Search PubMed⌕ Search

SEARCH · Search PubMed

Results for “Government Regulation”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 91 records · Page 5Linked to original sources
PubMed2005

Regulations governing veterinary medicinal products containing genetically modified organisms in the European community.

This paper describes particular aspects of the marketing of veterinary medicinal products (VMPs) that contain or consist of genetically modified micro-organisms (GMMs) or genetically modified organisms (GMOs). The regulatory requirements and the procedures applied in the European Union for each phase (pre-marketing, authorisation process, and post-authorisation labelling and monitoring) are explained. In most cases VMPs are subject to both pharmaceutical and GMO regulations. In the early stages of the process, before applications for marketing authorisation are submitted, the assessment of clinical trials and experiments in contained areas is principally the responsibility of national authorities. However, the marketing of all VMPs containing or consisting of GMOs must be authorised at European level, although the national authorities are informed and involved in the assessment process.

Animals↗
PubMed1998

Managed care at the crossroads: can managed care organizations survive government regulation?

Attorneys Brown and Hartung provide a comprehensive overview of the development and structural components of managed health care plans. The article discusses the state regulatory controls affecting managed care including Patient Protection Acts, mandated benefit provisions, any willing provider laws, and consumer access provisions. The article considers liability problems facing managed care organizations, in particular liabilities which arise from utilization and medical review discussions as well as gag clauses and financial incentive arrangements. The authors also review relevant federal regulatory initiatives.

Community Networks↗
PubMed1967

Government regulations and the use of drugs.

I have tried to trace the new drug development pattern from 1766, when Withering obtained his medical degree, to the present. The role of governmental authority as defined by the 1962 Kefauver-Harris amendments to the 1906 law and the subsequently issued regulations has been summarized. Four phases of testing in man have been detailed. Something of the scientific or research capability of the pharmaceutical industry has been presented. It is concluded that in the period of over two hundred years of medical education in the United States, the university hospital has become more and more the focus of medical research, teaching and practice in the community. The safety and effectiveness in the use of drugs in the future will depend upon the liaison and rapport of the industry physicians, government officials and the university hospital teacher-clinical investigators (phase 1 and 2) in designing the most critical studies of the safety and effectiveness of new drugs. Whether the medical profession as we know it will participate more in the future than has been possible since 1962 in mass clinical trial (phase 3) before new drug approval by governmental authority remains to be seen. The final approbation or disapproval of a drug after NDA approval (phase 4) will continue to be in the hands of the participating physician as long as he can establish scientifically that the drug is the best possible agent for him to use in healing the sick and comforting the dying.

History, 18th Century↗
PubMed1993

Anaesthesia equipment safety in Canada: the role of government regulation.

Medical device problems as detected by the Health Protection Branch (HPB) of Health and Welfare Canada were studied in order to examine the frequency and safety priority of problems in the subgroup of anaesthesia devices. Data pertaining to the time period from April 1, 1987 to November 30, 1992 were gathered from the Medical Devices Notification Database and the DAFFY Reporting System. The Medical Devices Notification Database contains all notifications for newly marketed medical devices in Canada and the DAFFY Reporting System keeps record of all submitted problem reports and manufacturer recalls along with their designated safety priority status. When an important safety hazard is associated with a medical device as determined from information submitted to HPB, an Alert-Medical Devices may be issued to inform hospitals and health care professionals of the problem. During the studied time period, the percentages of problem reports and recalls as well as Alerts were compared with the percentage of newly marketed anaesthesia devices. It was found that although only 2.3% of the newly marketed medical devices were classified as anaesthesia devices, 8.6% of all problem reports/recalls and 37.5% of all Alerts originated from the field of anaesthesia devices. Comparison of the percentages of problem reports/recalls (8.6%) and Alerts (37.5%) with the percentage of marketed devices for anaesthesia (2.3%) showed differences (P < 0.05). As well, the percentage of class I priority (the highest safety priority) problem reports/recalls for anaesthesia devices was 10.2% compared with 4.9% for non-anaesthesia devices (P < 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)

Anesthesiology↗
PubMed1989

The accumulation of organotins in adult and seed oysters from selected estuaries prior to the introduction of U.K. regulations governing the use of tributyltin-based antifouling paints.

Between April and November, 1985, a study of the levels of organotins in adult and seed Crassostrea gigas grown in the southwest and southeast of England was carried out. This work corresponds with a similar study of organotin water levels (reported separately). The analytical procedure used was directly coupled high performance liquid chromatography-flame atomic absorption spectrometry. Individual adult oysters and groups of 20-40 seed oysters were taken for analysis on a monthly basis. The profiles of tributyltin (TBT), dibutyltin (DBT) and monobutyltin (MBT) are discussed in relation to each other and levels found in the waters. In general, levels of all three organotin species were found to be higher in the seed oysters. Mean levels of TBT reached 3.1 micrograms g-1 in seed oysters from the Exe, Devon, in October, whereas mean levels of DBT and MBT reached 16.1 and 16.7 micrograms g-1 in Teign, Devon, seed oysters in October. Bioconcentration factors of approximately 1000 were found, but seem to be greater when lower levels of TBT were present in the water, perhaps indicating a more 'efficient' removal from the water. The degree of shell thickening was calculated for all oysters submitted for analysis. The highest percentage of adult oysters with severely thickened shells was found at Tollesbury Fleet, where 61% of oysters showed shell thickness index values of six or less. Generally, two peaks in TBT levels in the oysters were observed, in the late spring and early summer: these seem to correlate with peak levels of TBT in the waters immediately preceding these times. A large proportion of the DBT and MBT found in the oysters seems to come from the metabolism of the TBT ingested. It is suggested that high sediment loadings may contribute to the severe deformation of oysters grown at Tollesbury Fleet, but only in the presence of TBT.

Aging↗