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Helping Biosimilars Compete: FDA/FTC Statement Underscores Policy Goal – But Long Gestation Period Illustrates Bureaucratic Reality
February 3, 2020
ICER Framework Updates: Pilot Will Assess RWE For Accelerated Approval Drugs; Evidence Re-Evaluations After One Year for All Drugs
February 3, 2020
Prevision Policy Clips | Biosimilar Competition: FDA/FTC Workshop Announced, Along With Promotional Guidance
February 3, 2020
Diabetes Safety Standards Update Headlines CDER 2020 Guidance Agenda; Another Big Year Planned For Clinical/Medical Advice
January 31, 2020
Encouraging Expanded Access: FDA Disputes Arguments That Cost-Recovery Rules Are A Barrier
January 31, 2020
Prevision Policy Clips | CMS Proposes Changes To Co-Pay Coupons, Rebate Retention Policies In ACA
January 31, 2020
Advisory Committee Tracker: ODAC Is Back In February With Early Prostate Cancer Phototherapy – And Hard-To-Explain Lilly Lung Cancer Review
January 30, 2020
CMS Medicaid “Block Grant” Proposal Allows Formularies – But With Some “Protected” Classes
January 30, 2020
Prevision Policy Clips | Medicaid Overhaul Proposal Will Permit States To Use Restrictive Formularies
January 30, 2020
Risks Of Re-Opening Orphan Drug Act: Rep. Schrader Suggests Removing Cost Recovery Option During House Hearing On Technical Fix
January 29, 2020
ICER Migraine Cost-Effectiveness Review Uses Alternative Timepoint For Maximum Benefit; Allergan Collaboration Pays Off – And Brings Call For FDA Participation Going Forward
January 29, 2020
CAR-T Patient Travel Reimbursement Okayed By HHS Inspector General; Twist On Patient Support Program Reflects Unique Care Delivery Model
January 29, 2020
Part D-For-All? Medicare Drug Benefit Could Be A Point Of Departure If Political Dynamics Shift Toward Medicare For All
January 29, 2020
Prevision Policy Clips | FDA Gene Therapy Guidance Suite
January 29, 2020
Hemophilia Gene Therapy Guidance Updates Endpoint Discussion But Not Conclusion: FDA Sees Accelerated Approval Based On Factor Activity, ABR As Confirmatory Endpoint
January 28, 2020
Gene Therapy Guidance “Suite” Finalized In 18 Months; Rapid Turnaround For FDA Also Underscores Limits Of Guidance Pathway For Fast-Moving Science
January 28, 2020
FDA Gene Therapy “Sameness” Policy Leans Toward Finding Differences, Enabling Competition Under Orphan Drug Act
January 28, 2020
Prevision Policy Clips | FDA Finalizes “Suite” Of Gene Therapy Guidances; Issues Draft On “Sameness” For Orphan Drug Purposes
January 28, 2020
FDA Commissioner Hahn’s Inner Circle Takes Shape: Incoming Deputy Anand Shah Seen As Potential Successor To Abernethy – And Future Commissioner?
January 28, 2020
Prevision Policy Clips | House FDA Hearing January 29 Features J&J Exec, Friends of Cancer Research CEO
January 27, 2020
Antibiotic Subscription Model: Duke-Margolis Proposal Blends Government Value Assessments With Private Purchasing/Distribution Entities
January 24, 2020
Prevision Policy Clips | Minimal Residual Disease Biomarker Use Final Guidance
January 24, 2020
Prevision Policy Clips | ODAC Gets Two Reviews In February: Steba Biotech’s Padeliporfin for “Low-Risk” Prostate Cancer, Lilly’s Cyramza For NSCLC
January 23, 2020
CDER Drug Risk Management Board Will Integrate Quality With Clinical Safety Leaders; First Public Output Of Drug Safety Overhaul Under Deputy Cavazzoni
January 22, 2020
Golodirsen Approval Package Includes Commitment By Sarepta To Withdraw Vyondys 53 If Confirmatory Trial Does Not Show “Sufficient” Evidence Of Benefit
January 22, 2020
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