Effectiveness of Risk Evaluation and Mitigation Strategies (REMS) for Lenalidomide and Thalidomide: Patient Comprehension and Knowledge Retention.

Introduction: The effectiveness of patient education activities conducted within the lenalidomide and thalidomide risk evaluation and mitigation strategies (REMS) programs was evaluated by measuring understanding of serious risk and safe-use messages.

Methods: Results from mandatory knowledge, attitude, and behavior surveys and voluntary patient surveys completed between June 2012 and June 2013 were analyzed, and responses to questions relating to compliance with birth control measures and understanding of safe-use messages are presented by patient risk category.

Results: In total, 73,645 patients were enrolled into the REMS programs for lenalidomide and thalidomide and completed mandatory surveys prior to medication dispense.

Teratogenic Drugs and Risk Management: An Implementation Assessment.

About half of all pregnant women are prescribed medication during their pregnancy, including drugs with teratogenic potential. There is a need to manage teratogenic risk and prevent fetal harm. In the US, risk management strategies may range from product labeling to the US Food and Drug Administration requiring a risk evaluation and mitigation strategy, including elements to assure safe use.

Managing the teratogenic risk of thalidomide and lenalidomide: an industry perspective.

Celgene has developed and operated pregnancy prevention programs since 1998 with the first approval of thalidomide in the US. With the development and marketing of lenalidomide, an analog of thalidomide, the company further advanced its risk management activities, which now cover several territories across the globe. To date, the program is a success in as much as it has minimized the risk of fetal exposure and subsequent development of fetal malformations.

Considerations for licensure of influenza vaccines with pandemic and prepandemic indications.

With over 409 human cases of avian influenza and over 256 deaths worldwide resulting from infection with avian influenza (H5N1), an influenza pandemic is still a real threat, especially with H5N1 continuing to evolve into antigenically distinct clades. The Food and Drug Administration (FDA) along with other national regulatory authorities (NRAs) recognize the important role that safe and effective vaccines will play in protecting the public health from the threat of an influenza pandemic. The challenges to the FDA and other NRAs are significant as regulatory agencies pursue the development of new scientific and regulatory criteria to evaluate vaccines against pandemic influenza strains for licensure.

Quantitative determination of cesium binding to ferric hexacyanoferrate: Prussian blue.

Ferric hexacyanoferrate (Fe4III[FeII(CN)6]3), also known as insoluble Prussian blue (PB) is the active pharmaceutical ingredient (API) of the drug product, Radiogardase. Radiogardase is the first FDA approved medical countermeasure for the treatment of internal contamination with radioactive cesium (Cs) or thallium in the event of a major radiological incident such as a "dirty bomb". A number of pre-clinical and clinical studies have evaluated the use of PB as an investigational decorporation agent to enhance the excretion of metal cations.

The radioactive drug research committee: Background and retrospective study of reported research data (1975-2004).

In the United States, human research involving radioactive drugs must be conducted under a Food and Drug Administration (FDA) investigational new drug (IND) application, unless specifically exempt from IND requirements, or under the direct oversight of a Radioactive Drug Research Committee (RDRC) as long as certain conditions are met. Research overseen by RDRCs is considered basic science research when its purpose is to advance scientific knowledge and not to determine a radioactive drug's safety and effectiveness as a therapeutic, diagnostic, or preventive medical product in humans. We retrospectively reviewed and analyzed available study data from annual reports submitted to the FDA dating back to 1976.

Screening mammography: clinical image quality and the risk of interval breast cancer.

Objective: We evaluated the association between clinical image quality and breast cancer occurrence within 24 months of a negative mammogram.

Materials And Methods: We identified women with breast cancer who were younger than 40 years old and older and screened from January 1, 1988, through December 31, 1993. We retrospectively assigned Breast Imaging Reporting and Data System (BI-RADS) assessments to their screening mammogram.

Study design in the evaluation of breast cancer imaging technologies.

Rationale And Objectives: Bringing a new imaging technology to market is a complex process. Beyond conceptualization and proof of concept, obtaining U.S.

Mammography in the 1990s: the United States and Canada.

Purpose: To evaluate trends in mammography quality before and after the implementation of the Mammography Quality Standards Act (MQSA) of 1992 and to compare technical data collected in the United States with corresponding data obtained from the first survey of mammography facilities conducted in 1994-1995 in Canada.

Materials And Methods: Data from MQSA inspections conducted in 1995-1997 were analyzed and compared with survey data on U.S.

The impact of the Mammography Quality Standards Act on the availability of mammography facilities.

Background: The Mammography Quality Standards Act (MQSA) became effective October 1, 1994, and requires all mammography facilities to meet quality standards as promulgated by the Food and Drug Administration (FDA). The FDA undertook an assessment of the MQSA federal certification requirements on the availability of mammography facilities.

