Author Archives: Prevision Policy

West-Ward Clears First Step to Approved Status for Injectable Phenylephrine

By Prevision Policy | Published: 9.14.2012
9.14.2012

Ariad Ponatinib May Be Candidate For Rapid FDA Approval

By Prevision Policy | Published: 9.14.2012
9.14.2012

Cornerstone’s Lixivaptan: “Modest” Efficacy Not Enough For FDA Panel: Both Indications Rejected

By Prevision Policy | Published: 9.13.2012
9.13.2012

Pediatric Advisory Committee Reviews Labeling for Cadence’s Ofirmev to Minimize Confusion/Overdose in Children

By Prevision Policy | Published: 9.12.2012
9.12.2012

West-Ward Injectable Phenylephrine Should Clear Committee But Faces Uphill Fight For Broad Indication

By Prevision Policy | Published: 9.11.2012
9.11.2012

Cornerstone’s Lixivaptan Advisory Committee Preview: Dual Indications Sought, Only One Has A Chance

By Prevision Policy | Published: 9.11.2012
9.11.2012

The User’s Guide to PDUFA V (PDF Attached)

By Prevision Policy | Published: 9.07.2012
9.07.2012

GDUFA and BSUFA: Congressional Appropriations Must Kick In For Programs To Start

By Prevision Policy | Published: 9.06.2012
9.06.2012

Novartis Tobi Inhaler Wins Advisory Committee Support; Skeptical FDA Review Still An Issue

By Prevision Policy | Published: 9.05.2012
9.05.2012

Pediatric Provisions in FDASIA Maintain and Add Incentives, But More Requirements and Timelines Too

By Prevision Policy | Published: 9.04.2012
9.04.2012

Split Up HHS? As 2014 Approaches, HHS May Be Too Big To Manage

By Prevision Policy | Published: 9.01.2012
9.01.2012

FDA and AIDS: An Overview — Slide Presentation

By Prevision Policy | Published: 9.01.2012
9.01.2012

Novartis Tobi Powder Inhaler Faces Skeptical FDA Review At Upcoming Advisory Committee Review

By Prevision Policy | Published: 8.31.2012
8.31.2012

Advisory Committee Tracker: Rare Disease Applications Featured On FDA’s Fall Agenda

By Prevision Policy | Published: 8.30.2012
8.30.2012

Teva’s Neupogen-like Product Approved By FDA Goes Through Full BLA, Not Biosimilar Route

By Prevision Policy | Published: 8.30.2012
8.30.2012

FDA Advisory Committee Votes for Approval of Abbott’s Humira for Ulcerative Colitis

By Prevision Policy | Published: 8.28.2012
8.28.2012

CMS MEDCAC To Reconsider Coverage of Alzheimer’s PET Tracing Agents

By Prevision Policy | Published: 8.27.2012
8.27.2012

AIDS Drug Assistance Programs and Health Care Reform: 2013 Will be a Critical Year

By Prevision Policy | Published: 8.27.2012
8.27.2012

Abbott’s Humira for Ulcerative Colitis: Additional Trials Pre-Approval a Possibility

By Prevision Policy | Published: 8.24.2012
8.24.2012

FDA Publishes Details on Withdrawing Generic Backlog Applications, Two GDUFA Guidance Documents

By Prevision Policy | Published: 8.22.2012
8.22.2012

Get Ready for GDUFA: The New Rules for Generic Drug Reviews

By Prevision Policy | Published: 8.21.2012
8.21.2012

PDUFA V: Holding the Line on Fees

By Prevision Policy | Published: 8.20.2012
8.20.2012

Biosimilars User Fee Act: Up-Front Cost To Sponsors Will Be $200,000 Per IND In FY 2013

By Prevision Policy | Published: 8.16.2012
8.16.2012

FDA Inspection Resources and Authority Enhanced By FDASIA

By Prevision Policy | Published: 8.14.2012
8.14.2012

GW Obesity Outcomes Paper Points To New Ways To Prove Efficacy; Model For Patient-Centered Regulatory Efforts At FDA

By Prevision Policy | Published: 8.14.2012
8.14.2012

Biosimilars Update: Early Analytics the Focus at FDA Pharmaceutical Science Advisory Committee Meeting

