Big Chemical Encyclopedia

Chemical substances, components, reactions, process design ...

Articles Figures Tables About

U.S. Pharmaceutical Manufacturers Association

The scope of the computer system being validated must be clearly imderstood. Computer systems can be thought of as comprising a programmable electronic device that may be connected to actuators and sensors (and possibly other computer systems) via communication links. Closely associated with the computer system are data and equipment, people, and procedures. A schematic of a computer-related system based on some work by the U.S. Pharmaceutical Manufacturers Association (PMA) is shown in Figure 6.1. [Pg.125]

In 1991, the Commission of European Communities, the FDA, the Japanese Ministry of Heath and Welfare, the International Federation of Pharmaceutical Manufacturers Associations, the European Federation of Pharmaceutical Manufacturers Associations, the U.S. Pharmaceutical Manufacturers Association and the Japanese Pharmaceutical Manufacturers Association organized the first International Conference on Harmonization (ICH). The goal of the conference was to begin to harmonize requirements for regulatory submissions in the United States, Europe and Japan in the areas of quality, safety, and efficacy. One of the quality topics was stability testing. [Pg.443]

In 1990, the U.S. Pharmaceutical Manufacturers Association (now called PhRMA) formed a committee to define BPC validation concepts (2). This committee s efforts culminated in 1995 when they issued their finished draft. This document served as a guide to the authors in the development of this chapter. Of necessity, considerable clarification and expansion of the material contained has been necessary to complete this effort. [Pg.204]

U.S. Research", Pharmaceutical Manufacturers Association (PMA) Bulletin, (July 1978) 5. [Pg.42]

Trends in U.S. Pharmaceutical Sales and R D 1990-93 PMA Annual Survey Report, Pharmaceutical Manufacturers Association. Washington, DC. 1993. Walsh, G. Biopharmaceuticals Biochemistry and Biotechnology. 2nd Edition, John Wiley Sons. Inc., New York, NY, 2003. [Pg.1265]

One of the key elements for its success is most probably the composition of the organization. It was founded in 1990 as a joint regulatory/industry initiative. The six cosponsors are the EC and the EFPIA (European Federation of Pharmaceutical Industries Association) for the EU, the MHLW and JPMA (Japan Pharmaceutical Manufacturers Association) for Japan, and the U.S. FDA and PhRMA (Pharmaceutical Research and Manufacturers of America) for the United States. [Pg.863]

The ICH Committee consists of the European Commission of the European Union (EU), the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Ministry of Health and Welfare, Japan (MHW), the Japan Pharmaceutical Manufacturers Association (JPMA), the U.S. [Pg.120]

International Conference on Harmonisation (ICH) The ICH was formed to provide an opportunity for tripartite harmonization initiatives to be developed with input from both regulatory and industry representatives. The ICH is sponsored by the European Commission, the European Federation of Pharmaceutical Industry Associations, the Japanese Ministry of Health and Welfare, the Japanese Pharmaceutical Manufacturers Association, the U.S. Food and Drug Administration, and the Pharmaceutical Research and Manufacturers of America. The objective of the ICH is to harmonize the technical requirements for the registration of pharmaceutical products in the European Union, Japan, and the United States. [Pg.480]

The Pharmaceutical Manufacturers Association (PMA) is the main source of industry trade data on R D conducted in the United States by its member companies and abroad by its U.S.-based businesses.1 PMA publishes an annual survey of its 60 corporate members, representing about 100 business entities. [Pg.39]

KEY NCE- new chemical entity IND - investigational new drug FDA - U.S. Food and Drug Administration PMA- Pharmaceutical Manufacturers Association. [Pg.49]

The Pharmaceutical Manufacturers Association (PMA) collects sales data of its member firms in an annual survey. U.S.-owned PMA member firms reported that the ratio of total worldwide sales to domestic sales was 1.765 to 1 in 1990 (317). These companies are likely to have a lower percent of sales outside the United States than are foreign-owned firms that launch new products in the United States, and the ratio is based on drugs that have lost patent protection as well as those that are covered by patents. Thus, this ratio is too conservative. [Pg.89]

Eisman, M.M., and Warden, W. M., Incremental Time Study An Analysis of Time Spent in the Development and Approval of Drugs for the U.S. Market, Economic Costs of FDA Regulations y Pharmaceutical Manufacturers Association (ed.)(Washington, DC Pharmaceutical Manufacturers Association, 1981). [Pg.328]

Pharmaceutical Manufacturers Association, 1989-1991 Statistical Report The U.S. Pharmaceutical Industry, (Washington, DC Pharmaceutical Manufacturers Association, 1991). [Pg.336]

Thalidomide, a new sedative, was associated with birth defects in thousands of newborns throughout Europe. Fortunately, the medication had not been approved for use within the U.S. In 1962, with the support of Senator Estes Kefauver, another health policy window was opened the amendments were passed to ensure that medications were both safe and efficacious. With the Kefauver-Harris Amendments, the effectiveness of a medication has to be proven by substantial evidence which includes adequate and well-controlled trials. For the first time, pharmaceutical manufacturers had to demonstrate a product s efficacy to the FDA. The Kefauver-Harris Amendments led the way for randomized clinical trials and the FDA drug approval process. [Pg.349]


See other pages where U.S. Pharmaceutical Manufacturers Association is mentioned: [Pg.272]    [Pg.254]    [Pg.272]    [Pg.226]    [Pg.143]    [Pg.272]    [Pg.254]    [Pg.272]    [Pg.226]    [Pg.143]    [Pg.223]    [Pg.844]    [Pg.248]    [Pg.67]    [Pg.355]    [Pg.25]    [Pg.1788]    [Pg.273]    [Pg.6]    [Pg.137]    [Pg.288]    [Pg.1096]    [Pg.256]    [Pg.223]    [Pg.404]    [Pg.346]    [Pg.450]    [Pg.751]    [Pg.361]    [Pg.179]    [Pg.72]    [Pg.64]    [Pg.99]    [Pg.203]    [Pg.423]    [Pg.798]    [Pg.375]    [Pg.8]    [Pg.308]    [Pg.221]   
See also in sourсe #XX -- [ Pg.143 ]




SEARCH



Pharmaceutical Association

Pharmaceutical Manufacturers

Pharmaceutical Manufacturers Association

Pharmaceutical manufacture

Pharmaceuticals manufacturing

U.S. manufacturers

US,ASSOCIATION

© 2024 chempedia.info