Weekly Highlights: October 2 - October 7

CDER Policy Office Has New Head: NIH’s Corrigan-Curay Brings Decade Of Experience With rDNA Advisory Committee

Naloxone Dose Increase Supported By Slim Margin At FDA AdCom; Confuses Route For New Community Use Products

ANDA/505(b)(2) Mega Rule Eases Generic Carve-Out Approvals, Clarifies Rulings That Terminate 30-Month Stays

Abuse-Deterrent Formulations: FDA Wants To Harmonize In Vitro Test Standards As Part Of Efforts To Enable ANDAs

FDAAA Trends: REMS Use At New Low, Post-Marketing Study Requirements Continue To Decline; “Deemed” REMS Complete

Part B Demo Could Save Up To $2.2 Billion Over 10 Years, CBO Estimates; Blocking Demo Would Score Much Less

Naloxone FDA Review Oct. 5 Pits Public Health Benefits of Broader Distribution Vs. Product Features, Potential Confusion

Advisory Committee Tracker: FDA Re-Visiting Low-T In December; Few Drug-Specific Reviews On Calendar For End Of 2016

Transplant Drug Adherence Probed By FDA During Patient Meeting; Agency Prepares For Further Dosage Improvements

Weekly Highlights: September 26 - September 30

FDA Encouraging Pediatric Master Protocol Development; Draft Templates Are Starting Point For Collaboration

CAP’s “Negotiation Plus” Plan Includes Two Outside CER Reviews, Recommended “Price Range” and Arbitration

Pediatric Priority Review Voucher Extension Likely; Voucher Opponents Focus On NIH Funding, Drug Prices – Not FDA Concerns

FDA Prognostic Biomarker Qualification Push: Guidances Finalized for Plasma Fibrinogen In COPD, Total Kidney Volume

Weekly Highlights: September 19 - September 23

Drug Pricing And Opioid Response Converge at House Hearing; Encouraging Addiction Therapy Remains Dominant Theme

GDUFA II Creates “Complex Generic” Pathway, But Simplifies Review Goals Overall; 8-Month “Priority” ANDA Timeline Set

“Right To Try” Hearing Spotlights Adverse Events As Key Barrier; FDA, Industry Share Interest In Showing Expanded Access Works

Generic Approvals: FDA Tells Congress Bad Applications Are Big Reason For Slow Reviews Amid Questions About EpiPen

EpiPen Pricing Transparency, Access Program Take Center Stage In House Hearing; Mylan Medicaid Rebates Also Draw Questions

HHS Clinical Trials Final Rule Changes Applicable Trials Definition, Excludes Expanded Access

FDA REMS Standards Guidance Sets Broad Criteria For Rarely Used Tool; Agency Restraint, Not Regulatory Constraints, Limits Use

The Eteplirsen Precedent: Flexibility For Rare Diseases Versus “Unusual” Internal Appeal; FDA Fallout Key To Watch

Biosimilar Interchangeability Guidance Now Due By End of 2017; BsUFA II Commitment Letter Doubles Length of BsUFA I