European regulatory policies on medicines and public health needs.
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The establishment of the EMEA has been a revolutionary step in the European pharmaceutical system. The 15 Member States of the European Union now share a common system for the evaluation of new medicinal products entering the European market. The decisions taken apply to the whole EU, with important implications for both industry and patients who may benefit from new therapies. The main immediate consequences of this system are: i) the time and effort saved by Member States in the evaluation of new drug applications; ii) more consistent and quicker availability of medicines in EU countries; iii) the establishment of a homogeneous regulatory policy throughout the EU. Public health has been presented as the fundamental concern of the EMEA, the mission statement of which is 'to promote the protection of human health ... and of consumers of medicinal products'. However, we note that there are some inconsistencies with this objective and the current system, such as those regarding drug trial requirements and the institutional location and financing of the EMEA. In this paper, some aspects of the new system are reviewed and consideration given as to how they relate to public health needs. Proposals are made for debate alternatives and improvements to the present system that would better respond to patients' health needs. (+info)
Implementation of the Methamphetamine Anti-Proliferation Act; thresholds for retailers and for distributors required to submit mail order reports; changes to mail order reporting requirements. Final rule.
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This regulation implements the new threshold requirements and mail order reporting requirements of the Methamphetamine Anti-Proliferation Act of 2000 (MAPA), which was enacted on October 17, 2000. DEA is amending its regulations to reduce the thresholds for pseudoephedrine and phenylpropanolamine for retail distributors and for distributors required to submit mail order reports. Also, DEA is amending its regulations to require mail order reports for certain export transactions. DEA is codifying exemptions from the mail order reporting requirements for certain distributions to nonregulated persons and certain export transactions. This rule is consistent with the intent of MAPA to prevent the diversion of drug products to the clandestine manufacture of methamphetamine and amphetamine, and simultaneously reduce the industry reporting burden. (+info)
Iron-containing supplements and drugs; label warning statements and unit-dose packaging requirements; removal of regulations for unit-dose packaging requirements for dietary supplements and drugs. Final rule; removal of regulatory provisions in response to court order.
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The Food and Drug Administration (FDA) is removing, in part, a final rule that required unit-dose packaging for iron-containing dietary supplement and drug products that contain 30 milligrams (mg) or more of iron per dosage unit. FDA is taking this action in response to the Court's ruling in Nutritional Health Alliance v. FDA, in which the Court concluded that the Federal Food, Drug, and Cosmetic Act (the act) does not provide FDA with authority to require manufacturers of iron-containing dietary supplement and drug products to use unit-dose packaging for poison prevention purposes. Today's action takes the ministerial step of removing the unit-dose packaging provisions from title 21 of the Code of Federal Regulations. (+info)
Herbal creams used for atopic eczema in Birmingham, UK illegally contain potent corticosteroids.
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AIMS: To determine whether "herbal creams" reported as being effective for the treatment of childhood atopic eczema contained corticosteroids. METHODS: Patients attending the paediatric dermatology clinic at Birmingham Children's Hospital, April 2001 to March 2002, and who reported using "herbal creams" with good effect for atopic eczema were asked to submit the cream for analysis. Hydrocortisone, clobetasone butyrate, betamethasone valerate, and clobetasol propionate were analysed by HPLC. RESULTS: Twenty four creams from 19 patients, median (interquartile range) age 3.82 (0.69-7.98) years were analysed. All five creams labelled Wau Wa and the two labelled Muijiza cream contained clobetasol propionate. Thirteen of 17 unnamed creams contained corticosteroids: clobetasol proprionate (n = 4), clobetasol proprionate + hydrocortisone (n = 1), betamethasone valerate (n = 2), clobetasone butyrate (n = 3), and hydrocortisone (n = 2); there was an unidentified peak in one. Further analysis suggested Wau Wa cream contained approximately 20% proprietary Dermovate Cream in a paraffin base. No parents were aware that the creams contained steroid. CONCLUSIONS: The majority of herbal creams analysed illegally contained potent or very potent topical steroids. There is an urgent need for tighter regulation of herbal creams and for increased public education about the potential dangers of alternative therapies. (+info)
Requirements for submission of labeling for human prescription drugs and biologics in electronic format. Final rule.
