FDA Patient Network Meeting In September Will Offer Forum For Broader Array Of Patient Advocates

FDA Finalizes Safety Labeling Changes Guidance: “New Safety Information” Tweaked, Generics May Trigger Modifications

Clinical Trial Monitoring Guidance Reinforces Centralized Monitoring Paradigm Shift, Provides More Details On Specific Strategies

Bayer’s Riociguat: Unanimous Votes for Dual Indication and Support for Max Range Dosing Represent a Near-Perfect Outcome for Bayer; Will FDA Stand Firm?

Otsuka’s Tolvaptan: Severe Liver Risk, Not Enough Efficacy Lead to FDA Panel Rejection

FDA Provides More Details On Breakthrough Therapy, Expedited Review Programs Guidance

CMS Issues New National Coverage Determination Policy Reiterating FDA Approval “Does Not Entitle” Medicare Coverage

Bayer’s Riociguat for PAH and CTEPH: FDA Recommends Approvals With Dosing, Label Modifications Ahead Of Panel Review

No Applications? No Problem: Biosimilars User Fees To Rise In FY 2014 Due To PDUFA Tie-In

Otsuka’s Tolvaptan: FDA Reviewers Recommend Against Approval Ahead of Panel Meeting Due to Liver Toxicity

Nasacort OTC Switch: Nonprescription Drugs Advisory Committee Recommends Approval; Slowed Growth Concern Can Be Addressed In Labeling

GAO Says Congress Should Consider Compounding Legislation, Report Released as Senate Bill Waits for Floor Action

RA Guidance Webinar: Context on Clinical Remission, MRI Endpoint, and Dose Selection

HIV Guidance Webinar Reiterates Key Development Approach Changes

Advisory Committee Tracker: Summer Gets Slower Thanks To Data Integrity Issues; First “Program” Review Highlights August

Nasacort Rx-to-OTC Switch Advisory Committee Preview: FDA Says Corticosteroid A “Good Candidate” For Nonprescription Use

FDA’s Two-Day REMS Meeting: Top Level Participation Absent as Stakeholders Look Ahead to Next Phase of REMS

Senate Compounding Bill Heads To Floor: New Draft Clarifies Avastin Role, Muddies Makena Status

Senate Pay-for-Delay Hearing: FTC Will Focus On Existing Cases With Odds For Legislation Decreasing

FDA Committee Supports Broader Back Pain Use for TNF Class: UCB’s Cimzia Gets Yes Vote; Abbvie’s Humira Needs More Work

340B Orphan Drug Rule Maintains Narrow Exemption From Discounts; Audits May Assure Limited Impact On Manufacturers

Ryan White HIV Assistance: Revision, Restructure, Reconfiguration Arguments To Avoid Program Sunset

Narcolepsy Patient-Focused Meeting Suggests that FDA has Found a Formula; “Access Issues” Will Be One Topic To Watch

340B And The ACA: Drug Discount Program Well-Defended Through 2014; Reforms Unlikely Before 2015 Or Later

House Compounding Hearing: Issues Remain on Defining Problem Compounders, Whether to Define a Third Category