FDA Neurology Head Dunn's “Two Laws” On Novel Efficacy Approaches: “Meaningful” Changes On “Meaningful” Domains

Resurrecting Zelnorm: FDA Appears Ready For Market Re-Intro Of IBS Drug; Question Is How To Restrict Indication, Given CV Risk

Shire Motegrity Review: Committee To Weigh Unmet Need In Constipation Versus Uncertainty In CV Safety

Prevision Policy Clips | FDA Gets In On The Action With DTC Guidance On Presenting Quantitative Efficacy and Risk Data

DTC Price Disclosure: HHS Rule Relies On Private False Advertising Cases For Enforcement; PhRMA Policy Change Should Pay Dividends

AcelRx’ Dsuvia Appears Headed Toward Approval For Inpatient Acute Pain After Positive Committee Vote; “Dropped” Tablets Not a Major Concern for Panelists

Rare Disease Sponsors Advised To Plan To Randomize The First Patient In Pre-IND Meeting Guidance; FDA Rapidly Finalizes Targeted Subset Guidance From December

Prevision Policy Clips | DTC Price Disclosure Policy Announcement Today?

FDA Common Rule Guidance Allows for Single Informed Consent Form To Comply With Both HHS and FDA Regulations

Prevision Policy Clips | Register now for the Biopharma Congress on Nov. 14

Trevena’s IV Opioid Oliceridine Barely Voted Down 8-7 By FDA Panel Over Efficacy Questions In The Context Of Ongoing Public Health Crisis

Prevision Policy Clips | “We’re creating a pathway for importation of drugs"

Celltrion’s Rituximab Biosimilar Gets Unanimous Support From ODAC Eight Months After CRL

AcelRx Dsuvia Sufentanil Sublingual System Appears Ready For Approval – Assuming FDA Committee Agrees REMS And Inpatient Setting Will Minimize Abuse

Prevision Policy Clips | Register now for the Biopharma Congress on Nov. 14

The New OND Panel to Feature FDA’s Peter Stein, Merck’s Sandra Milligan, Greenleaf’s John Jenkins at Biopharma Congress

“Breakthrough” Bust: Trevena IV Oliceridine Appears Less Effective Than Morphine, May Cause QT Prolongation, FDA Tells Advisory Committee

Prevision Policy Clips | Akcea/Ionis’ Tegsedi (Inotersen) Approved

Celltrion’s Rituximab Biosimilar Headed for Clean Advisory Committee Review; Sponsor Not Seeking All Indications Due To “IP and Exclusivity Landscape”

Prevision Policy Clips | FDA Advisory Committee to Discuss Opioid-Sparing Outcomes in Acute Pain Trials

FDA Real World Evidence Demos Take On COPD, Juvenile Arthritis and Inflammatory Bowel; FDA Committed To Hands-On Learning About Registry Studies

The Next Step After “Right To Try”? Senate Hearing Includes Call To Reopen The Orphan Drug Act

Prevision Policy Clips | CMS New Technology Add-On Payment “Town Hall” Set For December 4

Prevision Policy Clips | Paratek’s Big Day: FDA Approves Antibiotic Nuzyra and Acne Treatment Seysara

FDA Defines Citizen Petition Abuse: Updated Draft Guidance Notes Corporate History Can Count Against Brand Sponsors