Suchergebnisse

The University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), in collaboration with the Food and Drug Administration (FDA), conducted research and outreach to solicit input from the public, including medical specialists, to better understand the use of certain bulk drug substances nominated for use in compounding by outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (the Act). In particular, we were interested in how drugs compounded with these bulk drug substances were used historically, and how they are currently used in clinical practice. The research will assist the FDA in its development of a list of bulk drug substances that outsourcing facilities can use in compounding under section 503B of the Act. Research for each bulk drug substance included a systematic literature review, interviews with medical experts and a survey of healthcare practitioners. Our findings for the nominated substance, Betamethasone sodium phosphate, were summarized in this report. ; U.S. Food and Drug Administration clinical use of bulk drug substances nominated for inclusion on the 503B Bulks List Grant number: #U01FD005946

The University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), in collaboration with the Food and Drug Administration (FDA), conducted research and outreach to solicit input from the public, including medical specialists, to better understand the use of certain bulk drug substances nominated for use in compounding by outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (the Act). In particular, we were interested in how drugs compounded with these bulk drug substances were used historically, and how they are currently used in clinical practice. The research will assist the FDA in its development of a list of bulk drug substances that outsourcing facilities can use in compounding under section 503B of the Act. Research for each bulk drug substance included a systematic literature review, interviews with medical experts and a survey of healthcare practitioners. Our findings for the nominated substance, Sodium phosphate USP, were summarized in this report. ; U.S. Food and Drug Administration clinical use of bulk drug substances nominated for inclusion on the 503B Bulks List Grant number: #U01FD005946

The University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), in collaboration with the Food and Drug Administration (FDA), conducted research and outreach to solicit input from the public, including medical specialists, to better understand the use of certain bulk drug substances nominated for use in compounding by outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (the Act). In particular, we were interested in how drugs compounded with these bulk drug substances were used historically, and how they are currently used in clinical practice. The research will assist the FDA in its development of a list of bulk drug substances that outsourcing facilities can use in compounding under section 503B of the Act. Research for each bulk drug substance included a systematic literature review, interviews with medical experts and a survey of healthcare practitioners. Our findings for the nominated substance, Dexamethasone sodium phosphate, were summarized in this report. ; U.S. Food and Drug Administration clinical use of bulk drug substances nominated for inclusion on the 503B Bulks List Grant number: #U01FD005946

The University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), in collaboration with the Food and Drug Administration (FDA), conducted research and outreach to solicit input from the public, including medical specialists, to better understand the use of certain bulk drug substances nominated for use in compounding by outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (the Act). In particular, we were interested in how drugs compounded with these bulk drug substances were used historically, and how they are currently used in clinical practice. The research will assist the FDA in its development of a list of bulk drug substances that outsourcing facilities can use in compounding under section 503B of the Act. Research for each bulk drug substance included a systematic literature review, interviews with medical experts and a survey of healthcare practitioners. Our findings for the nominated substance, Sodium phosphate monobasic anhydrous, were summarized in this report. ; U.S. Food and Drug Administration clinical use of bulk drug substances nominated for inclusion on the 503B Bulks List Grant number: #U01FD005946

The University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), in collaboration with the Food and Drug Administration (FDA), conducted research and outreach to solicit input from the public, including medical specialists, to better understand the use of certain bulk drug substances nominated for use in compounding by outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (the Act). In particular, we were interested in how drugs compounded with these bulk drug substances were used historically, and how they are currently used in clinical practice. The research will assist the FDA in its development of a list of bulk drug substances that outsourcing facilities can use in compounding under section 503B of the Act. Research for each bulk drug substance included a systematic literature review, interviews with medical experts and a survey of healthcare practitioners. Our findings for the nominated substance, riboflavin 5'-phosphate sodium, were summarized in this report. ; U.S. Food and Drug Administration Clinical use of bulk drug substances nominated for inclusion on the 503B Bulks List Grant number: 2U01FD005946

The University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), in collaboration with the Food and Drug Administration (FDA), conducted research and outreach to solicit input from the public, including medical specialists, to better understand the use of certain bulk drug substances nominated for use in compounding by outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (the Act). In particular, we were interested in how drugs compounded with these bulk drug substances were used historically, and how they are currently used in clinical practice. The research will assist the FDA in its development of a list of bulk drug substances that outsourcing facilities can use in compounding under section 503B of the Act. Research for each bulk drug substance included a systematic literature review, interviews with medical experts and a survey of healthcare practitioners. Our findings for the nominated substance, Betamethasone acetate, were summarized in this report. ; U.S. Food and Drug Administration clinical use of bulk drug substances nominated for inclusion on the 503B Bulks List Grant number: #U01FD005946

The University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), in collaboration with the Food and Drug Administration (FDA), conducted research and outreach to solicit input from the public, including medical specialists, to better understand the use of certain bulk drug substances nominated for use in compounding by outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (the Act). In particular, we were interested in how drugs compounded with these bulk drug substances were used historically, and how they are currently used in clinical practice. The research will assist the FDA in its development of a list of bulk drug substances that outsourcing facilities can use in compounding under section 503B of the Act. Research for each bulk drug substance included a systematic literature review, interviews with medical experts and a survey of healthcare practitioners. Our findings for the nominated substance, Betamethasone dipropionate, were summarized in this report. ; U.S. Food and Drug Administration clinical use of bulk drug substances nominated for inclusion on the 503B Bulks List Grant number: #U01FD005946

Vitamin C is essential for primates, guinea pigs and fish. Vitamin C, in the form of ascorbic acid and its calcium and sodium salts, ascorbyl palmitate, sodium calcium ascorbyl phosphate and sodium ascorbyl phosphate, is safe for all animal species. Setting a maximum content in feed and water for drinking is not considered necessary. Data on the vitamin C consumption of consumers are based on the levels of vitamin C in foodstuffs, including food of animal origin, produced in accordance with current EU legislation on the supplementation of feed with vitamin C. The exposure is far below the guidance level. Any potential contribution of the use of vitamin C in feed is therefore already considered in the above data. Consequently, the use of vitamin C in animal nutrition is not of concern for consumer safety. In the absence of inhalation toxicity studies it would be prudent to assume that inhalation of dust from the additives presents a health hazard to workers. Sodium calcium ascorbyl phosphate is not an irritant to skin and eyes and is unlikely to be a skin sensitiser. This conclusion is extrapolated to sodium ascorbyl phosphate. In the absence of data, ascorbic acid, sodium ascorbate, calcium ascorbate and ascorbyl palmitate should be considered as irritant to skin and eyes and as dermal sensitisers. The supplementation of feed with vitamin C does not pose a risk to the environment. Ascorbic acid, sodium calcium ascorbyl phosphate and sodium ascorbyl phosphate are regarded as effective sources of vitamin C when added to feed or water for drinking. Since ascorbic acid, sodium ascorbate, calcium ascorbate and ascorbyl palmitate are authorised for use as antioxidants in food and their function in feed is essentially the same as that in food, no further demonstration of efficacy is considered necessary.