FDA Opens Docket On DMD Drug Development; Patient Group Proposal For Draft Guidance May Be Model For Future Classes

FDA Wants Testosterone Use Cut Back To Narrow Indications Or Sponsors To Do Major Clinical Work; Agenda for Sept. 17 Committee Meeting Is Harsh For Marketers

Advisory Committee Tracker: FDA’s Busy September Extends Beyond Panel Meetings

House 21st Century Cures Resource Guide: Key Themes To Watch As Listening Phase Draws To A Close

Generic Drug GDUFA Deadlines for Responses To Sponsors Will Not Apply to Some Requests: BE Guidances; Citizen Petitions

FDA’s Tougher Line On NDA Amendments: Policy Manual on Review Milestones Stresses Complete Initial Filings

Advisory Committee Trends: Panels Voting “Yes” Just Over Half The Time in 2014; NMEs Far Better, But Not Like 2013

DEA Finalizes Rescheduling Hydrocodone Combo Products to Schedule II; Industry Has 45 Days to Prepare

FDA Subgroup Data Action Plan: Implications for Future FDA Funding Requests – Maybe For “Off-Label” Promotion

DEA Scheduling Still Holding Up Merck’s Suvorexant Despite Head Start; Another Case Study To Support Reform Bills

GDUFA Public Policy Hearing: FDA Raises Possibility of Public Process for 180-Day Exclusivity Eligibility Considerations

BI’s COPD Treatment Spiriva Respimat: Panel Recommendation Bodes Well for Future Tiotropum/Olodaterol Combo

Revised Clinical Pharmacology Labeling Guidance Clarifies How and Where to Present Data

FDA Therapeutic Proteins Immunogenicity Guidance Highlights Specific Risk Mitigation Recommendations

GAO Study Lists Five Drug Treatments As Cost-Saving, Including Prevention Of ESRD In Type 2 Diabetes

BI’s Spiriva Respimat: FDA Committee Asked Whether 17,000- Patient TIOSPIR Trial Answers Mortality, CV Concerns

FDA/NIH Workshopping Antibiotic Stimulus Effort: More Obama Administration Attention Likely

FDA Looks At Data Access Plans to Make Use of Interim Results Viable In CV Outcomes Trials

Medicare Discussion Draft Released By Ways & Means; Requires Common Rule Guidance, Allows For Part D Lock-Ins

Confidentiality of Interim Results in CV Outcomes Trials: Broad FDA Representation At Public Hearing

Botulinum Toxins for Facial Wrinkles Guidance Outlines Pathway for Smooth Product Development

CMS Rejects New Tech Add-On Rate for Durata’s Dalvance But Reaffirms That NTAPs Can Be Based on Non-inferiority Trials

Biologic Reference Product Exclusivity: Guidance Outlines Excluded Products But Can’t Truly Answer What Is “New”

Female Sexual Dysfunction Patient-Focused Drug Development Meeting Set For Late October; Paired with Scientific Workshop

Biosimilars Naming: Senate HELP Letter May Be First Public Hint At Unique Non-Proprietary Names