FDA Awaiting Guidance On Guidances From HHS: How Trump Regulation Trimming Will Affect Lesser Tools Is Still Unclear

Weekly Highlights: March 27-31

ICER Rheumatoid Arthritis Review Highlights First-Mover, Multi-Indication Advantages: A Multi-Drug Specialty Category

Rituximab SubQ: ODAC Cites “Compelling” Bridging Study Data, Safety Profile In Unanimous Approval Vote

FDA Inspection Delays Remain Sticking Point For First-Cycle Approvals; CDER Says Quality Office Will Bring Improvements

PDUFA At 25 Years: FDA Review Efficiency Has Peaked; Focus Shifting To Ways To Improve Earlier Stages of Development

FDA and NIH Alter Story On Opioid Tech Solution: Moving From Abuse Deterrence to Prevention, Non-Opioid Pain Options

Genentech’s Subcutaneous Rituximab/Hylauronidase Deemed “Comparable” to IV Formulation by FDA; No Major Safety Concerns

Weekly Highlights: March 20-24

Trump Administration Declines Support For PDUFA VI: FDA Responds With History Lesson On Negative Impact of Threats

Restricted Distribution Reform—Beyond REMS—Has Bipartisan Support; Celgene Cited Alongside Daraprim At House Hearing

FDA’s Oncology Center Of Excellence Takes Shape: Elevated Status Within Agency, Additional “Moonshot” Hires Coming

FDA’s Efficacy Standard Under Attack: Commissioner Gottlieb Defuses Threat, But Drug Approval Criteria Could Still Shift

REMS Reform In User Fee Reauthorization Could Lower Drug Prices; Speeding ANDA Reviews Not Total Solution, FDA Says

PBPK Modeling Tool For NDAs May Help Speed ANDA Reviews; Advisory Cmte Showcases FDA Work On Modeling/Simulation

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

Weekly Highlights: March 13-17

The Advisory Committee Drought Is Ending: ODAC To Review Array MEK Inhibitor, Genentech Rituxan SubQ On March 29

100% User Fees For FDA? Premarket Review Would Rely Solely On Industry Fees in Trump Budget; Deep Cuts to NIH Proposed

Wyden PBM Transparency Bill Includes Lower Co-Pays But Gets Closer To Open Net Price: Pharma Claps or Pharma Trap?

PDUFA Point People: FDA Deputy Abram Should Help Assure Smooth User Fee Cycle; HHS Staff Appointments Help Too

Abuse Deterrent Failure: Advisory Committee Says Opana ER Backfired; Another Challenge For Opioid Policy At FDA

FDA “Patient Affairs” Office Floated: Would Integrate Patient Input Activities Across Centers

FDA Commissioner Nominee Scott Gottlieb: “Establishment” Pick Wins Over Pure Silicon Valley Choices

Accelerated Generic Drug Reviews By FDA (HR 749) Has Full Attention of House Health Subcmte; GDUFA Add-On Likely