Prevision Policy Clips | Combo Products With Electronic/Software “Platform” Drug Master File Guidance Issued October 28

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?

Prevision Policy Clips | OTC Monograph Reform Resurfaces: Senate HELP Markup Scheduled

Mandatory Post-Marketing Studies: FDA Affirms Wide Scope Of New Authority To Order Trials For “Reduced Effectiveness” In Updated Draft Guidance

CMS Administrator Faces Critics In House Oversight Hearings; Republicans Use Event To Seek Ideas On Value-Based Payment Options

Prevision Policy Clips | International Drug Manufacturing Will Be Focus Of House Supply Chain Hearing October 30

HR3 Heads To House Floor: Upcoming Vote Could Allow Return To Bipartisan Part D Talks; Time For Biopharma To Rebuild Innovation Defense

Prevision Policy Clips | HR3 On Track For House Floor Vote Oct. 28; Marathon Mark-Up Leads To Predictable Result

White House On HR3: Only “Red Line” Is No New Money For ACA

Prevision Policy Clips | A Big Test For FDA: Biogen Plans To Submit Aducanumab For Alzheimer’s After All

FDA Expands “Cures” Hiring Authority To Fill Range Of Open Positions; 80 Appointments Made To Date

Prevision Policy Clips | Ways & Means HR 3 Markup October 22

Drug Pricing “Shadow Mark-Up”: E&C Minority Amendment Includes New Formula For Manufacturer Discount In Part D, Sliding Scale For Spread In B

House Labor Committee Moves HR 3: Partisan Vote On Price Negotiation But Bipartisan Concern About Drug Prices

Prevision Policy Clips | Three Takeaways From Three HR3 House Events

House Republicans Seize On “Slower Cures” Argument Against HR 3: Exclusivity Reforms Are Better Option, GOP Witness Suggests

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

Rx Price Negotiation Moving Rapidly Through House, Getting More Extreme As It Goes; Bipartisan Deal On Part D Reform Still Feasible

Prevision Policy Clips | CMS Administrator Verma Will Face First Democratic Oversight Hearing Oct. 23

FDA Leadership Feels Urgency To Challenge Critics On Perception Of “Lowered Bar” For New Drug Approvals

How to Do More With Labeling: Individualization Of Treatment, New Sources Of Evidence Pose Challenges For FDA’s Primary Communication Tool

Prevision Policy Clips | Price Negotiation Push In The House: Two Mark-Ups, One Hearing Set For Thursday

CBO “Price Negotiation” Score: $369 Billion Part D Hit To Industry Is Just The Beginning; Dangerous Theme Of How Much Innovation Is Worth Sacrificing

Real-World Trials May Qualify As “Adequate And Well-Controlled” – When Appropriate Controls Are In Place, FDA’s Stein Says At Duke Workshop

Prevision Policy Clips | HR3 Price “Negotiation” Provisions Would Save Nearly $350 Billion In Part D, CBO Says