Third Set: 2000s

Question 1

When is Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products approved

Answer 1

2006

Question 2

Drug Safety Board

Answer 2

created in 2005.

Consists of :
FDA staff
Representatives from the National Institutes of Health and the Veterans Administration.

Advises on drug safety issues and work with the agency in communicating safety information to health professionals and patients.

Question 3

What are the three guidelines published to fulfill FDA’s commitment to the risk management performance goals?

Answer 3

Premarketing Risk Assessment
Development and Use of Risk Minimization Action Plans
Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment

Question 4

Cox-2 Selective agents

Answer 4

2004; Based on results from controlled clinical studies indicating that Cox-2 selective agents may be connected to an elevated risk of heart attack and stroke, FDA issues a public health advisory urging health professionals to limit the use of these drugs.

Question 5

Anabolic Steroid Control Act

Answer 5

2004; A ban on over-the-counter steroid precursors, increased penalties for making, selling, or possessing illegal steroids precursors, and funds for preventive education to children

Question 6

Project Bioshield Act

Answer 6

2004; authorizes FDA to expedite its review procedures to enable rapid distribution of treatments as countermeasures to chemical, biological, and nuclear agents that may be used in a terrorist attack against the U. S., among other provisions.

Question 7

What is “Innovation or Stagnation? – Challenge and Opportunity on the Critical Path to New Medical Products.”

Answer 7

2004; It examines the critical path needed to bring therapeutic products to fruition, and how FDA can collaborate to make medical breakthroughs available to those in need as quickly as possible.

Question 8

Medicare Prescription Drug Improvement and Modernization Act 2

Answer 8

2003; requires that a study be made of how current and emerging technologies can be utilized to make essential information about prescription drugs available to the blind and visually impaired.

Question 9

Pediatric Research Equity Act

Answer 9

2003- FDA is given clear authority under the Pediatric Research Equity Act to require that sponsors conduct clinical research into pediatric applications for new drugs and biological products.

Question 10

Prescription Drug User Fee Act of 1992 (PDUFA III)

Answer 10

in 2002, receives its third five-year extension. The reauthorization requires pilots for risk management, good review manufacturing practices and a continuous marketing application. PDUFA III continues goals for meetings with industry and to shorten review time.

Question 11

When does the FDA publish a guidance for industry that provides advice on establishing registries that monitor the outcomes of pregnancies in women exposed to a specific drug?

Answer 11

2002

Question 12

Current good manufacturing practice (cGMP) initiative.

Answer 12

2002; An effort to enhance and update the regulation of manufacturing processes and end- product quality of animal and human drugs and biological medicines is announced.

Goals: focus on the greatest risks to public health in manufacturing procedures, to ensure that process and product quality standards do not impede innovation, and to apply a consistent approach to these issues across FDA.

Question 13

Public Health Security and Bioterrorism Preparedness and Response Act

Answer 13

2002; is designed to improve the country’s ability to prevent and respond to public health emergencies. Provisions include a requirement that FDA issue regulations to enhance controls over imported and domestically produced commodities it regulates.

(in response to 9/11)

Question 14

Bar codes

Answer 14

2004; FDA regulation calls for over-the-counter medicines commonly used in hospitals and all prescription medicines to have a bar code. The bar code rule aims to protect patients from preventable medication errors.

Question 15

Best Pharmaceuticals for Children Act

Answer 15

2002; improves safety and efficacy of medicines for children. It continues the exclusivity provisions for pediatric drugs as mandated under the Food and Drug Administration Modernization Act of 1997, in which market exclusivity of a drug is extended by six months, and in exchange the manufacturer carries out studies of the effects of drugs when taken by children. The provisions both clarify aspects of the exclusivity period and amend procedures for generic drug approval in cases when pediatric guidelines are added to the labeling.

Question 16

Data Quality Act

Answer 16

2000; Federal agencies are required to issue guidelines to maximize the quality, objectivity, utility, and integrity of the information they generate, and to provide a mechanism whereby those affected can secure correction of information that does not meet these guidelines.

Question 17

Tabasco as a drug ruling in 2000

Answer 17

The U. S. Supreme Court, upholding an earlier decision in Food and Drug Administration
v. Brown & Williamson Tobacco Corp. et al., rules 5-4 that FDA does not have authority to regulate tobacco as a drug. Within weeks of this ruling, FDA revokes its final rule, issued in 1996, that restricted the sale and distribution of cigarettes and smokeless tobacco products to children and adolescents, and that determined that cigarettes and smokeless tobacco products are combination products consisting of a drug (nicotine) and device components intended to deliver nicotine to the body.

Question 17

Tabasco as a drug ruling in 2000

Answer 17

The U. S. Supreme Court, upholding an earlier decision in Food and Drug Administration
v. Brown & Williamson Tobacco Corp. et al., rules 5-4 that FDA does not have authority to regulate tobacco as a drug. Within weeks of this ruling, FDA revokes its final rule, issued in 1996, that restricted the sale and distribution of cigarettes and smokeless tobacco products to children and adolescents, and that determined that cigarettes and smokeless tobacco products are combination products consisting of a drug (nicotine) and device components intended to deliver nicotine to the body.