Niemann Pick COA Measure Needs “Bolstering” But Still Holds Deep Value In Type C Research, NPC Community Tells FDA/Duke Endpoint Meeting

FDA/White House Interactions May Improve With CDER Deputy Sipes Joining Office Of Science & Technology; Jungman To Be Policy Lead In CDER

Prevision Policy Clips | Biogen/Eisai Give Details On Aduhelm Confirmatory Study: Racial Diversity Is Key Goal

Senate COVID Response Bill Includes FDA Reforms: “Platform” Approvals Revived, Directives On RWE, Foreign Inspections, De-Centralized Trials Are Part Of “Discussion Draft”

Prevision Policy Clips | Senate Pandemic Response Bill Includes Directives For FDA On Decentralized Trials, Foreign Inspections And RWE

CBER Plans To Finalize Neurodegenerative Gene Therapy Guidance In 2022, Developing “Voluntary Consensus Standards Recognition Program” For Regenerative Medicine

Prevision Policy Clips | EUA Pathway Not Appropriate For Rare Diseases, CBER’s Marks Says In Response To Critics

Prevision Policy Clips | Yo-Yo Approval? Oncopeptides Ready To Challenge FDA On “Dangling” Accelerated Approval Stance

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