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At least 19 recordsLinked to original sources
PubMed1998

Biological products regulated under Section 351 of the Public Health Services Act; implementation of biologics license; elimination of establishment license and product license--FDA. Proposed rule.

The Food and Drug Administration (FDA) is proposing to amend the biologics regulations to eliminate references to establishment licenses and product licenses for all products regulated under the Public Health Service Act (PHS Act). In lieu of filing an establishment license application (ELA) and product license application (PLA) in order to market a biological product in interstate commerce, a manufacturer would file a single biologics license application (BLA) with the agency. Upon approval of the BLA, a manufacturer would receive a biologics license to market the product in interstate commerce. This action is part of FDA's continuing effort to achieve the objectives of the President's "Reinventing Government" initiatives and is intended to reduce unnecessary burdens for industry without diminishing public health protection. This action also proposes regulations to implement certain sections of the Food and Drug Administration Modernization Act of 1997 (FDAMA).

Consumer Product Safety↗
PubMed1998

Biological products regulated under Section 351 of the Public Health Service Act; implementation of biologics license; elimination of establishment license and product license; public workshop--FDA. Proposed rule; notice of workshop.

The Food and Drug Administration (FDA) is announcing a public workshop to present issues related to the agency's proposed rule entitled "Biological Products Regulated Under Section 351 of the Public Health Service Act; Implementation of Biologics License; Elimination of Establishment License and Product License" issued recently in the Federal Register. The purpose of the public workshop is to provide interested persons an opportunity to more clearly understand the proposed rule and its effect on industry and the public.

Biological Products↗
PubMed1998

Biological products regulated under Section 351 of the Public Health Services Act; implementation of biologics license; elimination of establishment license and product license; correction--FDA. Proposed rule; correction.

The Food and Drug Administration (FDA) is correcting a proposed rule that appeared in the Federal Register of July 31, 1998 (63 FR 40858). The document proposed to amend the biologics regulations to eliminate references to establishment licenses and product licenses for all products regulated under the Public Health Services Act. The document published with an incorrect address. This document corrects that error.

Consumer Product Safety↗
PubMed1997

License term for medical use licenses--NRC. Proposed rule.

The U.S. Nuclear Regulatory Commission is proposing to amend 10 CFR part 35 to eliminate the five-year term limit for medical use licenses in 10 CFR 35.18. License terms for licenses issued pursuant to part 35 would be set, by policy up to ten years, as are the license terms for other materials licenses. The NRC would issue some licenses for shorter terms, if warranted by the individual circumstances of license applicants. The amendment would reduce the administrative burden of license renewals for both NRC and licensees, and would support NRC's goal of streamlining the licensing process.

Government Agencies↗
PubMed1998

License terms for medical use licenses--NRC. Final rule.

The Nuclear Regulatory Commission is amending its regulations pertaining to the medical use of byproduct material to eliminate the 5-year term limit for medical use licenses. License terms for licenses issued under these regulations will be set by policy. Other materials licenses are issued for up to 10 years. The NRC will issue some licenses for shorter terms if warranted by the individual circumstances of license applicants. The amendment reduces the administrative burden of license renewals on a 5-year cycle for both NRC and licensees and supports NRC's goal of streamlining the licensing process.

Environmental Health↗
PubMed1995

The New Zealand graduated driver licensing system: teenagers' attitudes towards and experiences with this car driver licensing system.

OBJECTIVES: This study examined the attitudes of teenagers towards the New Zealand graduated driver licensing system (GDLS), and the extent to which it affected them. METHOD: Teenagers, who are members of a longitudinal study of a birth cohort, were interviewed at 15 years of age when the GDLS was first introduced and before they had begun licensure, and again at 18 years of age after they had experience with this licensing system. RESULTS: At both ages the majority (over 70%) agreed with the driving restrictions imposed by this system. After experience with the restrictions, however, significantly more reported being affected a lot by them, than had expected to be at age 15. This was especially true of the restrictions on the carrying of passengers and the night time curfew (10 pm - 5 am). However, few reported that they were affected by the alcohol restriction. Sixty eight per cent of those with a graduated licence reported breaking at least one of the conditions, most frequently carrying passengers. Very few were penalised by the police for this. CONCLUSIONS: Generally these young drivers were positively disposed towards the driving restrictions, but noncompliance was common. A full evaluation of all aspects of this licensing system is recommended.

Accidents, Traffic↗
PubMed1997

Does licensing of drugs in industrialized countries guarantee drug quality and safety for Third World countries? The case of norplant licensing in Finland.

Norplant implantable contraceptives were developed mainly for use in Third World countries, but first were approved for marketing in Finland in 1983 and in Sweden in 1985. Since then Norplant has been approved in more than 40 countries, most of them in the Third World. The authors analyzed the clinical documentation submitted to the Finnish and Swedish drug control authorities, and the assessments made of the data. The Finnish review process lasted for three years, and the number of data increased substantially during that time. The authors have not been allowed to publish the clinical data submitted in Finland, but a reconstruction from the Swedish data showed that the clinical data were of poor quality and were mainly focused on assessing efficacy. Side effects, acceptability, and requirements of the health care system for proper use of Norplant were poorly studied. This example of Norplant licensing in Finland shows that licensing of drugs in industrialized countries is insufficient for guaranteeing their safety in Third World countries.

Contraceptive Agents, Female↗
PubMed1992

The relationship between license type and alcohol-related problems attributed to licensed premises in Perth, Western Australia.

Drink-driving offenses, alcohol-related traffic accidents and number of assault charges were used as indicators of the degree of alcohol-related problems associated with individual licensed premises in the Perth Traffic Police region of Western Australia. These indicators were used to rank five main categories of licensed premises according to the levels of harm experienced by their customers while controlling for the amounts of alcohol sold in each category. Nightclubs, taverns and hotels emerged as "high-risk" in comparison with clubs and restaurants. The role of such factors as different customer characteristics, opening hours, types of entertainment, restrictions on clientele and provision of meals are discussed as possible explanations underlying this finding.

Accidents, Traffic↗
PubMedDate not supplied

Integrating the licensed practical nurse and the licensed vocational nurse into the specialty of intravenous nursing.

In the scope of intravenous nursing practice, Licensed Practical Nurses (LPNs) and Licensed Vocational Nurses (LVNs) can competently perform specific IV therapy procedures after successfully completing a well-structured IV nursing continuing education process. This article provides an overview of the various processes that need to be employed to ensure IV nursing competency of LPNs and LVNs before effectively integrating them into the specialty of IV nursing.

Education, Nursing, Continuing↗
PubMedDate not supplied

The role of the licensed practical nurse and the licensed vocational nurse in the clinical practice of intravenous nursing. The Intravenous Nurses Society.

The Intravenous Nurses Society (INS) believes that the intravenous trained licensed practical nurse and the licensed vocational nurse can aid in the delivery of some aspects of intravenous therapy under the supervision of the registered nurse; however, the registered nurse shall be the primary practitioner in this specialty.

Humans↗