Methods: A survey of states on mammography facility closures between October 1, 1993, and October 1, 1994, was conducted.

The impact of mammography quality improvement legislation in Michigan: implications for the National Mammography Quality Standards Act.

Objectives: This study examined the impact of state legislation on mammography quality and access in Michigan.

Methods: The impact of state legislation was analyzed with respect to utilization, numbers of machines and facilities, and image quality.

Results: The legislation had a positive effect on image quality improvement, had no impact on utilization by women aged 50 years and above, and resulted in few facility closures.

The Mammography Quality Standards Act and interventional mammography procedures.

The Food and Drug Administration (FDA) is in the early stages of developing regulations regarding mammographic interventional procedures. When implemented, the regulations have a significant impact on the way these procedures are performed. As part of the development process, the FDA is working with the American College of Surgeons (ACS), the American College of Radiology (ACR), and other interested professional and consumer groups.

The influence of risk factors on breast carcinoma screening of Medicare-insured older women. National Cancer Institute Breast Cancer Screening Consortium.

Background: It is not certain whether older women with additional breast carcinoma risk factors are adequately screened or whether they are more likely to undergo screening than other older women. This study was conducted to determine whether selected risk factors influence the breast carcinoma screening rates of Medicare-insured older women (i.e.

Screening mammography in community practice: positive predictive value of abnormal findings and yield of follow-up diagnostic procedures.

Objective: The purpose of this study was to gather from 50 community mammography practices that were included in the National Survey of Mammography Facilities data concerning abnormal findings on screening mammograms to determine the frequency of various recommendations made for patients who had abnormal findings and to compare these recommendations with the frequency with which the procedures were actually performed. We also determined the positive predictive value of screening mammograms (the number of cancers detected per 100 abnormal findings) and the yield (the number of cancers detected per 100 procedures done) of various diagnostic procedures done because of abnormal findings.

Materials And Methods: We identified 1717 screening mammograms done in the last half of 1991 that had abnormal findings.

The Mammography Quality Standards Act of 1992. History and philosophy.

The Mammography Quality Standards Act (MQSA) of 1992 established a precedent in the practice of mammography by creating federal quality standards for all parts of the mammography system. Heralded by some as crucial so all US women can reap the full benefits of early detection of breast cancer, MQSA implementation was delegated to the Food and Drug Administration (FDA) on June 2, 1993. In this article the major historical forces that surrounded MQSA's enactment as well as the FDA's philosophy on regulation development, inspections, and compliance under MQSA is summarized.

The association between alcohol and breast cancer: popular press coverage of research.

Objectives: This study was undertaken to examine popular press reports of the association between alcohol and breast cancer.

Methods: Articles from scientific journals and stories from newspapers and magazines published from January 1, 1985, to July 1, 1992, were retrieved from six on-line databases. Lay press stories were analyzed to determine which medical articles were publicized and what information was reported.

Predictors of and satisfaction with bilateral prophylactic mastectomy.

Background: Women with a first-degree relative with breast cancer are at increased risk of developing this disease. The optimal medical management of these women is unclear, with options including close breast cancer screening, bilateral prophylactic mastectomy, or participation in chemoprevention trials. Among women who undergo prophylactic bilateral mastectomy, very little is known about satisfaction with this surgery.

The practice of prophylactic mastectomy: a survey of Maryland surgeons.

Objectives: Bilateral prophylactic mastectomy is a drastic breast cancer preventive option for which indications are not standardized and efficacy has not been proven. To estimate the magnitude of this controversial practice, surgeons were surveyed on their recommendations about and performance of prophylactic mastectomy.

Methods: A cross-sectional survey was sent to general surgeons (n = 522), plastic surgeons (n = 80), and gynecologists (n = 801) licensed to practice in Maryland in 1992.

Quality assurance audits of community screening mammography practices: availability of active follow-up for data collection and outcome assessment.

Objective: Routine and periodic mammography audit studies, the systematic evaluation of clinical follow-up procedures and outcomes subsequent to screening mammography reports of abnormal findings, have been advocated as an important component of quality assurance in screening mammography. This study assessed the degree to which mammography facilities in community practice maintain reporting and record-keeping systems and ascertain sufficient clinical follow-up data to facilitate the practice of mammography audit studies.

Materials And Methods: As part of a national survey of 1057 mammography facilities, data were collected from a stratified subsample of 50 facilities on facility information systems, and facility records were systematically abstracted to determine the degree of completeness of clinical follow-up data to screening mammography examinations with abnormal findings.

Current practice of screening mammography in the United States: data from the National Survey of Mammography Facilities.

Purpose: To describe the extent to which screening mammography (SCM) has been organized according to the public health concept of low-cost, high-quality, and population-based screening, selected indicators of U.S. mammography facilities were evaluated.