CSI-FDA? “Controlled Substances Initiatives” Team Will Launch Opioid Data Warehouse in March; Agency Developing Cocaine/Methamphetamine Use Disorder Guidance

Prevision Policy Clips | CMS Plans To Streamline Prior Authorization Process

Prevision Policy Clips | HDA Names Chip Davis New CEO; AAM Starts Search Amid “Wholesale” Changes To DC Association Leadership

Flu Vaccine Upgrade Would Be Supported By Enhanced Medicare Payments Under Trump HHS Proposal

HHS 2021 Budget Request Drops Specifics On Drug Pricing In Favor Of General Call For Legislation; FDA Does Well Once Again Relative To Other Agencies

Prevision Policy Clips | HHS Secretary Azar To Testify On President's Budget Thursday

MPS III Rare Disease Guidance From FDA Explicitly Seeks Patient-Caregiver Preferences In Endpoints; “Large Treatment Effect” Could Obviate Randomization

Prevision Policy Clips | Federal Register Unavailable Feb. 7

Part D “Specialty” Tier Overhaul: “Preferred-Specialty” Will Test Plans’ Ability To Get Rebates; Threshold Jumps To $780 Per Month

Barrier Riffs: House Pharmaceutical “Barriers” Hearing Focuses On Patient Assistance Programs, Overseas Tax Loopholes

FDA Biosimilar “Carve Out” Draft Guidance Reflects Established Precedents; Agency Promises Six-Month Reviews For 351(k) Supplements To Add Indications

FDA “Quality Maturity” Rating: Stakeholders Welcome Transparency But Raise Issues About International Inspection Disparity, Need For Product-Level Data

Prevision Policy Clips | Thursday, February 6, 2020

FDA Oncology “Project 2025” Initiative Will Kick Off With Disease Area Workshops This Year; OCE Showcases Ongoing Projects At Anniversary Event

Prevision Policy Clips | Trump Calls Out Grassley Drug Pricing Bill, No Mention Of International Reference Pricing

FDA Under Stephen Hahn: Commissioner Likely To Focus On Agency Operations, Not New Policy

Prevision Policy Clips | FDA Electronic Submissions and Data Standards Public Meeting

Helping Biosimilars Compete: FDA/FTC Statement Underscores Policy Goal – But Long Gestation Period Illustrates Bureaucratic Reality

ICER Framework Updates: Pilot Will Assess RWE For Accelerated Approval Drugs; Evidence Re-Evaluations After One Year for All Drugs

Prevision Policy Clips | Biosimilar Competition: FDA/FTC Workshop Announced, Along With Promotional Guidance

Diabetes Safety Standards Update Headlines CDER 2020 Guidance Agenda; Another Big Year Planned For Clinical/Medical Advice

Encouraging Expanded Access: FDA Disputes Arguments That Cost-Recovery Rules Are A Barrier

Prevision Policy Clips | CMS Proposes Changes To Co-Pay Coupons, Rebate Retention Policies In ACA

Advisory Committee Tracker: ODAC Is Back In February With Early Prostate Cancer Phototherapy – And Hard-To-Explain Lilly Lung Cancer Review

CMS Medicaid “Block Grant” Proposal Allows Formularies – But With Some “Protected” Classes

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