International Conference on Harmonisation; guidance on S7A safety pharmacology studies for human pharmaceuticals; availability. Notice.
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The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "S7A Safety Pharmacology Studies for Human Pharmaceuticals." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides a definition, general principles, and recommendations for the nonclinical safety pharmacology studies. The guidance is intended to help protect clinical trial participants and patients receiving marketed products from potential adverse effects of pharmaceuticals, while avoiding unnecessary use of animals and other resources. (+info)
International Conference on Harmonisation; guidance on M4 common technical document; availability. Notice.
(42/811)
The Food and Drug Administration (FDA) is announcing the availability of guidance entitled "M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use" (M4CTD). The guidance was developed under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance, which is being made available simultaneously in four parts (general organization, quality, safety, and efficacy), describes a harmonized format for new product applications (including applications for biotechnology-derived products) for submission to the regulatory authorities in the three ICH regions. The M4 CTD is intended to reduce the time and resources used to compile applications, ease the preparation of electronic submissions, facilitate regulatory reviews and communication with the applicant, and simplify the exchange of regulatory information among regulatory authorities. (+info)
International Cooperation on Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products (VICH); final guidance for industry on "studies to evaluate the safety of residues of veterinary drugs in human food: genotoxicity testing" (VICH GL23); availability. Notice.
(43/811)
The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry (116) entitled "Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food:Genotoxicity Testing" (VICH GL23). This final guidance has been adapted for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products(VICH) from a guidance regarding pharmaceuticals for human use, which was adopted by the International Conference on Harmonisation of Technical Requirements for Approval of Pharmaceuticals for Human Use (ICH). This final VICH guidance document recommends a basic battery of tests that can be used to evaluate the genotoxicity of veterinary drug residues in human food in the European Union, Japan, and the United States (+info)
International Cooperation on Harmonisation of Technical requirements for Approval of Veterinary Medicinal Products (VICH); final guidance on " Safety studies for veterinary drug residues in human food: reproduction toxicity testing" (VICH GL22); availability. Notice.
(44/811)
The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry (#115) entitled "Safety Studies for Veterinary Drug Residues in Human Food: Reproduction Toxicity Testing"(VICH GL22). This final guidance has been adapted for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) from a guidance regarding pharmaceuticals for human use, which was adopted by the International Conference on Harmonisation of Technical Requirements for Approval of Pharmaceuticals for Human Use (ICH). This final VICH guidance document recommends a basic battery of tests that can be used to evaluate the reproduction safety of veterinary drug residues in human food. (+info)
The role of the UKEMS in the development of testing guidelines.
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Twenty years ago UKEMS established a sub-committee to determine the minimal professional criteria that should be achieved to comply with mutagenicity testing requirements in the UK. Recommendations on the conduct of basic and supplementary tests were published in 1983 and 1984, respectively. Despite their local distribution, these recommendations had an impact around the world. Further guidelines for statistical evaluation of mutagenicity test data and revisions to the first two volumes followed. By the early 1990s the mood was for international harmonization rather than national or regional isolation. The processes by which UKEMS had achieved its testing recommendations in the 1980s and early 1990s were successfully employed in the International Workshops for Genotoxicity Testing, of which three have now been held, and made a significant impact on OECD guidelines and ICH guidance. Summary outcomes from the latest meeting (2002 Plymouth Workshop) are given. (+info)
1975 to 1984--an important decade for peritoneal dialysis: memories with personal anecdotes.
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That decade, 1975 to 1984, saw many important events in the history of PD, including (1) the beginnings of CAPD; (2) the performance in Canada of CAPD with solutions in bags; (3) the First International Peritoneal Dialysis Symposium, in Mexico, preceding all the symposia and congresses to follow; (4) the approval of solutions in bags and CAPD Medicare reimbursement in the USA; (5) the start of the NIH CAPD Registry, probably setting the groundwork for the USRDS; (6) the First Annual CAPD Conference, beginning 23 years of consecutive conferences; (7) the start of the Peritoneal Dialysis Bulletin, which later became Peritoneal Dialysis International; and (8) the formation of the ISPD. One hopes those caring for patients on chronic PD will remember the ideas and hopes of this period and build on them into the distant future. In my opinion, the new ideas, the clinical and laboratory studies, and the experiences shared during this exciting time not only advanced PD and its results, but also had a positive impact on our understanding of uremia and improved the quality of care and results obtained with all renal replacement therapies. (+info)
International Conference on Harmonisation: guidance on Q1D bracketing and matrixing designs for stability testing of new drug substances and products; availability. Notice.
(47/811)
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This guidance is an annex to an ICH guidance entitled "Q1A(R) Stability Testing of New Drug Substances and Products" (66 FR 56332, November 7, 2001). It is intended to provide guidance on the application of reduced designs (i.e., bracketing and matrixing) for stability studies conducted in accordance with the principles outlined in ICH Q1A(R). (+info)
Mass media release of medical research results: an analysis of antihypertensive drug prescribing in the aftermath of the calcium channel blocker scare of March 1995.
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BACKGROUND: Disclosure of medical research results to the public creates tension between lay medical reporters and the medical profession. OBJECTIVE: To explore the early effect of media attention on the risks associated with short-acting calcium channel blockers (CCBs) for treating hypertension after publication at a national meeting and following publication. DESIGN: Time-series analysis of prescription claims data. SETTING AND DATA SOURCE: National third-party pharmaceutical benefits manager. PATIENTS: Employed or retired persons and their families, 18 years of age or older, receiving prescription benefits from 1 of 4 national companies that contracted with the pharmaceutical benefits manager exclusively for prescription drug coverage. MEASUREMENTS: Prescription claims for antihypertensive drugs by fill date converted to a percentage of all cardiovascular drug claims. Data were grouped into weekly intervals before and immediately after the national release of negative information about CCBs on March 10, 1995 and following publication of the results on August 23, 1995. RESULTS: The most prevalent antihypertensive drugs were diuretics (21% of cardiovascular prescription claims) and calcium channel blockers (19%). A 10% decline in prescriptions filled for CCBs occurred 4 weeks following the intense media attention. Only prescriptions for long-acting calcium channel blockers declined. Alpha-1-blocker prescriptions increased by approximately the same amount that prescriptions for CCBs declined, suggesting substitution of one drug for the other. Changes in diuretic or beta-blocker prescriptions filled were not statistically significant. No immediate change in other cardiovascular drug classes occurred following journal publication. CONCLUSIONS: Intense media publicity regarding a controversial study measurably and unpredictably changed prescription claims. (+info)