Prevision Policy Clips | Certificates of Confidentiality Draft Guidance

Pazdur’s OCE: The Benefits and Risks of Going It Alone At FDA

Prevision Policy Clips | Grassley, Wyden Still Searching For 60 Votes On Drug Pricing Bill

FDA Regulatory Agenda Includes No Surprises For Year Ahead; Seven Actions By End Of 2019

FDA Nominee Hahn Has Smooth Confirmation Hearing: What We Learned About The Potential New Commissioner

FDA Core Clinical Outcome Assessment Projects Will Draw On Existing Work: First Three Grants Draw On NIH Work On Physical Function And Pain In Children

Prevision Policy Clips | Transdermal/Topical Delivery Systems Subject Of FDA Draft Guidance

Novo Frames Rybelus Oral Semaglutide Price In Context Of GLP-1 Class, Not Other Oral Anti-Diabetes Agents; ICER Meeting Looks At Impact Of New Formulation

Prevision Policy Clips | House Judiciary Committee Will Mark Up Two Drug-Related Bills Nov. 20

Gene Therapy Trial Designs: Endpoints and Biomarkers are Key Issues; Other Suggestions For Improvement -- First-In-Human Dosing, Expanding Inclusiveness in Trials

Prevision Policy Clips | Janssen Stelara Medicare Expenditure Investigation

Prevision Policy Clips | White House Health Transparency Event: Will Drug Prices Come Up?

Amarin Vascepa CV Outcomes Claim Clears Committee; Label Likely To Reflect REDUCE-IT Study Population – Broad, But Not Quite As Broad As Proposed

BI Empagliflozin For Type I Diabetes Falls To Lopsided Committee Vote: Uncertainty About HbA1c Durability And DKA Data Prevail

FDA’s Safety Handbook: Postmarket Surveillance Principles Outlined In Best Practices Master Document

Prevision Policy Clips | Senate Finance Health Care Subcommittee Alzheimer’s Hearing Nov. 20

Chikungunya Vaccine Development: Non-Human Primate Model Should Be Focus For Identifying Immune Markers, Committee Concludes

House “Sham” Citizen Petition Bill May Be Amended Before Markup By E&C Committee; Republicans Question Constitutionally Of “STOP GAMES” Act

ICER Value Assessment For Curative Therapies Will Include “Shared Savings” Models; Hemophilia A, Sickle Cell Gene Therapies Could Be Among First Reviews

Medicare Part B IPI Proposal Will Attempt To Give U.S. Lowest International Price, HHS Secretary Says; OMB Review Still Pending

Prevision Policy Clips | Project Orbis Key To Launch: “I Just Decided To Do It”

ODAC “Point/Counterpoint”: FDA Oncology Pilot Will Highlight Points Of Disagreement Directly For Advisory Committee

Nothing Fishy About It: FDA Ready To Approve Amarin REDUCE-IT Claim, Says Mineral Oil Is Red Herring; Committee Review Will Highlight Key Labeling Points

Prevision Policy Clips | Medicare Part B Premiums Increase 6.7% For 2020; CMS Blames Drug Prices

BI/Lilly Empagliflozin For Type 1 Diabetes: FDA Asks Ad Com If Clinical Effect Is Too Small; 2.5 mg Dose Proposed Based On One Study