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Agile’s Twirla Heads To Committee: Third Strike Likely For Patch Contraceptive; FDA Sees “Unacceptable” Efficacy Shortfall
October 28, 2019
Prevision Policy Clips | Combo Products With Electronic/Software “Platform” Drug Master File Guidance Issued October 28
October 28, 2019
Makena Status In Doubt On Two Fronts: Failure To Confirm Clinical Benefit And Lack Of Evidence For Surrogate, FDA Says; Enough To Pull Standard Of Care?
October 25, 2019
Prevision Policy Clips | OTC Monograph Reform Resurfaces: Senate HELP Markup Scheduled
October 25, 2019
Mandatory Post-Marketing Studies: FDA Affirms Wide Scope Of New Authority To Order Trials For “Reduced Effectiveness” In Updated Draft Guidance
October 24, 2019
CMS Administrator Faces Critics In House Oversight Hearings; Republicans Use Event To Seek Ideas On Value-Based Payment Options
October 24, 2019
Prevision Policy Clips | International Drug Manufacturing Will Be Focus Of House Supply Chain Hearing October 30
October 24, 2019
HR3 Heads To House Floor: Upcoming Vote Could Allow Return To Bipartisan Part D Talks; Time For Biopharma To Rebuild Innovation Defense
October 23, 2019
Prevision Policy Clips | HR3 On Track For House Floor Vote Oct. 28; Marathon Mark-Up Leads To Predictable Result
October 23, 2019
White House On HR3: Only “Red Line” Is No New Money For ACA
October 22, 2019
Prevision Policy Clips | A Big Test For FDA: Biogen Plans To Submit Aducanumab For Alzheimer’s After All
October 22, 2019
FDA Expands “Cures” Hiring Authority To Fill Range Of Open Positions; 80 Appointments Made To Date
October 21, 2019
Prevision Policy Clips | Ways & Means HR 3 Markup October 22
October 21, 2019
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
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