FDA Clinical Outcomes Meeting Will Address Political Liability: Few Results From Efforts To Qualify Patient-Based Endpoints

GAO Report on Drug Shortages Shines Light On FDA/DEA Coordination; May Add Support To Push For Legislation

FDA Derm Committee Urges Atopic Dermatitis Pediatric Studies “As Early As Safe”: Regeneron Compound Forces Issue

Senate “21st Century Cures” Process Kicks Off With Smaller Scale Themes: Targeted Reforms For Targeted Therapies?

Kythera Double-Chin Drug Clears FDA Panel: Endpoint Effort Pays Off; Fat Dissolution At Other Sites May Not Fare So Well

FDA Outlines “Expedited” Review For Breakthrough Therapies; “Hyper-Fast” Reviews Ready To Break Out Beyond Oncology?

First FDA Biosimilar Approval Defines “Highly Similar” In Broad Terms, But Still Requires Suffixed Nonproprietary Name

Vaccine Advisory Committee Accepts WHO Recommendations; New H3N2 and B-Type Strains

Kythera Injectable for Double Chin Gets Positive FDA Preview; Endpoint Development Key To Review

340B Hearing Postponed By Weather: Testimony Highlights Progress On Compliance, Importance Of “Mega Guidance”

House FDA Hearing Highlights Hamburg’s Legacy, Brings Questions On Abuse Deterrence And Biosimilar Guidances

Testosterone Label Update: FDA Wants Class Warning, Outcomes Trial; Sponsors Have Until March 10 To Respond

NIH Appropriations Hearing Underscores Support For Funding Increase; Rx Abuse, Antibiotic Resistance Efforts Discussed

FDA/NIH Dystrophin Biomarker Workshop Set As DMD Applications Near; Underscores Uncertainty of Endpoint

E&C HHS Budget Hearing Grazes Biopharma Issues But Focus on King v. Burwell Contingency Plan Intensifies

Tiered Formularies In Exchange Plans, 340B User Fees, Rx Drug Abuse Highlighted At House HHS Approps Hearing

Avedro CXL Therapy Clears FDA Committee: “Abysmal” Study Good Enough For Approval Vote; Still Uncertainty At FDA

Pharmacy Compounding Committee Adopts FDA Bulk Drug Substances Recommendations, Sets Tone For Future Reviews

Biopharma Gains Ground On ACA Formularies: Finalized Rule Strengthens Protections For Drug Coverage

Advisory Committee Tracker: Amgen’s T-VEC Tests Climate For “Non-Breakthroughs”; Breo Supplement Tests Safety Tolerance

Pharmacy Compounding Committee Strongly Supports FDA, Limits Compounding On 27 Withdrawn Products

“Chronic Fatigue” Reboot Would Start With New Name, New Diagnostic Criteria: SEID To Replace CFS/ME

Avedro Ophthalmic Drug/Device Faces Last Hurdle In Long FDA Review: Questions To Joint Panel Suggest Approval Likely

FDA Medical Policy Acting Director Jarow Brings Oncology Perspective: “Try Out” May Coincide With Off-Label Guidances

Pharmacy Compounding Ingredient List: FDA Process Will Limit Gray Market Options, But Divert New Drug Review Staff