CDC Antibiotic Resistance Report Prioritizes Worst Microorganisms, Supports CDC Budget, LPAD Legislative Push

FDA End-of-Phase I/Phase II Meeting Guidance Will Contain Directives on Patient Exclusions

FDA Patient Network Meeting: Update on Patient Participation in FDA/Sponsor Meetings, Patient-Input Meetings

House Compounding Bill Introduced, Closer to Senate Model: Defines “Outsourcing Facilities,” Requires Registration and Fees

Perjeta Early-Stage Breast Cancer Use Clears FDA Panel—After Genentech Agrees To Pull Claim If Confirmatory Trial Fails

Companion Diagnostics for Breakthrough Therapies: Proposals to Speed Reviews Can Largely Use Existing FDA Framework

GSK/Theravance Anoro Clears Committee Easily, But With Post-Marketing Study That Neither FDA Nor Sponsor Wants

FDA Orders Opioid Re-Labeling: Is “Severe Enough” Pain Indication Good Enough To Mollify Critics, Maintain Access?

Roche Perjeta Likely Headed to Neoadjuvant Approval; FDA Panel Focus Will Be Limits For pCR Endpoint For Other Agents

CDER Emphasis On Drug Quality Regulation Gets Boost in Agency-wide “Program Alignment” Restructuring Effort

Diabetes ADE Action Plan: HHS Targets Hypoglycemia Events In Lieu Of CV Risks, Pancreatitis

FDA Issues Generic Advair Guidance: Step Forward For Generics; Clinical Studies Next Hurdle

Anticoagulant Under-Use Highlighted In HHS Adverse Event Action Plan; Opportunity For New Agents Vs. Warfarin

GSK Anoro Ellipta COPD Combo: Smooth FDA Panel Review Likely, CV Concerns “Unremarkable”

Medicare Considers Coverage For Hep C Screening; Review Should Provide Timely Boost For Launch Of New Agents

Opioids ADE Action Plan: Improve Metrics and Surveillance, No Push to Tie DEA Registration to Provider Education

HHS Adverse Event Action Plan Aligns Well With FDA Sentinel And Safe Use Initiatives – But Emphasizes CMS, Other Agencies

FDA Diabetes Team Leader Guettier Will Be Acting Director of E&M Division; Four-Year FDA Veteran Advancing Rapidly

Round Two Of FDA Quality Initiative Coming: Agency Wants CEO-Level Focus On Manufacturing

Advisory Committee Tracker: Landmark Applications From GSK and Roche Highlight September Schedule; Hep C Set for October

FDA Announces $2 Mil. Grant to Support CFAST Efficacy Data Standardization: C-Path Is Lead Partner

Beyond Compounding: Biopharma Legislation as Congress Returns from Recess

Biopharma Policy Fall Preview: FDA Climate Still Good—But Not As Good; Compounding Is Key Hill Topic For Fall

Part D Fraud & Abuse Bill: Allow Plans to Limit Individuals’ Coverage to Designated Prescribers, Deny Payment for Drugs

REMS to Block Generics: FDA Promises Guidance, But Declines To Take Immediate Action To Resolve Access Issues