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TXT Nonprescription Drug Self-Selection Study Guidance [160 Words] [ Price : $7.95]
FDA issues a guidance on consumer self-selection studies for nonprescription drug products.
04/11/2013
 
 
TXT Concerns Raised on Electronic Source Data Draft Guidance [349 Words] [ Price : $7.95]
Several companies and organizations offer FDA suggestions for improving a draft guidance on electronic source data in clinical investigations.
04/11/2013
 
 
TXT Journals Need Explicit Ghostwriting Policy: Study [159 Words] [ Price : $7.95]
Researchers say too few biomedical journals have explicit policies about ghostwritten articles.
04/11/2013
 
 
TXT FDA Selects Disease Areas for Drug Development Initiative [99 Words] [ Price : $7.95]
Federal Register Notice: FDA selects 12 disease areas to address during its Patient-Focused Drug Development initiative.
04/11/2013
 
 
TXT Praise, Questions for FDA’s Alzheimer’s Drug Guidance [345 Words] [ Price : $7.95]
Several drug companies and advocacy organizations express support for FDA’s draft guidance on developing new drugs to treat early-stage Alzheimer’s disease.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
 
 
TXT Merck Seeks Approval for Noxafil Tablet Formulation [91 Words] [ Price : $7.95]
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
 
 
TXT Comments Sought on Info Collection on Tobacco Health Documents [91 Words] [ Price : $7.95]
Federal Register Notice: FDA seeks comments on tobacco health document submission.
04/10/2013
 
 
TXT FDA Releases Alexion Inspection Report [134 Words] [ Price : $7.95]
FDA releases the FDA-483 detailing results of a 2012 inspection at an Alexion API facility that resulted in a Warning Letter.
04/10/2013
 
 
TXT Court Ruling May Speed FOIA Responses [370 Words] [ Price : $7.95]
Attorney Kurt Karst says a DC appeals court decision may help those seeking documents from FDA under the Freedom of Information Act to force the agency to move more quickly.
04/10/2013
 
 
TXT Company Asks for Delay in Warning Letter Publication [175 Words] [ Price : $7.95]
An unidentified company asks FDA not to publish a Warning Letter it received until the firm has exhausted its appeals and resolves other issues relating to contents of the letter.
04/10/2013
 
 
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