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Federal Register notice: FDA releases a final guidance describing insanitary conditions at drug compounding facilities.[ Price : $8.95]
FDA posts a final guidance on Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017.[ Price : $8.95]
FDA implements a certification program for medical devices not exported from the U.S.[ Price : $8.95]
FDA releases a final guidance on Insanitary Conditions at Compounding Facilities.[ Price : $8.95]
Senhwa Biosciences says its clinical partner, Center for Advanced Research and Education, has received a study-may-proceed letter ...[ Price : $8.95]
Attorneys from Hogan Lovells opine that the Covid-19 emergency has had the unintended consequence of cementing the use of real-wor...[ Price : $8.95]
FDA approves a Sedor Pharmaceuticals NDA for Sesquient (fosphenytoin sodium for injection) for treating status epilepticus in adul...[ Price : $8.95]
FDA extends its review of a Lipocine NDA resubmission for Tlando, an oral testosterone product candidate for hormone replacement t...