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FDA proposes a rule to specify clarified postmarketing safety reporting requirements for combination products.[ Price : $8.95]
Mylan asks FDA to not approve any fentanyl transdermal products containing a substantially higher drug load than current patches.[ Price : $8.95]
EMD Serono has submitted an NDA to FDA for cladribine tablets for therapy to reduce relapses in people with relapsing forms of mul...[ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information on humanitarian device exemption regulations to the Offi...[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Arjo Med, Banyan Botanicals, Bioniche Pharma, Ion Labs, John Kirkwood, and Netpr...[ Price : $8.95]
Federal Register Notice: FDAs Anti-Infective Drugs Advisory Committee will meet 10/26 to discuss updating susceptibility test info...[ Price : $8.95]
BIO raises a number of questions and clarification requests on FDAs draft ICH genomic biomarker guidance.[ Price : $8.95]
Federal Register Notice: FDAs Blood Products Advisory Committee will meet 11/16-17 to discuss various topics such as the 2009 A/H1...