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Attorney and data scientist Bradley Thompson says FDA data support the value of a breakthrough device designation for de novo subm...[ Price : $8.95]
CDRH director Jeffrey Shuren describes Center efforts to help sterilization facilities to reduce ethylene oxide emissions into the...[ Price : $8.95]
FDA approves Allergan Aesthetics Juvderm Volux XC for improving jawline definition in adults over the age of 21 with moderate to s...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Electronic Submission of Expedited Safety Reports From IND-...[ Price : $8.95]
FDA approves Coherus Cimerli as an interchangeable generic version of Genentechs Lucentis for all five label indications.[ Price : $8.95]
A Grid news report uses Linkedin data to estimate how many former FDAers are now working in regulated companies and discusses the ...[ Price : $8.95]
Alnylam Pharmaceuticals plans to file an NDA submission late this year for patisiran, indicated for treating transthyretin-mediate...[ Price : $8.95]
Federal Register notice: FDA announces a 9/7 Peripheral and Central Nervous System Drugs Advisory Committee meeting that will revi...