Drug Price Reforms Will Be Priority For HHS Under Azar: Early Test Will Be Lower Consumer Costs for Insulin; Part B Reforms May Be More Significant

FDA Oncology Supplements Set Model For Acceptance Of Broader Forms Of Evidence And Trial Design: OCE Leads Way In RWE

Prevision Policy Clips | FDA Nicotine Steering Committee to Modernize Approach to Nicotine Replacement Therapy

FDA Drug-Device Generic Guidance Will Allow Different Instructions For Use; Clears Hurdle For EpiPen, Advair Generics

Prevision Policy Clips | NASEM Drug Affordability Project Report To Be Released Nov. 30

Prevision Policy Clips | PCORI Approves $57 Mil. of Funding for 14 New Comparative Clinical Effectiveness Research Studies

Prevision Policy Clips | 21st Century Cures Act Implementation Update Hearing

FDA Compounding Committee Adds Liposomals and Products Produced Using Hot Melt Extrusion to “Difficult to Compound” List

Senate Gene Editing Hearing Praises “Robust” FDA Oversight; Coincides With Sangamo Hunter Disease Human Trial Start

FDA Simplifies Generic Abuse-Deterrent Pathway In Final Guidance; Progress Will Rely On “Complex” ANDA Route – Won’t Come Quickly

Prevision Policy Clips | General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products, Final Guidance

Prevision Policy Clips | 2018 Medicare Parts A & B Premiums and Deductibles Announced November 17

Bayer Ciprofloxacin Takes A Powder: Inhaler Version Rejected By FDA Advisory Committee; FDA Staff Less Harsh In Criticism of Failed Primary Endpoints

Prevision Policy Clips | Alex Azar’s HHS Secretary Nomination to be Discussed at Senate HELP Committee Hearing

FDA New Drug Reform: Pilot Programs Planned To Test More Efficient Processes; “Everything Is On The Table”

Part D Rule Fits Trump Drug Pricing Strategy; Focuses On Reducing Beneficiary Cost-Sharing Above All Else

FDA Finalizes Regenerative Therapy Regulatory Paradigm – But Sets Three-Year Transition Period For Compliance

FDA Releases Set Of Regenerative Medicine Advanced Therapy Guidances: Gene Therapy Qualifies For New Pathway – Not That It Matters Much

Biopharma Congress Takeaways: OCE To Remain Unique, Patient Functions Spreading At FDA; Drug Pricing Themes Continue

Prevision Policy Clips | FDA Announces Comprehensive Regenerative Medicine Policy Framework; Releases Four Guidances

HHS Nominee Azar Should Get A “Quick” Hearing, OMB’s Grogan Says; Drug Pricing Will Stay In Spotlight – But Not Price Controls

Prevision Policy Clips | FDAMA 114 Guidance Expected By End of 2017

Prevision Policy Clips | Alex Azar As Head of HHS Could Move Off-Label/Beyond Label Commercial Speech

Hyperhidrosis Patients Seek FDA-Approved Treatments For All Types Of Excessive Sweating; Botox Access An Issue

Prevision Policy Clips | FDA Expands ANDA Prioritization Policy