RAPS FDA History Chapter 1

Under which branch of government does FDA fall?

$$$ worth of goods that FDA regulates today

In the 19th centruy, how were food and drugs regulated

What was the first federal law dealing with consumer protection and theraeutic substances?

Who is credited as the father of US food and drug law?

When able-bodied volunteers were asked to consume varying amounts of quationable food additives to determine their impact on health, it was called...

Which book was the precipitating force behind meat inspection law and comprehensive food and drug law?

When and by whom was the Food and Drug Act first signed?

The Food and Drug Act of 1906 was also known as?

How many Centers are there within FDA?

Which center is responsible for efficient and effective implementation of FDA's mission? 

Which office of FDA represents FDA in court proceedings, and rovices legal advice and policy guidance for FDA programs?

Which office of FDA provides strategic leadership, coordination and expertise to support scientific excellence, innocation and capacity?

Which offices report to the Office of Chief Scientist?

Which office is the focal point for all international FDA matters, particpating in such programs as the Trilateral Corporation, WHO, Pan American Health Organization, Codex Alimentarious, and The International Conference on Harmonization?

Which office serves as the agency focal point for special programs and initiatives that ae cross-cutting, scientific and/or regulatory in nature?

Which office coordinates internal and external review of pediatric science, safety, ethical and international issues as mandated by law and agency activities

Which office oversees the implementation of te orphan products provisions of the FD&C act?

Which office has executive leadership tothe office of good clinical practice?

Which office oversees the functions of the Office of Combination Products as provided in the FD&C Act?

Which office works with all FDA centers to provide consistent operations and seek continuous improvements in the agency advisory committe program?

Which office serves as the liaison with the Office of the Secretry, the DHHS Committee Management Office, all of FDA's center advisory support staff and other organizations/offices within FDA?

Which office is responsible for ensuring that all FDA committee managememt actiities are consistent with the provisions of Federal Advisory Committee Act, departmental policies, and related regulations and statutes?

Which offices report to the Office of Special Medical Programs?

Which center evaluates all new prescription and over-the-counter drugs before they are sold to ensure that they are safe and effective?

Which center regulates biological products for disease prevention and treatment, including vaccines, protein-based products such as monoclonal antibodies and cytokines and bllod, blood products such as plasma, blood-derived proteins, tests used to screen blood donors and devices used to make blood products?

Which center is tasked with ensuring that all new medical devices are safe and effective befoe the are marketed, and also regulates devices and radiation emitting products such as microwaves, TVs, cell phones, and lasers to ensure they meet radiation safety standards?

Which center helps ensure that animal-food products are safe, regulates the manufacture and distribution of food additives and drugs that will be given to animals, and evaluates the safety and effectiveness of drugs use to treat companion animals?

Which center is responsible for the safety of almost all food consumed in the US wit the exception of meat, poultry, and some egg products?

For those consumer foods not regulated by CFSAN, who is responsible?

Which system, which places preventative controls as the most contamination-prone points in the production process, did CFSAN (Center for Food Safety and Applied Nutrition) pioneer?

Which center conducts research and provides advice and training necessary for science-based decision making and developing sound regulatory policy?

Which center is responsible for overseeing the implementation of the Family Smoking Prevention and Tobacco Control Act?

When did the Family Smoking Prevention and Tobacco Control Act become law?

Which Office advises and assists the FDA commissioner and other key officials on regulations and compliance matters, evaluates and coordinates all proposed FDA legal actions to asertain compliance with regulatory policy and enforcment objectives?

Which office is the lead for all FDA field activities and executes direct line authority over all field operations?

Which document provides guidance to FDA field stff on the inspectional process used to assess a manufacturer's compliance with the Quality System Regulations?

What does FTC stand for?

Which Act prohibits unfair or deceptive acts or practices in or affecting commerce, the dissemination of any false advertisment for the purpose of inducting the purcase of food, drugs, devices, services, or cosmetics?

FTC has primary jurisdiction over the advertising of products other than ____________ (which is regulated by FDA per a 1971 memorandum of understanding)?

What is the FTC's secure, online complaint database?

What is the name of the federal agency within the Department of Health and Human Services responsible for medicare, medicaid and other programs?

Which Center has jurisdiction over the Health Insurance Portability and Accountability Act, enacted in 1996 to create a national standard for protecting the privacy of patients personal health information (PHI)?

Healthcare entities may not ue or disclose ______ without an individuals written authorization with only some exceptions as permitted and required by law.

HIPAA stands for...

Which commission is responsble for ensuring the safety of consumer goods such as household appliances (excluding those that emit radiation), paint, child-resistant packagesand baby toys?

Name three products that are expressly exempt from the from regulation under the Consumer Product Safety Act (CPSA) because they are subject to another goverment jurisdiction?

Give an example of how FDA & CPSC work cooperativly for consumer protection.

Which commission's primary mission is to protect the investing public and maintain the integrity of the securities market?

True or False.

FDA employees may report suspicious public statements to the attention of the SEC?
True False

Which act created an administration at the federal level witing the department of labor who's mission is to prevent work-related injuries, illnesses, and deaths by issuing and enforcing rules (called standards) for workplace safety and health?

Which act provides for federal regulationof beer, wine, and distilled spirits, and establishes requirements for packaging used to hold alcohol over and above those imposed by FDA for foods under the FD&C act. 

Which bureau administers the FAAA?

Which department has oversight of dairy, poultry, fruit and meat products except for shell eggs, for which FDA and USDA share jurisdiction?

Which components of egg manufacturing are regulated by USDA?

Define the term "poultry" (according to the Poultry Product Inspection Act)

FDA regulates many food groups, but ______ is one of the few FDA-regulated food groups further regulated under a system of risk prevention controls known as ___________.

The mission of _______ is to protect human health and the environment, which includes jurisdiction over the public water supply.

The passage of which Act (and in which year) implicitly repealed FDA's authority under the FD&C act over drinking water?

Although anitmicrobial surface solutions applied to counter tops, table tops, food processing equipment, cutlery, dishware or cookware, to sanitize such objects after they have been washed are regulated as "pesticide chemicals" by EPA, this exception is instead regulated by  FDA as they are considerd food additives.

True or False.  FDA, USDA, and EPA share responsibility for regulating pesticides.
True False

Illegal drugs with no approved medical use, such as heroin and cocaine, are under the jurisdiction of which federal agency?