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TXT Device Consensus Standards Database Updated [132 Words] [ Price : $8.95]
FDA updates its recognized consensus standards database for medical devices.
08/03/2020
 
 
TXT Petition Seeks Ban on Music in DTC Ads [316 Words] [ Price : $8.95]
A citizen petition asks FDA to ban music in direct-to-consumer television, radio and internet streamed advertisements because it distracts the audience’s attention from product side effects and contraindications.
08/03/2020
 
 
TXT Content/Process Guide for Pediatric Study Plans [195 Words] [ Price : $8.95]
FDA posts a final guidance on content and submission process for pediatric study plans.
08/03/2020
 
 
TXT Janssen sNDA for Spravato OK’d for Major Depression [244 Words] [ Price : $8.95]
FDA approves a Janssen Pharmaceutical supplemental NDA for Spravato (esketamine) nasal spray, taken with an oral antidepressant, to treat depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior.
08/03/2020
 
 
TXT Submission Data Elements for Imported Vet Devices [95 Words] [ Price : $8.95]
Federal Register proposed rule: FDA proposes to amend its regulations to require that certain data elements be submitted for veterinary devices that are being imported.
07/31/2020
 
 
TXT FDA Withdraws Watson Generic Oxycodone/Ibuprofen [81 Words] [ Price : $8.95]
Federal Register notice: FDA withdraws approval of a Watson Pharmaceutical ANDA for oxycodone hydrochloride and ibuprofen tablets, indicated for relieving pain.
07/31/2020
 
 
TXT Genentech Triple Combo OK’d for Melanoma [183 Words] [ Price : $8.95]
FDA approves a Genentech supplemental BLA for its triple combination of Tecentriq (atezolizumab) plus Cotellic (cobimetinib) and Zelboraf (vemurafenib) for treating BRAF V600 mutation-positive advanced melanoma patients.
07/31/2020
 
 
TXT FDA Adds 4 APIs to Compounding List [153 Words] [ Price : $8.95]
Federal Register notice: FDA identifies four drug substances to be added to its list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need for use in drug compounding.
07/31/2020
 
 
TXT BMS/Bluebird Resubmit BLA for Multiple Myeloma [212 Words] [ Price : $8.95]
Bristol Myers Squibb and Bluebird Bio re-file their BLA for idecabtagene vicleucel, indicated for treating patients with heavily pre-treated relapsed and refractory multiple myeloma.
07/31/2020
 
 
TXT Catalyst Loses NDA Lawsuit Against FDA [206 Words] [ Price : $8.95]
Catalyst Pharmaceuticals loses against FDA in a lawsuit over the agency's approval of competitor Jacobus Pharmaceutical’s Ruzurgi (amifampridine).
07/31/2020
 
 
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