Trump Surrogate Endorses FDA’s Approach To Surrogates: Amicus CEO Applauds Patient-Centric Culture Under Woodcock

Weekly Highlights: April 17-21

HHS Opioid Policy Under Price: Continuity Of Themes Includes Emphasis On Driving Down Prescribing Of Addictive Pain Meds

FDA Neurology Division Is Early Adopter In Externally-Led Patient-Feedback Meetings; New Model Ramping Up In 2017

SMA Remain High Priority At FDA Post-Spinraza; External Patient Meeting Highlights Good Climate For Pipeline Therapies

Precision Antibiotics: FDA Considers Paths for Single-Species Antimicrobials; Advisors Wary Of Relying On Animal Models

“Breakthrough” Versus Coverage: CMS Weighs First CAR-T, Jazz Cancer Drug For 2018 Add-On Payment Incentive

OTC Antacid/Analgesic Combos Are Not “Rational,” FDA Committee Says; OTC Monograph System May Need Overhaul

Opioid Training Mandates: FDA Broadens Dialogue With May Workshop; Kick-Off For Next Phase Of Opioid Response

FDA User Fee Draft Released: “FDARA” Starts As Clean As Can Be; Will It Get Messier From Here?

FDA Ends ESA REMS: Rollback Of Drug Safety Programs Continues, Teeing Up Themes For Gottlieb Tenure At FDA

Weekly Highlights: April 10-14

FDA Hiring Can Resume With Freeze Lifted: OMB Directive Requires Streamlining Plans – Opening For Outsourcing Ideas

FDA’s Oncology Center of Excellence Handling Clinical Reviews Of High-Priority Products: CAR-T BLAs Among Likely First

Sarcopenia PFDD Meeting Is Weak On Drug Treatments; Ex-FDA Review Manager Attacks Drug Development and PFDD Sessions

Weekly Highlights: April 3-7

Commissioner Gottlieb’s First Test: Re-Setting FDA Opioid Policy Yet Again; Nominee Says It Will Be Top Priority When Confirmed

Abuse Deterrent Formulations Live: FDA Advisory Committee Vote on RoxyBond Indicates ADFs Are Still Approvable

FDA Nominee Gottlieb: Confirmation Hearing Augurs Well For Rapid Confirmation, Preserving Pro-Innovation Climate

Novo Appears To Have Substantial Postmarket Issues To Resolve With FDA on Factor IX PEGylated Hemophilia B Product

Drug Pricing To Move “Outside the FDA Context,” Senate Dems Agree; Path Clear For Clean User Fee Reauthorization

CMS Solicits Ideas To Improve Part D: Quality Measures One Area Of Focus; Opening For Co-Pay Reform?

Senate Dem Pricing Menu: “Negotiation” Means VA Pricing, “Reasonable Price” Clause Reborn; Part D Rebates Biggest Threat

Inspirion RoxyBond Abuse-Deterrent IR Opioid: FDA Review Documents Are Very Clean; Opana Fallout May Be Hurdle

FDA Tracker: Inspirion ADF Oxycodone Is Another Barometer On Deterrence Technology; Sarcopenia Patient Session April 6