Regulatory Policy

Lotronex REMS Set For July Committee Review; Another Touchstone in REMS Reconsideration—And Revival of IBS Class

By Prevision Policy | Published: 5.22.2013
5.22.2013

Pharmacy Compounding Bill Moves To Senate Floor, But Avastin Status May Change; House Action Still Uncertain

By Prevision Policy | Published: 5.22.2013
5.22.2013

Track and Trace Bill Moves To Senate Floor, But Folded Into Compounding Bill; Tie Likely to Complicate Passage

By Prevision Policy | Published: 5.22.2013
5.22.2013

FDA REMS Meeting Set For July; Near Term Focus On Nuts & Bolts; Long-Term Implications For Alternative Approval Models

By Prevision Policy | Published: 5.21.2013
5.21.2013

Merck’s Suvorexant Starting Dose Is Unresolved Question for Sleep Agent: FDA Asks Committee If Further Study of Lower Doses is Appropriate

By Prevision Policy | Published: 5.20.2013
5.20.2013

Track and Trace Bill Passes Energy & Commerce; Defeated Amendments Keep It Moving, But Remain Issues for Conference

By Prevision Policy | Published: 5.15.2013
5.15.2013

FDA’s HIV Patient-Input Meeting on June 14: Focus Will Be Untreated Symptoms and Cure Research

By Prevision Policy | Published: 5.14.2013
5.14.2013

Endo Opana ER Generics Remain: FDA Doubts Abuse-Deterrence of Formulation; Endo Postmarket Data is Immature, More Time May Help

By Prevision Policy | Published: 5.10.2013
5.10.2013

Pharmacy Compounding: Senate Draft Getting Closer to Markup, But Issues Divide Stakeholders in Hearing

By Prevision Policy | Published: 5.09.2013
5.09.2013

FDA Expanded Access Q&A Highlights Emerging Theme of Patient Feedback Era; Will Advocates Push Pharma To Do More?

By Prevision Policy | Published: 5.09.2013
5.09.2013

ADUFA and Track and Trace Clear House Subcommittee; Bills on Parallel—but Still Separate—Tracks

By Prevision Policy | Published: 5.08.2013
5.08.2013

Arena’s Belviq Finally Gets DEA Scheduling; Lag-Time Has Implications for Merck’s Suvorexant

By Prevision Policy | Published: 5.07.2013
5.07.2013

House Track and Trace Bill Would Push Unit Tracking To 2027; Moves Other Pedigree Deadlines Forward

By Prevision Policy | Published: 5.06.2013
5.06.2013

Delcath Melblez Rejected By FDA Advisory Committee; New Study With Improved Device Needs To Show Less Toxicity

By Prevision Policy | Published: 5.02.2013
5.02.2013

CFS/ME Patient Input Meeting Will Jumpstart FDA Guidance Effort

By Prevision Policy | Published: 5.02.2013
5.02.2013

Aveo’s Tivozanib: FDA Advisory Committee Is Over Before It Starts As Negative Survival Trend Trumps All

By Prevision Policy | Published: 5.02.2013
5.02.2013

HHS’ Howard Becomes Deputy at FDA; Personnel Changes Cement Close Ties Between FDA and HHS Leadership

By Prevision Policy | Published: 4.30.2013
4.30.2013

Aveo’s Tivozanib for Advanced Renal Cell Carcinoma: Negative Survival Trend Likely Too Much To Overcome At ODAC

By Prevision Policy | Published: 4.30.2013
4.30.2013

Delcath Melblez Appears Headed To “No” Vote at FDA Panel; New Study Likely Needed to Validate Device, Confirm Benefit

By Prevision Policy | Published: 4.30.2013
4.30.2013

FDA Appropriations Hearing Features Calls to Undo User Fee Sequestration; Compounding, Abuse Continue to Be Key

By Prevision Policy | Published: 4.29.2013
4.29.2013

FDA Patient Input Inaugural Meeting Performs Best on Symptom Collection in CFS/ME

By Prevision Policy | Published: 4.26.2013
4.26.2013

Senate Compounding Draft Includes User Fees; Sponsors Tout “Bright Line” Definition of “Compounding Manufacturer”

By Prevision Policy | Published: 4.26.2013
4.26.2013

E&C Track and Trace Hearing: Support for Adding Timeline for Unit-Level System to House Discussion Draft

By Prevision Policy | Published: 4.25.2013
4.25.2013

Track and Trace Draft Legislation Released Ahead of Thursday House Hearing; Senate Bill Requires Eventual Unit-Level Tracing

By Prevision Policy | Published: 4.24.2013
4.24.2013

Senate Appropriations Hearing: FDA Fields Questions on Compounding, Sequestration Impact on User Fees

