.

The Office of Regulatory Affairs (ORA)

ORC and OCI are primarily filed offices, with their workforce spread across the country . ORC is considered the “eyes and ears” of the agency, conducting the vast majority of the field work the agency. Consumer safety officers, more commonly called investigators, are the individuals who inspects production and warehousing facilities, investigate complaints, illnesses, or outbreaks, and review documentation in the case of medical devices, drugs, biological products, and other items where it may be difficult to conduct a physical examination or take a physical sample of the products.

The Office of Criminal Investigations (OCI)

OCI was established in 2002 to help relieve ORC of the burden of pursuing and proving criminal cases. Unlike ORA investigators, OCI Special Agents are armed, and are not focused on the technical aspects of whether a regulated product meets the standards under the law.

FORMS AND SUBMISSION REQUIREMENTS

Investigational New drug forms (IND) FDA 1571- IND Applications FDA 1572- Statement of investigator New Drug Application Forms (NDA) Form FDA-356h-Application to market a new Drug,

Biologic, or An Antibiotic Drug for Human Use Form FDA-3397-User Fee Cover Sheet Form FDA-3331-New Drug Application Field Report Abbreviated New Drug Application Forms (ANDA) For

Generic Drug Product Form FDA-356h-Application to Market a New Drug,

Biologic or An Antibiotic Drug For Human Use.