Lupus Patient-Focused Meeting Conveys Impact of Fatigue To FDA Neurology Staff; Woodcock Comments On Meaning of Sarepta

Opioid REMS Expansions Continues With Formal Notice To IR Firms; Tangible Progress To Highlight Alongside FDA Request For New Ideas

Prevision Policy Clips | HRSA Officially Delays 340B Ceiling Price Rule Until July 1

PTC Ataluren Needs Another Study, FDA Committee Says; Setback For One Sponsor – But Good News For Review Climate

Prevision Policy Clips | FDA Issues Guidance To Advance Novel Technology to Improve Reliability and Safety and Help Lower Cost of Manufacturing

End Of An Era: FDA-Hosted Patient-Focused Drug Development Meetings Conclude; Next Phase Of Engagement Kicks Off

Prevision Policy Clips | FDA Takes Steps to Encourage Compounders to Register as “Outsourcing Facilities”

PTC Ataluren For DMD: FDA Wants Committee Support To Request New Study – And To Get Back To Normal On Reviews

Hereditary Angioedema Patients Cite Dosing, Product Shortages As Reasons For More R&D; High Interest To Enroll In Clinical Trials

Prevision Policy Clips | FDA’s Temple To Present “Efficacy Considerations” At PTC ataluren Advisory Committee Meeting

Platform Trials Form Launch Pad For Regulatory Adoption Of Real World Evidence: FDA, Industry Ready For End Of Talking Phase?

Prevision Policy Clips | Intellipharmaceutics’ Receives Complete Response Letter For Abuse Deterrent Oxycodone ER NDA

Prevision Policy Clips |Clinical Trial Requirements, Regulations, Compliance, & Good Clinical Practice FDA Workshop

Biosimilars Statistical Guidance: No Ex-US Reference Products For Analyzing Similarity; Gottlieb Frames As “Drug Pricing” On Twitter

Antibiotic Prize Approach Endorsed In PACCARB Report; New Focus On “Pull” Incentives May Not Help Stalled Push For Legislation

Prevision Policy Clips | Biosimilars Draft Guidance: Statistical Approaches to Evaluate Analytical Similarity

CMS Seeking “Small Scale” Tests Of Alternative Drug Payment Models; Innovation Center Cleansed Of Obamacare Roots

Medicare-For-All And Drug Price Controls: Higher-Stakes Political Debate May Be Safer Ground For Biopharma Overall

Prevision Policy Clips | CMS Administrator Seema Verma Opens Process For Re-Defining Role of CMMI

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