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.Zogenix’ #SeizureTherapy gets FDA Breakthrough Designation #PvPClips

New CBER-CDER Data Standards Strategy bit.ly/2BH7NOA

.Express Scripts Pharmacy Benefit Services #drugspending report released bit.ly/2d6qFYR

Product-Specific Bioequivalence ANDA Guidances bit.ly/2sjRTWu

.Gilead Sciences’ triple combo #HIV treatment Biktarvy gets FDA approval #PvPClips

.U.S. FDA's Office of Generic Drugs 2017 report bit.ly/2nWw2z0

This month’s #340BConf will feature the seasoned pro Michael McCaughan Michael McCaughan of Prevision Policy on what to expect in year two of the Trump era.

#CBER's Vaccines and Related Biological Products AdComm March 1

Hydexor Ad Comm briefing docs bit.ly/2suYm0G

Exparel Ad Comm briefing docs bit.ly/2nTEAHO

Regulatory classification of #pharmaceutical co-crystals guidance bit.ly/2HfOMCc

.Amgen 🧪🔬🧬’s Blincyto sBLA to Oncologic Drugs AdComm March 7

ICER Spark’s Luxturna #GeneTherapy report bit.ly/2EvlVbe

Pre-Request for Designation final guidance bit.ly/2C1NZ8X

Akcea’s Volanesoren AdComm May 10

#Migraine: Developing drugs for acute treatment bit.ly/2GgK32b

Draft Amyotrophic Lateral Sclerosis guidance bit.ly/2nZympN

Duchenne Muscular Dystrophy final guidance bit.ly/2ELAhIa

#Epilepsy: Partial onset seizures draft guidance bit.ly/2EyBx1K

Early #Alzheimer's Disease revised draft guidance bit.ly/2o96fnl