CMS’ Slavitt Urges “Collaborative” Approach To Rx Pricing Solutions; Good Cop Now Or Bad Cop Later?

MedPAC Drug Pricing Discussion: For Now, Policy Focus Stays On Tweaking Parts B & D; Broader Ideas Deferred Until 2016

Merck Receives Validation For Sugammadex With Second Unanimous Advisory Committee Vote

FDA Committees Give FDA Strong Support To Relabel Fluoroquinolones; Latitude On Disability Syndrome

Generic Review Goal Simplification Proposed By FDA For GDUFA Reauthorization; “Priority” Reviews May Be Political Winner

CMS Invites Hep C Companies To Discuss “Ideas” For Outcomes-Based Pricing; Orders States To Drop Restrictive Coverage

Merck’s Sugammadex: Is Fourth Time A Charm? FDA Review Documents Set Up Tough Challenge; Anaphylaxis Risk Is Key

Senate Bill Would Authorize Medicare Lock-Ins For Opioid Prescribing/Dispensing; Separate Bill Could Slow “Cures” Effort

FDA Commissioner Nominee Califf Hears Industry Ideas For R&D “Renaissance,” Says Patient-Centered Development Is Key

Senate Aging Committee Launches Bipartisan Drug Pricing Investigation; Legislative Focus On Generic Competition, FDA

Obesity Drug Coverage: CBO Analysis Points To Disconnect Between Categories In Rx Labels And Economic Impact

Obama Administration Drug Pricing Forum Set For Nov. 20: HHS/CMS High Drug Cost Working Group Ideas Likely to Be Debuted

FDA Finalizes HIV Development Guidance: Minimal Refinements Reinforce Themes From Patient Feedback

Biosimilar Part B Pricing: CMS Persists With Single-Code, Blended Rate In 2016 Payment Rule; Impact In Future, Not Now

Senate HELP Committee Takes Interest in the BRAIN During Mental Health Hearing

Animal Rule Guidance: Drug Development for Rare or Extreme Cases Where Efficacy Trials In Humans Are Not Doable

FDA Advisory Committee Tracker: D-Day For DMD Drug During Thanksgiving Week; “Low-T” Review Scrapped

FDA to Consider Making Domperidone Expanded Access Easier; Compounding Adcomm Continues to Review Bulk Substances

ICER Panel on PCSK9s is "Inconclusive" on Value of Drugs; Physician Society Guidelines Likely To Be A Focus For CEPAC

FDA May Start Seeing Orphan Drug Designation Requests That Rely On Non-Profitability Criterion, Not Patient Population

Senate Innovation Bill May Include Expedited ANDA Language; GDUFA Oversight Will Follow, Putting FDA In Hot Seat

Budget Deal Includes Sanders/Cummings Proposal To Limit Generic Price Increases; Broader Impact On Generic Supply?

FDA Issues Interim Compounding Policy to Allow Use of Certain Bulk Substances While Formal Evaluation Continues

Patient-Focused Drug Development Next Steps: Developing Guidance on How to Collect Evidence– After PDUFA VI

Arthritis Advisory Committee “Conflicted” Over Approval Recommendation for AstraZeneca’s Gout Drug Lesinurad