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Infected Trials: FDA Allows Flexibility In Clinical Trial Assessments From COVID-19, Ultimately Setting Different Review Expectations
March 18, 2020
Prevision Policy Clips | President Trump To Announce FDA Developments On COVID-19
March 18, 2020
OND Re-Org Enters Final Phase: New Faces In FDA Division Director Line Up Include Donohue (Rare Disease), Toerner (Hepatology), And Nikolov (Rheumatology)
March 17, 2020
Prevision Policy Clips | OND Re-org: Final Phase Begins March 15
March 17, 2020
Part D Redesign: CBO Sees Net Increase In Spending On Drug Benefit In Updated Senate Bill, Driven By Price Concession Pass Through; Inflation Penalty Still Drives Savings Overall
March 16, 2020
Prevision Policy Clips | FDA Drug Center Doing "Everything Possible" To Keep Reviews On Schedule, But Acknowledges Uncertainty
March 16, 2020
CMS Says Reduced Or No Cost-Sharing In Emergency COVID-19 Response Would “Satisfy” Anti-Kickback Safe Harbor
March 13, 2020
Prevision Policy Clips | "Competitive Generic Therapies" Do Not Automatically Get Expedited Review, Final FDA Guidance
March 13, 2020
COVID-19 Impact On Drug Reviews: Thinking Through Scenarios
March 12, 2020
Prevision Policy Clips | Trump Executive Order Promoting Government Purchasing Of American-Made Pharmaceuticals, Medical Equipment
March 12, 2020
Possible Drug Review Delays Get Zero Attention At House Appropriations Hearing; FDA’s Hahn Faces Another Credibility Test
March 11, 2020
Continuous Manufacturing Bill Passes Energy & Commerce Health Subcommittee With Coronavirus Top Of Mind
March 11, 2020
Insulin Manufacturers Have One Week To Opt-In To Part D Fixed-Copay Demo; CMS Wants $35 Per Month Cap, Sees Potential $250 Million In Savings
March 11, 2020
MedPAC Wants To Tamp Down Separately Payable Drugs In Hospital Outpatient Setting: NTAP-Style Clinical Improvement Standard May Be One Outcome
March 11, 2020
Prevision Policy Clips | White House Forwards Drug Pricing "Principles" To Congress, If Anyone Is Paying Attention
March 11, 2020
CDER Meetings Cancelled Through April, Woodcock Says; Foreign Inspections Postponed
March 10, 2020
Biosimilar Competition: FDA/FTC Workshop Highlights Glass Half-Full Picture Of Market; “Level Playing Field” Arguments Reflect Brand v. Brand Dynamic
March 10, 2020
Prevision Policy Clips | FDA Postpones Nonprescription Drugs Advisory Committee, Gene Therapy Conference, Vitiligo Patient Meeting
March 10, 2020
Diabetes Safety Guidance Goes Beyond CV Risk To Consider Broader Outcomes; FDA Drops “Goalpost” Approach
March 9, 2020
Prevision Policy Clips | FDA Announces “Updated Approach” To Diabetes Safety; No More "Goalpost" Approach
March 9, 2020
Rx Addiction Training Standards: House Weighs Bills To Ease Rules For Treatment, Mandate Training For Pain/Stimulant Scripts; Neither Likely To Move Quickly
March 6, 2020
Prevision Policy Clips | FDA Panel Meetings In April, May Are Still On Despite COVID-19 Concerns
March 6, 2020
Ultra-Rare Gene Therapy: Industry Support For Non-Commercial Model May Help Build “Goodwill,” FDA’s Marks Suggests
March 6, 2020
MedPAC Part D Overhaul Plan Set For Vote In April: Rx Discount Likely To Be Set Above 20%; Another Tweak May Allow Rebate-Free Plans Sooner
March 5, 2020
FDA Draft Guidance Encourages Flexible Designs To Enroll “Older Adults” In Cancer Trials, With Special Focus On The Over-75 Population
March 5, 2020
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