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CCH NetNews™ |
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(June 29, 2010)
Food and Drug Law |
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A draft document that outlines the general approach proposed for development of a comprehensive data standards program in the FDA’s Center for Drug Evaluation and Research (CDER) was published by the agency for comments. Titled "CDER Data Standards Plan Version 1.0", the draft plan identifies: (1) key objectives for a data standards program at CDER; (2) processes to be developed to ensure successful use of those standardized data; and (3) a set of recommended projects to begin in calendar year 2010. According to the FDA, the current lack of standardized data affects CDER’s review processes by limiting a reviewer’s ability to perform integral tasks such as rapid acquisition, analysis, storage, and reporting of regulatory data. Standardized data will allow reviewers to increase review consistency and perform evaluations across the drug lifecycle. Submit either electronic or written comments on the draft plan by September 15, 2010.
FDA Notice.Read IRN» (ip access user) » (Read Intelliconnect) »
April 27, 2010, was confirmed by the FDA as the effective date for a final rule amending the color additive regulations to increase the permitted use level of bismuth citrate as a color additive in cosmetics intended for coloring hair on the scalp. Originally filed in a petition by Combe Inc., c/o EAS Consulting Group, LLC, 1940 Duke St., suite 200, Alexandria, VA 22314, the amended regulations will increase the level of bismuth citrate in cosmetics intended for coloring scalp hair to 2.0 percent (w/v). To show that the requested increased use level of bismuth citrate would be safe, Combe, Inc., provided results from a 90-day oral toxicity study on bismuth citrate in rats, genotoxicity studies, dermal penetration studies, and dermal photosensitization studies. The dermal penetration studies showed no evidence of detectable systemic absorption of bismuth citrate, and the in vitro (pig skin) dermal penetration study revealed only minimal absorption in the epidermis. The agency received no objections or requests for a hearing on the final rule.
FDA Notice.Read IRN» (ip access user) » (Read Intelliconnect) »
Seven Emergency Use Authorizations (EUAs), two of which were amended after initial issuance, for in vitro diagnostic devices were issued by the FDA because of the public health emergency involving Swine Influenza A (H1N1 flu). The EUAs contain conditions on the emergency use of the authorized in vitro diagnostics and include explanations of the reasons for their issuance or reissuance. The EUAs authorize: (1) ViraCor 2009 H1N1 Influenza A Real-time RT– PCR test issued on January 21, 2010; (2) ELITech Molecular Diagnostics 2009–H1N1 Influenza A virus Real-Time RT–PCR test issued on November 13, 2009, as amended and reissued in its entirety on February 1, 2010; (3) Longhorn Influenza A/H1N1–09 Prime RRT–PCR Assay issued on February 16, 2010, as amended and reissued in its entirety on March 23, 2010; (4) Diagnostic Hybrids, Inc. D3 Ultra 2009 H1N1 Influenza A Virus ID Kit issued on February 16, 2010; (5) artus® Inf. A H1N1 2009 LC RT–PCR Kit issued on March 11, 2010; (6) IMDx 2009 Influenza A H1N1 Real-Time RT– PCR Assay issued on March 22, 2010; and (7) Liat Influenza A/2009 H1N1 Assay issued on May 4, 2010. Further information on the EUAs were contained in the notice.
FDA Notice.Read IRN» (ip access user) » (Read Intelliconnect) »
On June 15, 2010, a source of information for patients and health care professionals on the safety of recently approved drugs and biologics was made available on the FDA website to provide periodically prepared summaries of the agency’s safety analyses on recently approved products, as well as brief discussion of the steps the agency would undertake to address any identified safety issues. Initial summary reports will contain information on drugs and biologics approved since September 2007, including several drugs for infections, hypertension, depression and other conditions. The summaries will provide safety data early in the product’s post-approval life cycle and will be based on numerous sources including reports to the FDA’s Adverse Event Reporting System by: (1) manufacturers; (2) providers; and (3) consumers. The summaries will also include a brief discussion of any steps the FDA may be or is taking to address any noted safety issues.
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