NIH Gets Big Dollar Boost; FDA Gets Hiring Flexibility Under 21st Century Cures 2nd Draft

FDA Wish List In “Cures”: Patient Input Provision Locked Down; Biomarker, Antibiotic Provisions Getting Closer

Filling In The Blanks On “Cures” Bill: Dormant Therapies, Lab Tests Are Priorities For New Drafts; What About FDA Resources?

Amgen T-Vec Melanoma Therapy Clears FDA Committee: Panel Votes For Broad Label; FDA May Have Other Ideas

21st Century Cures Part II: Big Pro-Biopharma Ideas Have To Wait For 2017

FDA Finalizes First Biosimilar Guidances: Minor Revisions Reflect Maturing Pathway; Interchangeability, Naming Not Addressed

The “PATH” To FDA Reforms: FDA’s Woodcock Lauds Antibiotic Bill At Senate Hearing; House “Cures” Draft Still Pending

Advisory Committee Tracker: Vertex CF Therapy Highlights May; Summer Reviews Likely For PCSK9s, DMD; Where’s Infliximab?

Breakthrough Fees In FDA’s Sights For Legislative Fix: PDUFA VI, Maybe 21st Century Cures

Amgen T-Vec Melanoma Therapy: FDA Review Suggests Limited Indication Likely To Win Advisory Committee Support

House Opioid Hearing Emphasizes Importance of Medication-Assisted Treatment as an Option for Addiction

FDA/CMS Parallel Review Program Is “Priority” for CMS Coverage Group, Fed Reg Notice Coming In December 2015

Electronic Reporting Of Promotional Material: Perfunctory Guidance Reinforces FDA’s Assertion of Authority

FDA in Caretaker Mode: Breakthroughs Keep Moving; Opioids, Antibiotics Stay in Spotlight

FDA Finalizes Lung Cancer Endpoint Guidance: Clarifies Thinking on PFS Versus Overall Survival, Notes PRO Endpoint

GDUFA II Kick-Off Meeting Set For June: Let the Saber-Rattling Begin

FDA Copaxone Generic Approval Shows Agency Persistence On Tough-To-Copy Products; Momenta Praises New FDA Structure

CDER Office Of Pharmaceutical Quality Manifesto Offers Manufacturing Flexibility As Potential Regulatory Upside

TMC’s Cangrelor Approval Vote Based On FDA, Committee View That Drug Improves Current PCI Drug Practice

CV Safety Confirmed For AZ, Takeda DPP4 Diabetes Drugs; New Labeling Urged For Potential Heart Failure Risk

TMC Cangrelor Reprise At FDA Cardio-Renal Committee Appears Likely To Earn OK But Fans Debate On Medical Reasonableness

Part D Overutilization Policy Building Toward Use In More Classes

CV Outcomes Trials In Diabetes: FDA Panel Will Focus On Heart Failure Signal For DPP4s; AZ Has Tougher Task Than Takeda

Lung Cancer Patient Preference Study At Hopkins Grows From FDA Patient-Input Meetings; Shows Impact of FDA Initiative

REMS Modification Guidance Allows Editorial Revision Without FDA Review, Streamlined Action On “Minor” Changes