Guidance Requirements in FDASIA and the User Fee Agreements

Onyx Kyprolis (Carfilzomib) Gets Accelerated Approval Recommendation from Committee, Has FDA Oncology Office Support

Advisory Committee Votes Down Sanofi’s Semuloparin for VTE Prophylaxis in Cancer Patients, Target Population Needs Further Defining

FDA Safety and Innovation Act: Overview of Noteworthy Provisions

Final User Fee Bill Released; Includes House, Not Senate, Pay-For, Less Broadly Defined Antibiotic Incentive Language

FDA Concern Over Inability to Predict Toxicities Clouds Accelerated Approval Review for Onyx’ Kyprolis

FDA Questions Efficacy, Target Population of Sanofi’s Semuloparin for VTE Prophylaxis in Cancer Patients

Get With “The Program”: The New Drug Review Process Under PDUFA V

FDA Retains Dal Pan as Drug Safety Director: Choice Signals Stability

REMS Assessment FDA Workshop: Input for Guidance; Long Way to Go on What and How to Assess and Reasonableness of Timelines

Inspections and Drug Shortages: Is There A Correlation?

Advisory Committee Tracker: Spring Thaw? More “Yes” Votes in May, But Panels Still Trend Negative

House User Fee Bill Local Acting Bioequivalence Provision Gets Attention, Potential for Removal During Negotiation Process

House Passes Its User Fee Bill; Now On To Negotiations

Accelerated Approval for High-Risk Breast Cancers: One Trial May Suffice

Pfizer’s Tafamidis: Failed Trial Succeeds In Persuading Advisory Committee; Will FDA “Flexibility” Stretch That Far?

User Fee Bill Passes Senate; Several Amendments Added, No Pay-For-Delay Reform or Drug Reimportation

J&J/Bayer Xarelto ACS Indication Faces Hurdle of 6-4-1 Negative Vote By Cardio-Renal Advisory Committee

Pfizer’s Tafamadis Faces Tough FDA Panel Review: Classic Test of Orphan Drug “Flexibility” at FDA

Drug Review Dossier: canagliflozin

Drug Review Dossier: Kynamro

Drug Review Dossier: enzalutamide

J&J/Bayer Xarelto for ACS: FDA Reviewer Recommends Approval, But No Mortality Claim

Patient Input In FDA Drug Reviews: Pre-IND and Pre-Filing Are the Early Focus

Coverage With Evidence Development: MEDCAC Discussion Underscores Focus on Devices; Biopharma Impact 3-5 Years Out