FDA Cuts Off One Route For Acthar Competitors As FTC Opens Up Another One

FDA Oncology Center Launches: How Far Will Separation Of Cancer Reviews From Rest Of FDA Go?

HHS Nominee Price: Noncommittal On Direct Part D Price Negotiation and Transparency, Some Support For CMMI

The Alexander ACA Plan: Rescue, Replacements, Repeal

Final “Common Rule” Drops Expansion to Private Trials, Application to Research with Non-Identified Biospecimens

FDA First Amendment Memo Defends The Status Quo: Trump FDA (and Supreme Court) Likely To Take Different View

FDA Guidance On Rx/Payor Communication Allows More “On-Label” Claims; “Just-The-Facts” For Preapproval Communication

Human Abuse Liability Studies Get Detailed Treatment in Abuse Potential Assessment Final Guidance

FDA Off-Label Guidance Opens Narrow Window For Promotion; Communication Of New Data Within Approved Uses Is OK

FDA Interchangeable Biosimilar Guidance: Switching Studies Needed; Post-Market Data Helpful, Not Sufficient; No Bridging

Late-Phase Development, NDA Submission Recommendations Updated in Final Botanical Drug Development Guidance

Weekly Highlights: January 9-13

FDA’s 180-Day Exclusivity Draft Guidance Outlines Forfeiture Timelines For ANDA First Applicants; Clarifies Existing Policy

FDA Repackaging Guidance Updated: Agency Still Permits Routine Compounding Of Avastin, But Notes Safety Issue

Biologics Naming Guidance Finalized: Nonsense Suffixes Will Be Applied; Policy For Interchangeables Still Under Consideration

Peter Thiel’s FDA? Trump Advisor May Have Other Silicon Valley Candidates For Drug/Device Regulatory Agency

FDA Advisory Committee Tracker: Where Are All The Meetings? Neurocrine Cancellation Leaves Empty Calendar For Reviews

HHS IG Report On Catastrophic Drug Spending Highlights A Flaw In Part D Success Story; No Immediate Impact

Weekly Highlights: January 3-6

Biogen Spinraza Approval For Rare Neurological Disease Shows FDA-Preferred Model for Orphans; Antidote To Sarepta?

HRSA Finalizes 340B Civil Money Penalty Rule: “Penny Pricing” Policy Affirmed; Is “Mega-Guidance” Next To Come Out?

NIH Funding In Cures: Obama Priorities “Trump” House Approach

“Cures” Vs. FDAAA: New Law Shows How Times Have Changed

FDA Advisory Committee Trends: Panels Voted “Yes” 87% Of The Time In 2016; Just 9 of 23 Meetings Were for Novel Drugs/Biologics

FDA Holds To Stepwise Development Strategy For Biosimilars In Final Clinical Pharmacology Guidance