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Drug Pricing “Shadow Mark-Up”: E&C Minority Amendment Includes New Formula For Manufacturer Discount In Part D, Sliding Scale For Spread In B
October 18, 2019
House Labor Committee Moves HR 3: Partisan Vote On Price Negotiation But Bipartisan Concern About Drug Prices
October 18, 2019
Prevision Policy Clips | Three Takeaways From Three HR3 House Events
October 18, 2019
House Republicans Seize On “Slower Cures” Argument Against HR 3: Exclusivity Reforms Are Better Option, GOP Witness Suggests
October 18, 2019
FDA Antimicrobial Drugs Committee Endorses Shionogi’s Cefiderocol For cUTI Despite Mortality Imbalance In Real-World Study; Panel Voices Concerns Over Broader Off-Label Use
October 17, 2019
Rx Price Negotiation Moving Rapidly Through House, Getting More Extreme As It Goes; Bipartisan Deal On Part D Reform Still Feasible
October 17, 2019
Prevision Policy Clips | CMS Administrator Verma Will Face First Democratic Oversight Hearing Oct. 23
October 17, 2019
FDA Leadership Feels Urgency To Challenge Critics On Perception Of “Lowered Bar” For New Drug Approvals
October 17, 2019
How to Do More With Labeling: Individualization Of Treatment, New Sources Of Evidence Pose Challenges For FDA’s Primary Communication Tool
October 16, 2019
Prevision Policy Clips | Price Negotiation Push In The House: Two Mark-Ups, One Hearing Set For Thursday
October 16, 2019
CBO “Price Negotiation” Score: $369 Billion Part D Hit To Industry Is Just The Beginning; Dangerous Theme Of How Much Innovation Is Worth Sacrificing
October 15, 2019
Real-World Trials May Qualify As “Adequate And Well-Controlled” – When Appropriate Controls Are In Place, FDA’s Stein Says At Duke Workshop
October 15, 2019
Prevision Policy Clips | HR3 Price “Negotiation” Provisions Would Save Nearly $350 Billion In Part D, CBO Says
October 15, 2019
Shionogi Cefiderocol: “Real World” Study Backfires, Making Complicated UTI Drug A More Complicated Review For FDA And Committee; Will LPAD Path Help?
October 11, 2019
FDA “Uni-Review” Roll-Out: Psychiatric Division Is Among “Early Adopters”; Collaboration Is Key Theme For New OND
October 11, 2019
FDA Office Of New Drugs Reorg Getting Warm Welcome From Division Directors, But Hiring Will Be Significant Pressure Point
October 11, 2019
White House War On Guidances Expands: FDA Is Not Main Target, But May Feel Some Collateral Damage
October 11, 2019
Prevision Policy Clips | House Price Negotiation Hearings Will Continue With Ways & Means Committee Oct. 17
October 11, 2019
Anti-Kickback Statute Remains Barrier To Rx Value-Based Agreements; New Rules Do Have Some Secondary Impacts
October 10, 2019
Prevision Policy Clips | FDA’s Role In “N of 1” Trials: Woodcock And Marks Editorial In New England Journal of Medicine
October 10, 2019
OCE Stands Alone: No Immediate Future For Integration Of FDA Medical Product Centers
October 9, 2019
Biopharma Congress Takeaways: FDA Reorg Appears Smooth, But Enough Is Enough
October 9, 2019
Prevision Policy Clips | HHS Anti-Kickback NPRMs Out; Future Rulemaking May Look At Safe Harbors For Pharma Value-Based Contracting
October 9, 2019
Novartis Remediation Plan For AveXis Shows Effort To Avoid Disruptive Integration In Quality Control Can Be Counterproductive
October 8, 2019
Prevision Policy Clips | FDA Draft Guidance On “Authorized” Imports Sent To OMB
October 8, 2019
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