E&C “21st Century Cures” Clinical Trial Session Focuses on Master Protocol and Networks; Adaptive Licensing in Background

Pediatric Rare Disease Strategic Plan: FDA Working on Five Relevant Guidances, Including BPCA, PREA Guidances

First CBER Patient-Focused Drug Development Meeting to Look at Hemophilia, Other Heritable Bleeding Disorders

Hepatitis C Webinar Highlights “Real World” Research Priorities To Show Effectiveness and Value of New Treatments

IPF Patient Meeting In September To Look At “Ideal Treatment” Absent A Cure

FDA Finalized Tropical Diseases Guidance Highlights “Breakthrough” and QIDP Designations

FDA “Do-Not-Compound” List Starts With 84 Products Withdrawn for Safety Reasons, Including OxyContin

FDA Issues Outsourcing Facility GMP Guidance, Finalizes Pharmacy Compounding Guidance

“Smart Regulation”: FDA Strategic Plan Stresses Better Management, Consumer Communication

Advisory Committee Tracker: Baxter/Halozyme, BI Line Extensions Added To Summer Agenda

AstraZeneca Olaparib for Ovarian Cancer: Regulatory Flexibility Can Go Only So Far In Cancer, ODAC Rejection Shows

Rep. Waxman Presses Criticism of Sovaldi Pricing At Medicare Hearing; Still No Sign Of Action By House Majority

Adherence, Clinical Trial Recruitment Opportunities Highlighted During House “21st Century Cures” Roundtable on Digital Health

Antibiotic Incentives Update: FDA/NIH Meeting on Streamlined Pathways Set For July; HHS Report Highlights Incentive Gaps

AstraZeneca Ovarian Cancer Therapy Olaparib: ODAC Has Enough For A “Yes,” But Concerns About A Precedent Loom

Legislators Urge Data Transparency on Women and Minorities in Clinical Trials in Letter to NIH

White House Drug Abuse Summit: Addiction Treatment Options, Hep C Screening Get More Attention Than Zohydro

Rep. Waxman Sovaldi Follow-Up Focuses On Medicare Part D; Emphasis Still More Rhetorical Than Substantive

Exchange Plan Report From HHS Has Mixed News For Biopharma

FDA Likes Facebook? Social Media Guidance On Character Limits Favors Sites With Fewer Constraints Than Twitter

FDA Social Media Guidance Allows Targeted Corrections By Sponsors; Narrow Scope But Important New Flexibility

FDA Seeks Input on Post-Approval Studies to Assess Cancer Risk: Sept. 10-11 Meeting With NCI

A Double-Edged Sword? House Hearing Focuses on Drug Coverage In Exchanges With Cost Data

Exclusivity Incentives Highlighted at 21st Century Cures Hearing: Focus is Length and Qualifying Products—Not Value of Extension

FDA Panel Opposes CV Outcomes Standard For OIC Therapies; Post-Market, Observational Studies Likely To Suffice