By Prevision Policy | Published: 8.09.2012
8.09.2012

Qsymia Certified Pharmacy Network Adds Protections Against Generic Regimens

By Prevision Policy | Published: 8.08.2012
8.08.2012

REMS in FDASIA: Making Modifications Less Burdensome for Sponsors and REMS Less Burdensome for the Delivery System

By Prevision Policy | Published: 7.31.2012
7.31.2012

Senate Hearing On Gray Market Shows Issues Aren’t Black-and-White; Continues Momentum for Track-and-Trace

By Prevision Policy | Published: 7.27.2012
7.27.2012

Advisory Committee Votes In Favor of ThromboGenics’ Jetrea for VMA

By Prevision Policy | Published: 7.27.2012
7.27.2012

Genentech Lucentis Diabetic Macular Edema Use Headed for Approval: Packaging For Doses, Indications May Delay Action

By Prevision Policy | Published: 7.27.2012
7.27.2012

Advisory Committee Tracker: New Panels Focus On Old Therapies; August Review Deadlines Include Pfizer Blockbuster

By Prevision Policy | Published: 7.25.2012
7.25.2012

Jetrea for VMA: FDA Advisory Committee Asked to Discuss Breadth of Indication, Need for Additional Safety Studies Pre-Approval

By Prevision Policy | Published: 7.24.2012
7.24.2012

Progression Free Survival Trials Would Be Simplified by Audit Proposal; FDA Oncology Committee Endorses Change

By Prevision Policy | Published: 7.24.2012
7.24.2012

FDA Questions to Ophthalmic Committee on Genentech’s Lucentis DME Indication Focus on Dose: Genentech Urges Lower Dose (0.3 mg Monthly)

By Prevision Policy | Published: 7.24.2012
7.24.2012

Engineering Compliance: GSK Corporate Integrity Agreement Demonstrates Org Chart Approach to Government Control of Research Activities

By Prevision Policy | Published: 7.24.2012
7.24.2012

FDASIA Gives FDA Long To-Do List; Limited Flexibility To Initiate Policy

By Prevision Policy | Published: 7.23.2012
7.23.2012

FDASIA Adds Special Provisions for Rare Disease Applications; Pediatric Voucher Program Worth Watching

By Prevision Policy | Published: 7.20.2012
7.20.2012

Controlled Substances in FDASIA: Hydrocodone Section Shows Continued Pressure On FDA—But Not Mandates For Change

By Prevision Policy | Published: 7.19.2012
7.19.2012

Accelerated Approval Changes in FDASIA: Congress Gives Guidance, But Substance Awaits New Regulation

By Prevision Policy | Published: 7.18.2012
7.18.2012

FDA Recruits Pulmonary/Immunology Specialist from Brand Sector to Head Office of Generic Drugs

By Prevision Policy | Published: 7.16.2012
7.16.2012

FDA GAINs New Authority Over Exclusivity Awards In FDASIA Antibiotic Incentive Provisions

By Prevision Policy | Published: 7.13.2012
7.13.2012

“Breakthrough Therapy” Designation: A New Feature With Uncertain Value

By Prevision Policy | Published: 7.12.2012
7.12.2012

340B Coalition Annual Meeting Update: The Brakes Are On

By Prevision Policy | Published: 7.11.2012
7.11.2012

Extended-Release Long-Acting Opioid REMS Approved; No Substantive Changes

By Prevision Policy | Published: 7.09.2012
7.09.2012

The ABC’s of Special Status: An Alphabetical Listing of Special Designations Available to Drug Sponsors

By Prevision Policy | Published: 7.06.2012
7.06.2012

Advisory Committee Tracker: FDA Adds E&M Dates to Fall Agenda; Will ODAC Be Busy Too?

By Prevision Policy | Published: 7.05.2012
7.05.2012

Drug Shortage Provisions in FDASIA: Manufacturer Obligations Increase; GAO Study Will Set Up Future Provisions

By Prevision Policy | Published: 7.03.2012
7.03.2012

Drug Review Dossier: cysteamine bitartrate

By Prevision Policy | Published: 6.30.2012
6.30.2012

Drug Review Dossier: cobicistat

By Prevision Policy | Published: 6.30.2012
6.30.2012

  • Member Sign In:

  • Research Notes

    • No categories

  • Regulatory Tracking

    • No categories

  • All Research