Nicotine Replacement Therapies: FDA Standards For New Indications Will Be Hard Habit To Break; Longer-Use Regimens Appear More Achievable

Opioid Policy Steering Committee Contemplates Potential FDA Action on Prescribing, Participants Highlight Need for Interlinked State PDMPs, Streamlined Prescriber Access

"Prices Will Come Down": Translating Trump's Drug Pricing Rhetoric Into A Course Of Action At Azar's HHS - What Will, Could, And Won't Happen Next

Prevision Policy Clips | House Energy & Commerce to Hold Series of Opioid-Related Legislative Hearings

FDA and Digital Health: High-Level Excitement For Precertification, But Progress Will Be Tempered; FDA “Not Lowering The Bar” For Approval

Advisory Committee Tracker: Another Big Month For Opioid Product And Policy Decisions; What Claims Are Appropriate?

Prevision Policy Clips | Amazon Health? Amazon Announces Partnership With JP Morgan and Berkshire Hathaway

Prevision Policy Clips | HHS Secretary Azar Swearing In Ceremony Today

Spark's Luxturna ICER Review Offers Details Of Outcomes-Based Contracts, PBM Views On Installment Payments

FDA Hypertension Fixed-Dose Combo Guidance: Short With Suite of Two Alternatives To Full Factorial Studies

Prevision Policy Clips | FDA Formally Drops Biennial Inspection Policy For Biologics

CSL/Seqirus Pushes For $535 Mil. Annual Pandemic Flu Funding In PAHPA Reauth: Update Stockpile, Support Domestic Facilities

Prevision Policy Clips | “Hypertension: Developing Fixed-Dose Combination Drugs for Treatment” FDA Draft Guidance Available

HHS Secretary Nominee Azar Clears Senate; Democratic Opposition Keeping Azar's Feet To The Fire, But Letting Him Take The Job

MedPAC Part D Discussion Includes Claim Of Low "Breakthrough" Evidence Bar; Donut Hole Discount For Biosimilars Receives Full Support

Prevision Policy Clips | Senate Set To Confirm Alex Azar as HHS Secretary

Prior Authorization Policy: Under-The-Radar Effort To Streamline Approvals Could Be Pivotal In Context Of Copay Reform

Prevision Policy Clips | Gene Therapy Guidances Dominate CBER 2018 Agenda; Hemophilia Gets Top Billing

Gene Therapy Guidances Dominate CBER 2018 Agenda; Hemophilia Gets Top Billing

Prevision Policy Clips | No New NDAs During Shutdown

CDER 2018 Guidance Agenda Includes ALS, Early Alzheimer’s; No Biosimilar-Specific Guidances Listed

FDA Partial Shutdown Would Have Minimal Short-Term Impact on Drug Reviews; Long Term Threat to Morale Should Not Be Overlooked

FDA Compounding Policy: Agency Floats Hospital Carve-Out; Footnotes Are Foot In Door To New Way To Address Shortages, Market Failures For Approved Drugs

Prevision Policy Clips | CDER Guidance Agenda for 2018 Includes ALS and Early Onset Alzheimer's Drug Development Guidances

Priority Review Vouchers Have Diminishing Value As Development Incentive; Gottlieb Tells Senate Hearing: FDA Using Other Techniques