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Guidance on Self-Selection Studies for Non-Rx Drugs
[100 Words]
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Federal Register Notice: FDA releases a guidance on self-selection studies to support nonprescription drug product applications.
04/11/2013
Guidance on Device Product Codes
[59 Words]
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Federal Register Notice: FDA releases a guidance, Medical Device Classification Product Codes.
04/11/2013
Sales Reps Rarely Offer Adverse Event Info
[142 Words]
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Researchers say drug company sales representatives generally don’t provide sufficient adverse event information to prescribing doctors.
04/11/2013
Nonprescription Drug Self-Selection Study Guidance
[160 Words]
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FDA issues a guidance on consumer self-selection studies for nonprescription drug products.
04/11/2013
Concerns Raised on Electronic Source Data Draft Guidance
[349 Words]
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Several companies and organizations offer FDA suggestions for improving a draft guidance on electronic source data in clinical investigations.
04/11/2013
Journals Need Explicit Ghostwriting Policy: Study
[159 Words]
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Researchers say too few biomedical journals have explicit policies about ghostwritten articles.
04/11/2013
FDA Selects Disease Areas for Drug Development Initiative
[99 Words]
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Federal Register Notice: FDA selects 12 disease areas to address during its Patient-Focused Drug Development initiative.
04/11/2013
Praise, Questions for FDA’s Alzheimer’s Drug Guidance
[345 Words]
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Several drug companies and advocacy organizations express support for FDA’s draft guidance on developing new drugs to treat early-stage Alzheimer’s disease.
04/10/2013
Merck Seeks Approval for Noxafil Tablet Formulation
[91 Words]
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FDA accepts a Merck NDA for a tablet formulation of its antifungal agent Noxafil, which is currently approved as an oral suspension.
04/10/2013
Comments Sought on Info Collection on Tobacco Health Documents
[91 Words]
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Federal Register Notice: FDA seeks comments on tobacco health document submission.
04/10/2013
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