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

OND Feedback Meeting: New Division Director Line-Up Debuts In Listening Mode; Key Theme Is Be More Like Oncology

Merck Seeking Add-On Payment For Five-Year-Old Antibiotic; Seven Anti-Infectives, Two CAR-Ts Among Those Seeking NTAP Status In 2021

DoD and VA Drug Procurement Should Prefer Domestic Production, Witnesses Tell House Supply Chain Hearing; Over-Reliance On Chinese Supply Is Concern

Prevision Policy Clips | FDA Oncology Center Of Excellence Gains Patricia Keegan As Acting Associate Director

FDA’s Message On Manufacturing: GMP Adherence Is Not “Good Enough,” But Industry Will Have Chance To Shape “Quality Maturity” Program

FDA’s Office of Neuroscience Will Be Tested In 2020 With High-Visibility Reviews; Bastings To Lead Division Overseeing Alzheimer’s, DMD Drugs

Prevision Policy Clips | Can FDA Nominee Hahn Be Confirmed In Six Weeks?

ICER Reviews Are New Frontier For Patient Groups; Organizations Feel Compelled To Participate Despite Effort Required, Advocates Tell BIO

FDA Oncology Office Has Four New Division Directors, With Keegan Moving To OCE; Neurology, Infectious Disease Offices Have Fewer Changes; Most Deputies Are TBD

Prevision Policy Clips | FDA Seeks Comments On Best Practices Document For Drug/Biologic Postmarket Safety Surveillance

Prevision Policy Clips | The “New” OND: November 7 Launch Meeting Will Feature CDER Deputy Cavazzoni

FDA Working With BARDA On Mobile, On-Demand Manufacturing; Agency Is Looking At Regulatory Changes For Systems That Could Address Shortages

Prevision Policy Clips | CMS Maintains 340B Payment Cut, Exparel Payment Policies

Giroir’s FDA: New Acting Commissioner Has Strong Resume, Close Ties to HHS Secretary Azar; Tenure Could Be Prolonged If Hahn Confirmation Bogs Down