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FDA Issues Guidance On Levothyroxine Sodium Products Compliance
To reassure the millions of Americans now taking levothyroxine medications, the Food and Drug Administration yesterday published a guidance for industry explaining how the agency plans to handle oral levothyroxine sodium products that are being marketed without an approved application after 14 August 2001. more
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Parents Play A Role In A Child's Susceptibility To Allergies And Asthma
Events occurring in utero could influence the development of allergic immunity. Puppies from sensitized parents showed significantly higher ragweed-specific IgE levels, but lower ragweed specific IgG levels in serum in contrast to the offspring from non-sensitized dogs. Changes in airway resistance following a challenge of histamine or ragweed were significantly higher in dogs produced from sensitized parents. more
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Oligodeoxynucleotides May Prevent Allergic Rhinosinusitis, Lead To New Treatments For Allergies
CpG Oligodeoxynucleotides (ODN) may lead to new therapies for allergic rhinosinusitis, according to a study presented Friday at the third triennial World Asthma Meeting (WAM). Allergic rhinosinusitis is an immune-mediated processes of the upper airway characterized by Th2 cytokine-mediated eosinophilic inflammation. more
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Interrupting Stat6 (Signal Transducer And Activation Of Transcription Factor 6) May Provide New Asthma Therapy
Interrupting Stat6 (signal transducer and activation of transcription factor 6) may present an opportunity for a new asthma therapy, according to researchers at the World Asthma Meeting. more
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Guidance For Industry: Levothyroxine Sodium Products Enforcement of 14 August 2001 Compliance Date And Submission Of New Applications
On 14 August 1997, FDA announced in the Federal Register (62 FR 43535) that orally administered levothyroxine sodium drug products are new drugs. The notice stated that by 14 August 2000, manufacturers who wish to continue to market these products must obtain approved applications as required by section 505 of the Federal Food, Drug, and Cosmetic Act (the Act) and 21 CFR part 314. The notice stated that after 14 August 2000, any orally administered drug product containing levothyroxine sodium that is introduced or delivered for introduction into interstate commerce without an approved application will be subject to regulatory action, unless found by FDA to be not subject to the new drug requirements of the Act under a citizen petition submitted for that product. On 26 April 2000, FDA issued a second Federal Register notice (65 FR 24488) extending the deadline for obtaining approved applications until 14 August 2001. more
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