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CSI-FDA? “Controlled Substances Initiatives” Team Will Launch Opioid Data Warehouse in March; Agency Developing Cocaine/Methamphetamine Use Disorder Guidance
February 12, 2020
Prevision Policy Clips | CMS Plans To Streamline Prior Authorization Process
February 12, 2020
Prevision Policy Clips | HDA Names Chip Davis New CEO; AAM Starts Search Amid “Wholesale” Changes To DC Association Leadership
February 11, 2020
Flu Vaccine Upgrade Would Be Supported By Enhanced Medicare Payments Under Trump HHS Proposal
February 11, 2020
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
February 10, 2020
Prevision Policy Clips | HHS Secretary Azar To Testify On President's Budget Thursday
February 10, 2020
MPS III Rare Disease Guidance From FDA Explicitly Seeks Patient-Caregiver Preferences In Endpoints; “Large Treatment Effect” Could Obviate Randomization
February 7, 2020
Prevision Policy Clips | Federal Register Unavailable Feb. 7
February 7, 2020
Part D “Specialty” Tier Overhaul: “Preferred-Specialty” Will Test Plans’ Ability To Get Rebates; Threshold Jumps To $780 Per Month
February 6, 2020
Barrier Riffs: House Pharmaceutical “Barriers” Hearing Focuses On Patient Assistance Programs, Overseas Tax Loopholes
February 6, 2020
FDA Biosimilar “Carve Out” Draft Guidance Reflects Established Precedents; Agency Promises Six-Month Reviews For 351(k) Supplements To Add Indications
February 6, 2020
FDA “Quality Maturity” Rating: Stakeholders Welcome Transparency But Raise Issues About International Inspection Disparity, Need For Product-Level Data
February 6, 2020
Prevision Policy Clips | Thursday, February 6, 2020
February 6, 2020
FDA Oncology “Project 2025” Initiative Will Kick Off With Disease Area Workshops This Year; OCE Showcases Ongoing Projects At Anniversary Event
February 5, 2020
Prevision Policy Clips | Trump Calls Out Grassley Drug Pricing Bill, No Mention Of International Reference Pricing
February 5, 2020
FDA Under Stephen Hahn: Commissioner Likely To Focus On Agency Operations, Not New Policy
February 4, 2020
Prevision Policy Clips | FDA Electronic Submissions and Data Standards Public Meeting
February 4, 2020
Helping Biosimilars Compete: FDA/FTC Statement Underscores Policy Goal – But Long Gestation Period Illustrates Bureaucratic Reality
February 3, 2020
ICER Framework Updates: Pilot Will Assess RWE For Accelerated Approval Drugs; Evidence Re-Evaluations After One Year for All Drugs
February 3, 2020
Prevision Policy Clips | Biosimilar Competition: FDA/FTC Workshop Announced, Along With Promotional Guidance
February 3, 2020
Diabetes Safety Standards Update Headlines CDER 2020 Guidance Agenda; Another Big Year Planned For Clinical/Medical Advice
January 31, 2020
Encouraging Expanded Access: FDA Disputes Arguments That Cost-Recovery Rules Are A Barrier
January 31, 2020
Prevision Policy Clips | CMS Proposes Changes To Co-Pay Coupons, Rebate Retention Policies In ACA
January 31, 2020
Advisory Committee Tracker: ODAC Is Back In February With Early Prostate Cancer Phototherapy – And Hard-To-Explain Lilly Lung Cancer Review
January 30, 2020
CMS Medicaid “Block Grant” Proposal Allows Formularies – But With Some “Protected” Classes
January 30, 2020
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