Pfizer’s Sutent: Split Vote Reflects Internal Struggle; Will Final Decision Signal A Regression To The Mean For ODAC?

FDA Patient Experience Staffing Strategy Includes Division-Level Expert Positions; “Kluetz-For-All” Approach

FDA Drug Pricing Response Moves Into Phase Two: Regulatory Efficiency To Reduce R&D “Cost Of Capital”

Prevision Policy Clips | Three Complex Generic Drug Product Meetings Hosted by FDA in October

Prevision Policy Clips | Gottlieb Says FDA Compounding Pharmacy Guidance Coming

Pfizer’s Sutent: A Tale of Two Trials At The Heart Of ODAC Review

Prevision Policy Clips | Amgen’s Mvasi, Biosimilar To Avastin, Becomes First Cancer Biosimilar Approval

Major Issues For Minor Labeling Change: Committee Gives FDA Wide Latitude On Handling Of Purdue Butrans Pediatric Study

MedPAC Interested In Expanding MA-PD Controls Over Specialty Drugs; Looking To Move Part B Specialty Drugs Under MA-PD

Prevision Policy Clips | GSK’s Shingrix Poised For Approval With Advantage Over Zostavax After Unanimous FDA Panel Recommendation

OTC User Fees Moving In Congress: FDA Highlights Safety Labeling As Key New Authority; Exclusivity To Be Worked Out

GSK’s Shingrix Poised For Approval With Advantage Over Zostavax After Unanimous FDA Panel Recommendation

PDUFA/BsUFA Fees Set: FDA Expects 13 Biosimilar Applications In 2018; Product Fee Is $300,000 Per Drug, Biologic Or Biosimilar

Pediatric Trial Design Workshop: FDA Will Show Maximum Flexibility For Drug Development In Children

ICER and the VA: Amgen’s Repatha FOURIER Outcomes Trial Will Indicate Impact of Recent Agreement

Alopecia Patient-Feedback Meeting Suggests High Bar For Efficacy: Significant Hair Regrowth; Pfizer’s Xeljanz Hailed As “Life-Changing”

Prevision Policy Clips | FY2018 BsUFA and PDUFA Rates Announced

FDA Committee Weighs Pediatric Labeling For Opioids; No Indication Coming For Purdue’s Butrans—But What Can The Label Say?

Prevision Policy Clips | ALS Guidance Among 10 Disease-Specific Documents Under Development At FDA

MRI Imaging Agent Safety Review: A Case Study In Containing Safety Issues In Pro-Innovation Era

GSK’s Shingrix: Smooth Sailing At VRBPAC Likely; GSK Pushing For Recognition On Efficacy Above 70; FDA Appears Less Inclined On That Point

Prevision Policy Clips | CBER Director Peter Marks added to Biopharma Congress agenda

Prevision Policy Clips | FDA Aims To Reduce Early Data, Cost Burdens For INDs

Prevision Policy Clips | FDA Seeks Public Input on Regulatory Reform Executive Order

ANDA Refuse-To-Receive Standards Further Illuminated By FDA In Manual of Policy and Procedures