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As part of its mission to supply economic analysis to FDA decision makers, the Office of Planning conducts economic analyses of all regulatory guidance, proposed rules, and final rules likely to have a significant economic impact. Each economic analysis includes an assessment of the costs and benefits of the regulation as well as the costs and benefits of the most promising alternatives to the regulation.
The following regulations and regulatory guidance documents have been analyzed to determine their economic impact. A summary of the economic analysis is found in each regulation under the heading “Analysis of Impacts” or "Analysis of Economic Impacts."
Medical Devices; Patient Examination and Surgeons’ Gloves; Test Procedures and Acceptance Criteria.
Final Rule (Federal Register, December 19, 2006)
Also available as PDF (112 KB)
Improves the barrier quality of medical gloves by reducing the current acceptable quality levels for leaks and visual defects observed during FDA testing of medical gloves. By reducing the acceptable quality levels for medical gloves, FDA will also harmonize its acceptable quality levels with consensus standards developed by the International Organization for Standardization (ISO) and ASTM International (ASTM).
Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products.
Final Rule. (Federal Register, January 24, 2006)
Also available as PDF (772 KB)
Revises current regulations to require that the labeling of new and recently approved products include highlights of prescribing information and a table of contents. The purpose of the final rule is to make it easier for health care practitioners to find and read information important for the safe and effective use of prescription drugs.
Electronic Products; Performance Standard for Diagnostic X-ray Systems and Their Major Components.
Final Rule (Federal Register, June 10, 2005)
Also available as PDF (321 KB)
Reduces exposure to ionizing radiation from diagnostic x-ray systems by requiring features on newly manufactured x-ray systems to minimize unnecessary or unnecessarily large doses of radiation that could result in adverse health effects to patients and health care personnel.
Use of Ozone-Depleting Substances; Removal of Essential-Use Designations.
Final Rule (Federal Register, April 4, 2005)
Also available as PDF (214 KB)
Sets a December 31, 2008 date for removing albuterol inhalers with chlorofluorocarbons from the market. Chlorofluorocarbons destroy ozone and their use is discouraged by international environmental treaty.
Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments; Inspection and Enforcement.
Final Rule (Federal Register, November 24, 2004)
Also available as PDF (401 KB)
Requires human cell, tissue, and cellular and tissue-based product establishments to follow current good tissue practice, which governs the methods used in, and the facilities and controls used for, the manufacture of human cell, tissue, and cellular and tissue-based products; recordkeeping; and the establishment of a quality program.
Bar Code Label Requirements for Human Drug and Biological Products.
Final Rule (Federal Register, February 26, 2004)
Also available as PDF (320 KB)
Requires certain human drug and biological product labels to have barcodes. The rule will help reduce the number of medication errors in hospitals and other health care settings by allowing health care professionals to use bar code scanning equipment to verify that the right drug (in the right dose and right route of administration) is being given to the right patient at the right time.
Applications for FDA Approval to Market a New Drug: Patent Submission and Listing Requirements and Application of 30-Month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug Is Invalid or Will Not Be Infringed.
Final Rule (Federal Register, June 18, 2003.)
Also available as PDF (1.18 MB)
Clarifies the types of patents that must and must not be submitted and revises the declaration that new drug applications must provide regarding their patents to help ensure that applicants submit only appropriate patents. The final rule revises the regulations regarding the effective date of approval for certain abbreviated new drug applications and certain other new drug applications, known as 505(b)(2) applications. The final rule also states that there is only one opportunity for a 30-month stay in the approval date of each abbreviated new drug application and 505(b)(2) application.
Over-the-Counter Human Drugs: Labeling Requirements.
Final Rule (Federal Register, March 17, 1999)
Also available as PDF (1.2 MB)
Establishes a standardized format and standardized content requirements for the labeling of over-the-counter (OTC) drug products. This final rule assists consumers in reading and understanding over-the-counter drug product labeling so that they may use these products safely and effectively.
Pharmaceutical Industry Cost Savings Through Use of the Scale-up and Post-Approval Change Guidance for Immediate Release Solid Oral Dosage Forms (SUPAC-IR).
January 7, 1998
Only available as PDF (186K)
A report on the impact and cost savings to industry of the SUPAC-IR guidance.
Medical Devices; Classification/Reclassification; Restricted Devices; Analyte Specific Reagents.
Final Rule (Federal Register, Nov. 21, 1997)
Also available as PDF
Reclassifies analyte specific reagents (ASRs) according to their risk to public health, and designates all ASRs as restricted devices under the Federal Food, Drug, and Cosmetic Act, establishing restrictions on their sale, distribution and use.
Quality Mammography Standards.
Final Rule (Federal Register, Oct. 28, 1997)
Also available as PDF (83 KB)
Amends FDA's regulations governing mammography, setting requirements for accreditation bodies, procedures for facility certification, and quality standards for mammography personnel, equipment, and practices, including quality assurance |
