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TXT CDER Regulatory Science Research Priorities [384 Words] [ Price : $8.95]
CDER outlines five generic drug regulatory science priorities that will help generic drugs get to market faster.
08/15/2014
 
 
TXT FDA Wants Extra Study for Acura Hydrocodone Product [155 Words] [ Price : $8.95]
FDA asks Acura Pharmaceuticals for an additional nasal abuse liability study on its Aversion hydrocodone with acetaminophen tablets.
08/15/2014
 
 
TXT FDA Seeks Device Development Tools Pilot Participants [350 Words] [ Price : $8.95]
FDA looks for nominations for participants in a voluntary Medical Device Development Tools pilot program intended to improve the development and evaluation of scientific evidence by manufacturers and the agency.
08/14/2014
 
 
TXT Fraudulent Ebola Treatments Online: FDA [276 Words] [ Price : $8.95]
FDA says consumers should be aware that despite Internet claims to the contrary, there are no approved vaccines or drugs for Ebola available online or elsewhere.
08/14/2014
 
 
TXT Guidance on Drug/Biologic Clinical Pharmacology Labeling [134 Words] [ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance: Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products Considerations, Content, and Format.
08/14/2014
 
 
TXT Guidance on Device De Novo Classification [120 Words] [ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance for medical devices: De Novo Classification Process (Evaluation of Automatic Class 3 Designation).
08/14/2014
 
 
TXT Comments Reopened on Drug Naming Practices [46 Words] [ Price : $8.95]
Federal Register Notice: FDA reopens the comment period for a draft guidance on best practices in developing proprietary names for drugs.
08/14/2014
 
 
TXT Workshop on Preventing Staphylococcus aureus [124 Words] [ Price : $8.95]
Federal Register Notice: FDA plans a public workshop 9/5 on the clinical development of drugs for preventing serious infections caused by Staphylococcus aureus in the health care setting.
08/14/2014
 
 
TXT FDA Corrects Rule on Drug/Biologic Safety Reports [76 Words] [ Price : $8.95]
Federal Register Notice: FDA corrects a 6/10 final rule on postmarketing safety reports for human drug and biological products.
08/14/2014
 
 
TXT Drug Products Not Withdrawn for S&E [69 Words] [ Price : $8.95]
Federal Register Notice: FDA determines that several drug products were not withdrawn from sale for reasons of safety or effectiveness.
08/14/2014
 
 
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