Prevision Policy Clips | Product-Specific Guidances Released

PBPK Final Guidance: Simulations For Dosing Need To Be “Discussed and Justified”

Prevision Policy Clips | Amended Gag Clause Bill to E&C Markup

Louisiana Purchase: State Rx Subscription Payment Model Will Require Federal Approval

HHS Deputy Secretary Hargan To Give Drug Pricing Priorities Keynote At Biopharma Congress

Prevision Policy Clips | Celltrion/Teva’s Rituximab Biosimilar Goes To Advisory Committee Oct. 10

Oncology R&D Requires “Outside The Box” Thinking For Preclinical Safety: New Modalities Should Not Follow Cytotoxic Model, FDA Official Says

Pfizer Bacterial Toxin Vaccines Highlighted At Research!America Forum; R&D Head Cites Close Work With FDA’s CBER

FDA Chief Counsel Cline Amin Cements Ties To Key Congressional Committees

Prevision Policy Clips | Zelnorm Reborn? US WorldMeds Application To Relaunch IBS Therapy Goes To FDA Advisory Committee

Essential Drug List For Shortages On Agenda For FDA Nov. 27 Public Hearing; ASPR Looking Ahead To New Distributed Manufacturing Solutions

Loose Lips? Pharmacy “Gag Clause” Bill Advances In House – Along With Bill To Allow CMS To Share Rebate Data With MedPAC

Prevision Policy Clips | Senate Set To Pass Opioid Response Bill Next Week

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