Senate Compounding Bill Revised: “Biologics” Given Separate Status; Avastin Re-Packaging Likely Still Permitted

Track and Trace Bill Passes Energy & Commerce; Defeated Amendments Keep It Moving, But Remain Issues for Conference

FDA’s HIV Patient-Input Meeting on June 14: Focus Will Be Untreated Symptoms and Cure Research

Senate Part D Hearing Set for May 22: Forum for Rebate Debate, But Also For Adherence, Medication Management Discussion

Eliquis sNDA for Prophylaxis of DVT Following Hip or Knee Replacement Surgery

Endo Opana ER Generics Remain: FDA Doubts Abuse-Deterrence of Formulation; Endo Postmarket Data is Immature, More Time May Help

Pharmacy Compounding: Senate Draft Getting Closer to Markup, But Issues Divide Stakeholders in Hearing

FDA Expanded Access Q&A Highlights Emerging Theme of Patient Feedback Era; Will Advocates Push Pharma To Do More?

ADUFA and Track and Trace Clear House Subcommittee; Bills on Parallel—but Still Separate—Tracks

Arena’s Belviq Finally Gets DEA Scheduling; Lag-Time Has Implications for Merck’s Suvorexant

House Track and Trace Bill Would Push Unit Tracking To 2027; Moves Other Pedigree Deadlines Forward

Delcath Melblez Rejected By FDA Advisory Committee; New Study With Improved Device Needs To Show Less Toxicity

CFS/ME Patient Input Meeting Will Jumpstart FDA Guidance Effort

Aveo’s Tivozanib: FDA Advisory Committee Is Over Before It Starts As Negative Survival Trend Trumps All

HHS’ Howard Becomes Deputy at FDA; Personnel Changes Cement Close Ties Between FDA and HHS Leadership

Aveo’s Tivozanib for Advanced Renal Cell Carcinoma: Negative Survival Trend Likely Too Much To Overcome At ODAC

Delcath Melblez Appears Headed To “No” Vote at FDA Panel; New Study Likely Needed to Validate Device, Confirm Benefit

FDA Appropriations Hearing Features Calls to Undo User Fee Sequestration; Compounding, Abuse Continue to Be Key

FDA Patient Input Inaugural Meeting Performs Best on Symptom Collection in CFS/ME

Senate Compounding Draft Includes User Fees; Sponsors Tout “Bright Line” Definition of “Compounding Manufacturer”

E&C Track and Trace Hearing: Support for Adding Timeline for Unit-Level System to House Discussion Draft

Advisory Committee Tracker: Merck Sleep Aid Highlights May Meetings; Delcath Waivers Suggest Tough Time at ODAC

Track and Trace Draft Legislation Released Ahead of Thursday House Hearing; Senate Bill Requires Eventual Unit-Level Tracing

Medicare Part B Sequester Impact: HHS Secretary Says Zero Flexibility Around Drug Cuts

Senate Appropriations Hearing: FDA Fields Questions on Compounding, Sequestration Impact on User Fees