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The Food and Drug Administration (FDA) is amending its regulations governing the format in which certain labeling is required to be submitted for review with new drug applications (NDAs), certain biological license applications (BLAs), abbreviated new drug applications (ANDAs), supplements, and annual reports. The final rule requires that certain labeling content be submitted electronically in a form that FDA can process, review, and archive. Submitting the content of labeling in electronic format will simplify the drug labeling review process and speed up the approval of labeling changes. (+info)
Basis for regulation of selenium supplements in animal diets.
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Selenium was discovered 174 yr ago but, until 1957, was given little notice by biologists or was vilified as an agent that caused toxicity in grazing ruminants and horses in the northern Great Plains. After its status as an essential nutrient was established, Se received intense scrutiny, and hundreds of papers have been published dealing with its metabolic functions and the consequences of a Se deficiency. Because regions of Se deficiency are so extensive in the United States, great efforts have been made to gain Food and Drug Administration (FDA) approval for Se supplementation of animal diets. Initially, these efforts were thwarted by concern that Se might be carcinogenic. After this concern was resolved, researchers established supplemental Se levels that were efficacious, safe for animals, safe for humans that eat animal products, and protective of the environment. First approval of Se supplements was given in 1974 for supplementation of swine or growing chicken diets at .1 ppm. Supplements for turkey diets were approved at .2 ppm. Ultimately, in 1987, levels of supplemental Se in diets for chickens, turkeys, ducks, swine, sheep, and cattle were approved at .3 ppm. However, FDA regulations do not mention horses or zoo animals, and those who would ensure the welfare of these species by supplementing Se-deficient diets may be in violation of FDA interpretation of the law. In addition, the association of Se with death and deformities in aquatic birds at the Kesterson Reservoir in California has led to pressure on the FDA to reverse the 1987 amendments to the feed additive regulation.(ABSTRACT TRUNCATED AT 250 WORDS) (+info)
Biological products; bacterial vaccines and toxoids; implementation of efficacy review. Final rule and final order.
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The Food and Drug Administration (FDA) is amending the biologics regulations in response to the report and recommendations of the Panel on Review of Bacterial Vaccines and Toxoids with Standards of Potency (the Panel). The Panel reviewed the safety, efficacy, and labeling of bacterial vaccines and toxoids that have standards of potency, bacterial antitoxins, and immune globulins. On the basis of the Panel's findings and recommendations, FDA is classifying these products as Category I (safe, effective, and not misbranded), Category II (unsafe, ineffective, or misbranded), or Category IIIB (off the market pending completion of studies permitting a determination of effectiveness). (+info)
Medicaid program; time limitation on record keeping requirements under the drug rebate program. Interim final rule with comment period.
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On August 29, 2003, we published a final rule with comment period in the Federal Register that finalized two specific provisions: it established new 3-year recordkeeping requirements for drug manufacturers under the Medicaid drug rebate program and set a 3-year time limitation during which manufacturers must report changes to average manufacturer price and best price for purposes of reporting data to us. In addition, it announced the pressing need for codification of fundamental recordkeeping requirements. On September 26, 2003, we issued a correction notice to change the effective date of the August 29, 2003 rule from October 1, 2003 to January 1, 2004. In this interim final rule with comment period, we are removing the 3-year recordkeeping requirements, replacing them with 10-year recordkeeping requirements on a temporary basis, and soliciting comments on the 10-year requirements. Manufacturers must retain records beyond the 10-year period if the records are the subject of an audit or a government investigation of which the manufacturer is aware. These provisions contain a sunset date with respect to the record retention requirements to ensure that we reexamine whether the retention rule remain necessary and effective. This interim final rule with comment period also responds to public comments on the August 29, 2003 final rule with comment period that pertain to the 3-year recordkeeping requirement at Sec. 447.534(h). (+info)