By Prevision Policy | Published: 4.18.2013
4.18.2013

Endo Long-Acting Testosterone NDA Headed to Third FDA Rejection After Negative Panel Vote

By Prevision Policy | Published: 4.18.2013
4.18.2013

GSK’s Breo COPD Exacerbation Benefit Outweighs Pneumonia Risk in Key Votes for Approval by FDA Committee

By Prevision Policy | Published: 4.17.2013
4.17.2013

Part D Rebates Bill Brings Doc Fix Risk to Biopharma Though Odds of Enactment Still Low

By Prevision Policy | Published: 4.17.2013
4.17.2013

FDA Denies OxyContin Generics: First “Abuse-Deterrent” Claim Given To Purdue Brand; Endo Opana ER Decision Still Pending

By Prevision Policy | Published: 4.16.2013
4.16.2013

Compound Fracture: House GOP Attacks Will Slow Compounding Legislation; May Increase FDA Compliance Activities Across-the-Board

By Prevision Policy | Published: 4.16.2013
4.16.2013

Endo Long-Acting Testosterone NDA is Long Shot at Advisory Committee; Reformulation Likely Necessary

By Prevision Policy | Published: 4.16.2013
4.16.2013

GSK/Theravance Step-Skipping Development Program for Breo Is Issue for April 17 FDA Committee; Efficacy Data on Combo vs. LABA Single-Ingredient is “Not Entirely Consistent,” FDA Says

By Prevision Policy | Published: 4.15.2013
4.15.2013

FDA To Hold HIV and Lung Cancer Patient-Input Meetings in June; Full List for 2013-2015 Published

By Prevision Policy | Published: 4.11.2013
4.11.2013

FDA Budget Request Underscores GDUFA Impact: Foreign Inspections To Increase; Generic Reviews Have More Resources

By Prevision Policy | Published: 4.10.2013
4.10.2013

Rx Compounding Legislation: Pressure Continues, But Enactment More Likely in 2017 Than 2013

By Prevision Policy | Published: 4.10.2013
4.10.2013

House Animal Drug User Fee Act Hearing Focuses on Agricultural Antibiotic Use; No Mention of Rx Supply Chain or Compounding

By Prevision Policy | Published: 4.10.2013
4.10.2013

Politics in Plan B Ruling Overshadow Implications for FDA’s New Nonprescription Switch Paradigm

By Prevision Policy | Published: 4.05.2013
4.05.2013

“Breakthrough” Discussion Between Ariad and FDA Underscores Policy of Multiple Designations for a Single Indication

By Prevision Policy | Published: 4.05.2013
4.05.2013

FDA’s Bob Temple Explains Accelerated Approval In Context of Broad Range of Special Tools to Expedite Development and Approval Processes: Webinar with Duchenne Patient Advocates

By Prevision Policy | Published: 4.03.2013
4.03.2013

Biosimilars Meetings Guidance: Another Sign of Slow Start for Biosimilars But Reaffirms FDA’s Commitment to Get Sponsors onto New Pathway

By Prevision Policy | Published: 4.01.2013
4.01.2013

FDA on Alzheimer’s Guidance: Focus Is on Early Disease, Not “Loosening” Guidelines

By Prevision Policy | Published: 4.01.2013
4.01.2013

Controlled Substances Update: Abuse-Deterrent Labeling Guidance Moving Forward; FDA and DEA at Odds on Key Topics

By Prevision Policy | Published: 3.29.2013
3.29.2013

Mobile Apps in GOP Oversight Spotlight: Hearings Offer Template for Future Rx Focused Issues; Minimal Impact on FDA Policy

By Prevision Policy | Published: 3.22.2013
3.22.2013

Titan’s Probuphine: FDA Advisory Committee Supports Approval; Timing Depends on Addressing REMS Concerns

By Prevision Policy | Published: 3.22.2013
3.22.2013

Off-Label Communication Makes Short List for House Oversight of FDA in 2013; Hearings May Encourage FDA Policy Clarification

By Prevision Policy | Published: 3.21.2013
3.21.2013

Animal Drug User Fee Bill Clears Senate Committee; No Amendments Added

By Prevision Policy | Published: 3.20.2013
3.20.2013

GSK/Theravance Breo Committee Review Rescheduled For April 17; Delay Past May Review Deadline Looking Likely

By Prevision Policy | Published: 3.20.2013
3.20.2013

Generic Drugs Office Interim Head Uhl Brings Management, Policy Background

By Prevision Policy | Published: 3.19.2013
3.19.2013

Titan’s Opioid Dependence Implant Probuphine: FDA Focused on Surgical Training and Safety, Dosing, and REMS

By Prevision Policy | Published: 3.19.2013
3.19.2013

Generic Injectables — Slide Presentation

By Prevision Policy | Published: 3.15.2013
3.15.2013

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