Request Processed

Your registration request has been processed. We will contact you soon.

Register

PrevisionPolicy logo
  • Login
  • Register
  • About
  • Contact Us
1 2 3 4 5 6 Next › Last »

FDA’s OTC Paradigm Cannot Begin Until “ACNU” Rule Is Final; “Additional Condition For Nonprescription Use” Is Not “Third Class” In Disguise

February 7, 2023

Prevision Policy Clips | Senate Judiciary Committee Will Mark Up Pharma Bills

February 7, 2023

CMS And Accelerated Approval: Pricing Demos Under Discussion But “There Is No Simple Answer”; Aduhelm Policy Is “Unique Circumstance,” Agency Tells NASEM Workshop

February 6, 2023

Prevision Policy Clips | CBER Deputy Celia Witten Will Lead Office Of Therapeutic Products

February 6, 2023

Part D Out Of Pocket Cap Set At $8,000 For 2024 Before Benefit Re-Design Kicks In For 2025; Insulin, Adult Vaccine Co-Pays Spelled Out By CMS

February 3, 2023

The Competing Legacies Of Aduhelm: FDA Feels Vindicated, But Expanding Role Of Accelerated Approval Depends On Heeding Calls For More “Transparency”

February 3, 2023

Prevision Policy Clips | Senate Finance Chair Wyden Urges CMS To Move Quickly On Medicare Rx Inflation Rebate Invoices

February 3, 2023

Prevision Policy Clips | House Hearing Suggests Bipartisan Interest In Banning “QALYs” In Federal Payment Policy

February 2, 2023

Accelerated Approval Changes In FDORA Play Well At NASEM Workshop; FDA Planning Multiple Guidances, Says “Authority” In Statute Will Help With Confirmatory Trials

February 1, 2023

FDA External Controls Guidance: Controlling Time Issues Is Key To Use In Studies For Regulatory Submission; Next Chapter In FDA’s RWE Draft Guidance Portfolio

February 1, 2023

FDA Office Of Regulatory Affairs Role Will Change As Part Of Broader Restructuring Focused On Food Safety; Details TBD

February 1, 2023

Prevision Policy Clips | FDA's Califf Faces First GOP Oversight Hearing

February 1, 2023

Advisory Committee Tracker: FDA Has Busy Start To 2023; Agenda Includes ALS Drug, Two RSV Vaccines, Another Unusual ODAC And Opioid Response Topics

January 31, 2023

CBER Gene Therapy "Super Office" Transition Includes New Leadership: OTAT Director Wilson Bryan To Step Down In Coming Weeks

January 31, 2023

Prevision Policy Clips | CBER Gene Therapy Review Office Will Have New Director; Wilson Bryan Is Retiring In March

January 31, 2023

Prevision Policy Clips | Biopharma Congress Is Two Weeks Away On Feb. 13: CBER Director Peter Marks

January 30, 2023

TGT’s MS Agent Briumvi May Have Some Convenience Advantage Over Genentech’s Ocrevus, ICER Panel Says, But Low Value Versus Generic Tecfidera

January 27, 2023

FDA Wants More COVID-19 Manufacturers At The Table: “Simplified” Vaccine Campaign Will Help, CBER’s Marks Says

January 27, 2023

Prevision Policy Clips | Second Naloxone OTC Application Heads To Advisory Committee March 20

January 27, 2023

FDA Punts To Congress On CBD Regulation: “New Pathway” Debate Will Reinforce Likelihood That Broader Drug Regulatory Topics Stay Out Of Political Spotlight

January 26, 2023

Cidara/Melinta’s Rezafungin On Track To Be First “Limited Use” Antifungal After Positive Committee Vote; Once-Weekly Dosing Viewed As Clear Clinical Advantage

January 26, 2023

Prevision Policy Clips | House Democrats Establish Committee Membership with New Jersey’s Frank Pallone

January 26, 2023

Prevision Policy Clips | Another AA Review By ODAC: Genentech Polivy Will Be Reviewed March 9 For First Line Indication

January 25, 2023

Prevision Policy Clips | Makena Gets Closer To Forced Withdrawal: Presiding Officer Celia Witten Agrees With CDER, Hearing Outcome

January 24, 2023

COVID Vaccines Moving To Flu Model: FDA Advisory Committee Will Be Asked To Ratify “Simplified” Annual Strain Selection Process

January 23, 2023
1 2 3 4 5 6 Next › Last »

Patient-Focused
Drug Development
Database

Access database reports on PFDD meetings.

Log In
LEARN MORE
PrevisionPolicy logo sailboat

What is Prevision Policy?

Prevision Policy provides breaking analysis for biopharma on drug regulation, policy and market access. Our continuous information service gives decision makers actionable insight when they need it most on FDA, CMS, Congress, and how developments in policy impact commercial success.

Prevision Policy was started with the belief that information must be trustworthy, interactive, fast as it is deep, and deliver the bottom line. Strategy is developed in real-time and the biopharma business landscape can change quickly and without warning. Our service has been developed to address those challenges and turn them into opportunities.

To request more information about a company license to the Prevision Policy continuous information service or to get further details about the services we offer, please click here.

Biopharma Congress

Tweets by PrevisionPolicy

Copyright © 2023 Prevision Policy. All Rights Reserved. Privacy Policy