TITLE: Tobacco Retailer Study: Arkansas Pilot Methods Report
ABSTRACT: The U.S. Food and Drug Administration (FDA) has developed a national campaign targeted at tobacco retailers. The purpose of the campaign is to raise awareness of the new requirements that prohibit retailers from selling cigarettes and smokeless tobacco products to persons younger than age 18 and require that retailers verify, by means of photographic identification, the age of purchasers who are younger than age 27. The purpose of the evaluation was to determine if the media campaign was effective. Results of a survey of tobacco retailers suggest that the media campaign is effective in increasing the awareness of the new requirements among retailers.
AGENCY SPONSOR: Center for Food Safety and Applied Nutrition
FEDERAL CONTACT: Alan Heaton
PHONE NUMBER: 202-205-5394
PIC ID: 7079
PERFORMER ORGANIZATION: Market Facts, Inc., McLean VA
DRUG APPLICATION REVIEW
TITLE: Report of the Prescription Drug User Fee Act (PDUFA) of 1992-Fiscal Year 1998 Report to Congress
ABSTRACT: As reported in the PDUFA FY 1998 Performance Report, the Food and Drug Administration exceeded all performance goals specified under the Prescription Drug User Fee Act of 1992 (PDUFA). The Agency made its review decisions for drug and biological product submissions on time in almost every case, reviewing 100 percent of the new product applications and 99 percent of the supplements within target time reviews. By historic standards, approval rates remain high and review times and total approval times remain short. The Food and Drug Administration Modernization Act of 1997 (FDAMA) continues the progression toward quicker reviews begun under PDUFA, and extends into the investigative phase of drug development with a series of new goals that take effect in FY 99. The objective of the FDAMA goals is to speed up the entire drug development process, from research to approval, without compromising safety or sacrificing quality of the application review process.
AGENCY SPONSOR: Office of Planning and Evaluation
FEDERAL CONTACT: Dennis Hill
PHONE NUMBER: 301-827-5255
PIC ID: 6079.3
PERFORMER ORGANIZATION: Office of Planning & Evaluation, Food and Drug Administration, Rockville MD
TITLE: Pharmaceutical Industry Cost Savings Through Use of the Scale-up and Post-Approval Change Guidance for Immediate Release Solid Oral Dosage Forms (SUPAC-IR)
ABSTRACT: The purpose of this study was to assess the impact on and cost savings to the pharmaceutical industry of the SUPAC-IR guidance. The purpose of the guidance was to implement an improved process for post-approval changes to approved drug applications involving chemistry, manufacturing and control changes. The results of the study, based on interviews with representatives of six pharmaceutical companies indicates that SUPAC-IR guidance: 1) enhances the industry's ability to plan and implement change and mange resources efficiently; 2) facilitates changes that can be implemented more confidently, quickly and efficiently; 3) generates substantial savings; and 4) enhances the application of scientific principles to improving the supplement process.
AGENCY SPONSOR: Office of Planning and Evaluation, FDA
FEDERAL CONTACT: Nancy Gieser
PHONE NUMBER: 301-827-5335
PIC ID: 7059
PERFORMER ORGANIZATION: Eastern Research Group, Inc., Herndon, VA
TITLE: Readership Survey Analysis for the FDA Public Health Advisory: Interference between Digital TV Transmitters and Medical Telemetry Systems
ABSTRACT: The FDA Center for Devices and Radiological Health uses Safety and Public Health Advisories to transmit information pertaining to radiological health risks of medical devices to health care practitioners. An evaluation was conducted to determine the impact of these advisories on the behavior and knowledge of the recipients. Most respondents felt that the problem addressed in the advisory was clearly identified, easily understood, timely and useful, and that actions for reducing risks were clearly enumerated. Approximately 37 percent of the sample group reported that they had taken actions to eliminate or reduce the risk as a result of the advisory. The most commonly reported reason for not taking action was that the subject matter of the advisory was not applicable.
AGENCY SPONSOR: Center for Devices and Radiological Health
FEDERAL CONTACT: Gary Blanken
PHONE NUMBER: 301-594-1284
PIC ID: 6733.1
PERFORMER ORGANIZATION: Food and Drug Administration, Rockville MD