Part D Hits Milestone: Majority Of Rx Beneficiaries Are Enrolled In Medicare Advantage Plans, MedPAC Says; Policy To Streamline Plan Choices Appears To Be Working

Prevision Policy Clips | Prior Authorization Reform? HHS Seeking Comment On Electronic Standards

Patient Experience Data Is Growing Feature Of FDA Product Reviews And Labels; More Opportunity May Exist For Supportive Information

CBO Retail Drug Pricing Report Provides Ammunition For Both Sides In “Negotiation” Debate; Will It Matter For Legislative Outlook?

Lessons Learned From A Decade Of Patient-Focused Drug Development: Meeting Discussion May Expand To Fill Disease-Specific Knowledge Gaps

Prevision Policy Clips | Office Of Neuroscience Deputy Director Position Is “Vacant At This Time,” FDA Says

Complex Innovative Trial Design Case Studies Posted By FDA: Three Examples In Pilot Project Include Lilly (Pain), Amgen (Lupus) And Roche (Lymphoma)

Prevision Policy Clips | Teresa Buracchio Is Acting Director Of The Division Of Neurology I After Departure Of Eric Bastings

FDA “Cures” Hiring Authority Preferred By Centers But Process Is Time-Consuming, GAO Report Finds; Agency-Wide Strategic Workforce Plan Needed

Prevision Policy Clips | Gilead Withdraws Two Zydelig Accelerated Approvals; CLL Indication Will Remain On Market

“Rise In Alternative Paths To Market” Is Among FDA Toughest New Challenges, Woodcock Says

Disease-Progression Modeling: Neuroscience Indications See Most Activity As FDA Looks To Long-Term Goal Of Making Clinical Trials More Efficient

Prevision Policy Clips | Califf Nomination Clears Health Committee, But Looks Tight In Full Senate

CBER Restructures Ahead Of PDUFA VII Staff Infusion; New Office Of Regulatory Operations Is Biggest Change; OTAT Reorganized To Better Balance Workload And Staffing

Prevision Policy Clips | Project Significant (Statistics In Cancer Trials): FDA’s Oncology Center of Excellence

Prevision Policy Clips | Acting Commissioner Woodcock’s Swan Song In Congress: “Most People Are Going To Get COVID”

CMS Proposed Aduhelm Coverage Policy Overrules FDA: Beta Amyloid Antibodies Will Only Be Covered In RCTs Intended To Demonstrate Safety And Efficacy

Prevision Policy Clips | Aduhelm Price Cut Prompts HHS To Re-Evaluate Part B Premium Increase With Coverage Policy Imminent

RMAT Expedited Designation Showing Appeal To AAV Gene Therapy Development Projects: Grounding In Clinical Benefit And Range Of Post-Market Alternatives Appear Well-Suited

Prevision Policy Clips | OCE Takes Capability Of Sponsors To Complete Confirmatory Trials Into Accelerated Approval Decisions, FDA Chief Of Medical Oncology Julia Beaver

Part D Point-Of-Sale Pricing Rule Would Save Manufacturers Almost $15 Billion Over 10 Years; CMS Starts With Pharmacy Payments To Lower Beneficiary Costs, Not Rebates

Prevision Policy Clips | Part D “Pharmacy Rebate” Rule Would Save Manufacturers Almost $15 Billion

Prevision Policy Clips | Lilly's Tirzepatide Would Be Cost-Effective If Priced Between $5,500 and $5,700

FDA Advisory Committee Trends: Non-COVID Meetings Are Very Rare – And Very Negative – In 2021

Prevision Policy Clips | Omicron Halts FDA Domestic Inspections, Further Delays Foreign Inspections