Prevision Policy Clips | Hospital-Owned Generic Drug Non-Profit Manufacturer To Be Led By Former Amgen QC Exec Martin Van Trieste

Pharmacy “Gag Clause” Bill May Need Revisions For Patient Safety; As With Most Drug Pricing Issues, Simple Fix Isn’t So Simple

FDA Biosimilars Hearing Tees Up Legal Debates That Will Define Exclusivity– But Not For Years To Come; Mylan Says “Umbrella Exclusivity” Is “Ruled Out” By Law

Prevision Policy Clips | Peter Bach Appointed MEDCAC Chair

Advisory Committee Tracker: Summer Lull Carries Over Into September

Biopharma Congress IV

Prevision Policy Clips | NCPA Will Testify In Support Of Bill To End “Gag Clauses”

Prevision Policy Clips | Gag Clause Discussion Draft Among Five Bills at E&C Hearing Wednesday

CMS Takes Another Step To Give Part D Plans More Leverage In Price Negotiations: “Indication-Based Formulary Design” Allowed For 2020

Prevision Policy Clips | Bayer Hemophilia A Treatment Jivi Approved

Anti-Kickback “Safe Harbor” Request For Information Issued By HHS OIG; Will It Delay Release Of The Drug Rebate Rule?

“Complex Innovative Designs” Pilot Program Begins At FDA; Public Disclosure Will Be Key Issue For Companies Who Volunteer

FDA Overhauling Pain Drug Development Guidance: “Opioid Sparing” Guidance Coming Soon; FDA Notes Opioid Rx Levels Have Fallen To 2004 Levels

Prevision Policy Clips | RMAT Update: One-Third Granted

Prevision Policy Clips | Tetraphase’s Intra-Abdominal Infection Antibiotic Approved

“Non-Traditional” Antibacterials: FDA, Industry See Novel Goals – Not Mechanisms – As Key Regulatory Challenge

Prevision Policy Clips | Monday, August 27, 2018

Prevision Policy Clips | Friday, August 24, 2018

Prevision Policy Clips | Placebo-Controlled Cancer Trials: FDA Wants To Make Sure Unblinding Occurs

CMS MEDCAC On CAR-Ts: Patient-Reported Outcomes Make The Jump To Medicare Coverage Decisions

What If Trump Leaves? HHS May Be Point Of Stability In Chaos

FDA Osteoarthritis Draft Guidance: Starting Over On Structural Claims

Prevision Policy Clips | Senate Opioid Bill to Floor After Labor Day

Prevision Policy Clips | Request for Info on Anti-Kickback Penalties Coming Soon

HHS “100-Day Report” On Drug Pricing Touts Manufacturer Price Restraint, Previews Pending Rebate “Safe Harbor” Rule