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

Prevision Policy Clips | Senate HELP NIH Hearing Aug. 23

EpiPen Approval May Signal Substitutable Generic Advair May Be Close

Prevision Policy Clips | CRL Four-Day Turnaround?

Prevision Policy Clips | FDA, NIH Propose Removing RAC Review for Gene Therapies

Prevision Policy Clips | FDA's Woodcock Makes The Case For Randomization In RWE Studies

HHS OIG On Open Payments: Some NDCs And Product Names Missing In System, But Less Than 1% Of Overall Records Incomplete

“One Continuous Trial” In Oncology: Expansion Cohorts Guidance Outlines FDA Thinking on When and How To Expand First-In-Human Trials

Prevision Policy Clips | Acting OND Chief Of Staff To Be Khushboo Sharma as Patrick Frey Leaves FDA For Amgen

FDA Continuing Biomarker Efforts with Decision Science Team Pilot; “Cures” Drug Development Tool Process Meeting Planned For December

Prevision Policy Clips | FDA Approves Alnylam’s Onpattro, First FDA Approval of an siRNA

Prevision Policy Clips | Safe Harbor Drug Rebate Rule: Hatch, Walden Ask OMB For Economic Analysis

Medicaid Line Extension Rebate Guidance Details Post-BBA Calculations As Azar Ramps Up The Rhetoric; Rulemaking Coming

Prevision Policy Clips | Apotex Potassium Chloride Becomes First CGT Approved, Follows Amneal ANDA Approval

Paratek’s Omadacycline Clears Advisory Committee Meeting For ABSSSI and CABP; Panelists Push for Randomized Postmarketing Trial to Look at Mortality Imbalance

Opioid Use Disorder Guidance: FDA Expands Clinical Endpoints, Builds On April PFDD Meeting

FDA Wants You: Streamlined Hiring Pilot Kicks Off After Delay, Recruiting For “Cures”-Funded Positions Restarts After HHS Review

Prevision Policy Clips | Express Scripts’ 2019 Preferred Formulary Excludes Gilead’s HIV drug Atripla

Insmed’s Amikacin Inhaled Antibiotic Wins Support From FDA Advisory Committee For Use In Refractory Patients; Surrogate Endpoint Is More Of A Question Mark

CMS To Allow Step Therapy In Part B For MA Plans In 2019, Targeting $2.4 Bil. In Annual Savings

TIRF REMS Will Be Modified To Address “Gaps” As Program Oversight Receives Commissioner-Level Attention

Broad Range of FDA Participants Get Platform At Alport Syndrome PFDD Meeting

Prevision Policy Clips | Elemental Impurities Final Guidance

Paratek’s Omadacycline for ABSSSI and CABP: Positive Panel Review Likely for Both Uses But FDA Notes Mortality Imbalance in Pneumonia Trial

Prevision Policy Clips | Remoxy Receives Fourth FDA “Complete Response”