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Pepper Hamilton attorneys trace the evolution of FDA thinking on when a previously-approved compound could still receive NCE exclu...[ Price : $8.95]
FDA publishes an International Council on Harmonization draft guidance on microsampling in toxicokinetic animal studies.[ Price : $8.95]
CDRH denies a Germaine Laboratories petition that sought an exemption from premarket notification requirements for method, metalli...[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites American Pharmacy of Illinois, Central Illinois Compounding, Harrington House, K...[ Price : $8.95]
FDA grants EBR Systems an Investigational Device Exemption for its WiSE (Wireless Stimulation Endocardially) technology for cardia...[ Price : $8.95]
Federal Register notice: FDA releases a guidance on Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Viru...[ Price : $8.95]
FDA approves a Carl Zeiss Meditec PMA for the VisuMax Femtosecond Laser for the small incision lenticule extraction procedure to r...[ Price : $8.95]
FDA warns Harrington House that its Web site is selling unapproved new drugs.