Determining Linezolid's baseline in vitro activity in Canada using gram-positive clinical isolates collected prior to its national release.
(49/767)
All of the isolates of Staphylococcus aureus (n = 317), Enterococcus species (n = 315), Streptococcus pneumoniae (n = 282), and Staphylococcus epidermidis (n = 176) collected at 16 Canadian microbiology laboratories from October 2000 to April 2001 were susceptible to linezolid. Future studies will determine how linezolid clinical use in Canada affects its in vitro activity. (+info)
New drug and biological drug products; evidence needed to demonstrate effectiveness of new drugs when human efficacy studies are not ethical or feasible. Final rule.
(50/767)
The Food and Drug Administration (FDA) is amending its new drug and biological product regulations to allow appropriate studies in animals in certain cases to provide substantial evidence of the effectiveness of new drug and biological products used to reduce or prevent the toxicity of chemical, biological, radiological, or nuclear substances. This rule will apply when adequate and well-controlled clinical studies in humans cannot be ethically conducted and field efficacy studies are not feasible. In these situations, certain new drug and biological products that are intended to reduce or prevent serious or life-threatening conditions may be approved for marketing based on evidence of effectiveness derived from appropriate studies in animals and any additional supporting data. (+info)
Digoxin products for oral use; revocation of conditions for marketing. Final rule.
(51/767)
The Food and Drug Administration (FDA) is revoking the regulation establishing conditions for marketing digoxin products for oral use. This regulation is no longer necessary because the products, which are new drugs, can be regulated under the approval process for new drug applications (NDAs) and abbreviated new drug applications (ANDAs) as set forth in the Federal Food, Drug, and Cosmetic Act (the act). (+info)
Food and Drug Administration approval of a fifth acellular pertussis vaccine for use among infants and young children--United States, 2002.
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On May 14, 2002, the Food and Drug Administration (FDA) approved for use an additional combined diphtheria and tetanus toxoids and acellular pertussis vaccine (DTaP) (DAPTACEL Aventis Pasteur, Ltd. [Toronto, Ontario]) for the first 4 doses of the diphtheria and tetanus toxoids and pertussis vaccination (DTP) series administered to infants and children aged 6 weeks-6 years (before seventh birthday). DAPTACEL is the fifth acellular pertussis vaccine to be licensed for use among infants and young children in the United States. Of these five, three (Tripedia, Infanrix, and DAPTACEL) are distributed in the United States. (+info)
International Conference on Harmonisation; choice of control group and related issues in clinical trials; availability. Notice.
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The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "E10 Choice of Control Group and Related Issues in Clinical Trials." 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 sets forth general principles that are relevant to all controlled trials and are especially pertinent to the major clinical trials intended to demonstrate drug (including biological drug) efficacy. The guidance describes the principal types of control groups and discusses their appropriateness in particular situations. The guidance is intended to assist sponsors and investigators in the choice of control groups for clinical trials. (+info)
International Conference on Harmonisation; guidance on S7A safety pharmacology studies for human pharmaceuticals; availability. Notice.
(54/767)
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.
(55/767)
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.
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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)