Your Messages Inbox
Your Article Summary
See Latest ArticlesFDA Embraces a New Review Process and Approves SNMs Multi-center IND
Applied Clinical Trials, 02/03/09
SNM announced FDA approval of an SNM-sponsored centralized multi-center investigational new drug (IND) application for 18F-labeled 3'-deoxy-3'-fluorothymidine (FLT). The approval of multi-center Chemistry Manufacturing and Controls (CMC) in the FLT IND represents the successful demonstration of an important FDA IND review process for positron emission tomography (PET) imaging biomarkers. The FDA has agreed to allow multiple sources of FLT to be evaluated, reviewed and accepted for use under a single IND. FDA has also agreed to base the IND review process for acceptance of the various investigational FLT products on the end product specifications.
Today in Drug/Product Approvals...keeping you current
Receive free subspecialty "5-minute updates" via email
Zoster vaccination: A new opportunity for adult immunization
Canadian Journal of Infectious Diseases, 12/15/09
FDA Approves Newly Revised Prescribing Information For Azilect Reducing Medication And Food Restrictions
Teva Pharmaceutical Industries, 12/15/09
Mylan Receives Approval for Generic Version of Antiepileptic Keppra 1000 mg
Mylan, 12/15/09
Article Search
Sponsor