Pacira Exparel For Nerve Block: FDA Argues Against Broad Label, And Approval For Any Regional Use May Be In Jeopardy

Charleston's Hydexor Faces Tough Committee Review; Opioid/Anti-Emetic Combo May Increase Abuse Risk, FDA Says; Best Case Is Limited Label

FDA's New Push On Biosimilars Will "Facilitate Claims Of Interchangeability": What It Means

Prevision Policy Clips | Another Dye Is Cast: FDA Discloses Rejection of Potential Abuse-Deterrent Opioid Formulation

Trump Pricing Plan, Take Two: White House Paper Hits Same Themes As 2017 Executive Order; Focus On Items That Can Be Done Without Congress

FDA Creates Single Web Contact Point For Non-Industry Meeting Requests On Drug Issues; Includes List of Direct Contacts For Specific Types of Meetings

Budget Deal 2018: Donut Hole Discount Dialed Down To 70%, Biosimilars Pass-Through Status Protected; Real Pain For Pharma, But At Least IPAB Is Gone

Prevision Policy Clips | Drug Pricing Proposals In White House FY19 Budget Request

A New Model For Drug Development: FDA Sees Chance To Use Modeling To Shortcut Early Development; Workshop Is "First Step" On "Long Journey"

Prevision Policy Clips | House Ways and Means Committee HHS FY 2019 Budget Proposal Hearing

Senate Budget Deal: Biopharma Gives On Donut Hole Discounts Again, Providing GOP A Drug Price Win; IPAB Killed In Return; Medicaid Line Extension Rebates Revisited

Opioid Legislation on the Horizon: Ways & Means Discusses Potential Changes to Medicare Reimbursement For Pain and Addiction Therapies

FDA Leadership Succession: “Grooming” Younger Talent, Ensuring Pay Equity Across Centers Are Priorities For Gottlieb

Senate Biosimilar Hearing: Humira, Enbrel Prices And Patents Criticized, Remicade Seen As Success Story; Prior Authorization Reform Is Surprising Theme

FDA Ready To Embrace New Statistical Approaches For Oncology Drugs; Will Payors And Patients Be Ready Too?

Prevision Policy Clips | Part D "Donut Hole" Discount for Biosimilars in House-Passed CR

Antimicrobial QIDP Designations Under GAIN Show 74 Novel Products In Development; FDA Tells Congress More Incentives Would Help

FDA To Step Up Efforts To Put MDs In Touch With 503B Compounders For Office Use Supply; Facilitator Role To Try To Quiet Unhappy GOP Constituency

Prevision Policy Clips | “United States of Care” Non-Partisan, Non-Profit From Ex-CMS Head Andy Slavitt

FDA’s Digital Precert Program Could Benefit From Guides To Developers To Help Them Self-Assess Before Applying To FDA

Prevision Policy Clips | Biosimilar Cost Impact In Rheumatoid Arthritis

Ex-Pfizer SVP Cavazzoni Tapped As CDER Deputy To Replace Moscicki; Potential Woodcock Successor Brings Tech Efficiency To Trial Design

CMS Proposes 7-Day Opioid Supply Limit In Part D, Anticipating FDA REMS Changes; Gabapentin To Be Monitored As "Potentiator"

Prevision Policy Clips | CMS Proposes Opioid Prescribing Limits for Medicare Part D Plans in 2019

Prevision Policy Clips | Vertex Selects Triple Combo CF Agents For Phase III