Aerie Rhopressa Glaucoma Therapy Breezes Through Committee; Broad Indication Likely, Side Effect Labeling May Need Attention

Spark’s Luxturna Gene Therapy Review Shows Good Signs For Next Gene Therapies; Good Base For Commercialization

Prevision Policy Clips | White House Actions on Affordable Care Act

Prevision Policy Clips | “Determining Whether to Submit an ANDA or a 505(b)(2) Application” Draft Guidance Available

340B Providers Push Back In House Hearing; Investigation On Use Of Discount Turns On Pharma

Aerie Rhopressa On Track For Approval In Glaucoma; FDA Review Finds Less Efficacy Than Timolol In Some Patients, But Not Major Issue For Label

Prevision Policy Clips | Eric Hargan Named Acting HHS Secretary

Spark Luxturna Gene Therapy: FDA Wants Public Discussion of Novel Endpoint, Voices Some Discontent Over Clinical Meaningfulness

Prevision Policy Clips | California Drug Pricing Transparency Bill Enacted

FAERS Or Foul? New Dashboard Is Sign Of Strength In FDA Regulatory Climate – But A Complication For Drug Sponsors

HHS Secretary Shortlist May Have McClellan And A Governor Up Top; Verma And Gottlieb Are Long Shots

Prevision Policy Clips | Rx Drug Pricing Senate HELP Hearing To Feature Industry Trade Groups

Patient-Focused Drug Development Next Steps: Guidance to Get to Usable Data, More Externally-Led Meetings

FDA Tracking Potential Supply Shortages In Puerto Rico; “Public Health Priority” With 13 Sole-Source Drugs At Risk

FDA Plans New Guidance On Addiction Therapy; Commissioner Gottlieb Wants “Sustained” Decline In Opioid Prescribing

Prevision Policy Clips | 340B Drug Pricing Program hearing to be held by Energy & Commerce Subcommittee on Oversight October 11

Prevision Policy Clips | Allergan’s Restasis Patent Deal With Saint Regis Mohawk Tribe Draws Bipartisan House Oversight Letter

“Right To Try” Bill Needs Tweaks Before Passage, FDA’s Gottlieb Says; Improvements To Expanded Access A Better Option

HHS Shakeup: FDA and CMS Get More Independent As Department Enters Caretaker Status

Lab-Developed Test Oversight Is Coming: FDA Will Provide “Regulatory Touch” While Awaiting Comprehensive Legislation From Congress

FDA Complex Generic Regulatory Improvements: GDUFA Sponsor Meeting Rules Proposed; ANDA Route Explained For Five Peptides

Prevision Policy Clips | CMS Notice Confirms Withdrawal of Part B Demo

Pain Drug Policy: Small Carrots For Innovators, Big Sticks To Curb Opioid Use Discussed At Presidential Commission

Prevision Policy Clips | Novo Nordisk’s semaglutide for diabetes, two buprenorphine injection opioid dependence therapies set for advisory committee reviews

FDA Advisory Committee Tracker: Upcoming Topics Focus On Trial Designs For Staph Aureus Vaccine, Bladder Pain Therapy