Prevision Policy Clips | Generic-Delay Tactics: FDA Updates Citizen Petition Draft Guidance

Charcot-Marie-Tooth Disease Future Therapies Should Help Improve Mobility And Reduce Falls; Lead Candidate Is In Phase 3

Center Directors Panel: CDER's Woodcock, OCE's Pazdur, CBER's Marks At The Biopharma Congress Nov. 14

Prevision Policy Clips | Drug Labeling Bill Introduced in Senate

FDA Adapting To Adaptive Trials: New Draft Guidance Treats Concept As Proven, Useful Tool – But Cautions Sponsors Not To Rely On SPA Process For Complex Designs

Master Protocols Draft Guidance: FDA Provides Advice For Dealing With Frequent Changes That Occur With Target Cancers, Compounds And Combinations

Advisory Committee Tracker: Raising The Dead? Zelnorm Relaunch, Rethinking Diabetes Standards, NDAs Seeking To Recover From CRLs

Prevision Policy Clips | FDA Issues Draft Guidances On Adaptive Trials And Master Protocols

Pain Management Task Force Likely To Recommend Disease Management Approach For Chronic Pain; Cardiac Rehabilitation, Diabetes Are Models

Prevision Policy Clips | Epidiolex Cannabidiol Placed in Schedule V

FDA Authority Expands In Opioid Omnibus: Final Bill Means Opioid Rx Will Keep Dropping; Anti-Addiction And Non-Opioid Pain Drugs Encouraged, But Less Directly

Prevision Policy Clips | Final Opioid Bill Released

End The Biosimilar “Fake News”: Execs Call On FDA To Exert Regulatory Muscle Against Misleading Comments From Innovators

Opioid Use Disorder: Limits On Number Of Patients A Physician Can Treat Are Not Primary Barrier To Treatment, Duke Meeting Told; More Work Needed On Outcomes

FDA Rising Stars Panel To Feature OCE's McKee, OND's Smith At Biopharma Congress

Prevision Policy Clips | FDA Confirms Sage Postpartum Depression NDA Advisory Committee Date But Invites Drug Safety

FDA’s Value Proposition: New Drug Reviews Rely On “Accountability, Communication & Consistency;” Updated Good Review Management Guidance Avoids Nuts and Bolts

Pfizer Staph Vaccine Makes Another Appearance At DC Policy Event: CBER Official Says Basic Science Issues To Overcome

FDA ClinicalTrials.Gov Enforcement Policy: Manufacturers Will Receive Two Notices Before Fines Considered

Prevision Policy Clips | FDA’s Updated Good Review Management Practices Guidance

OMB Top Health Budget Official Grogan Nearing Shelf-Life Date; Safe Harbor Rule, Part D Modernization Have High-Level Attention

Prevision Policy Clips | FDA Nuplazid Safety Review of Postmarketing Reports “Does Not Identify Any New Or Unexpected Safety Risks”

FDA Encouraging Early Sponsor/Payor Communication; CDRH Program Has Slow Start, But Expansion Could Spark More Interest

Prevision Policy Clips | CREATES Scored Savings Increases To $3.9 Bil

Chemotherapy Hearing Loss Patient Meeting Reinforces FDA Interest In Otoprotectant Drugs, Strategies; PFDD Forum Has Seven Industry Sponsors