Prevision Policy Clips | CMS Mystery Reg Explained?

340B Pricing Rule Effective Date Would Move Up To Jan. 1 Under Pending HHS Proposal; “Penny Pricing” Likely To Be Implemented—But April 1 May Be Compromise

Prevision Policy Clips | Naloxone Co-Prescribing With Opioids Will Be Subject Of FDA Advisory Committee

Prevision Policy Clips | FDA Signals Openness To Moving On From CV Outcomes Trials For Diabetes Drugs

XLH Patient Meeting Showcases Ultragenyx Crysvita And Demonstrates Value Of PFDD Events After A Major Advance

Prevision Policy Clips | Rogue Advisory Committee Chair Urges FDA to Reject AcelRx Dsuvia

CMS Administrator Highlights Value-Based Models For New Drugs In Medicare, Changes To Protected Classes As Near-Term Priorities

Shire’s Prucalopride Joins 5HT4-Agonist Revival; Committee Supports Approval For Constipation Based On “Real World” Safety In Europe

Zelnorm Is An IBS-Comeback Kid: Re-Intro Expected After Positive Committee Vote; Definition Of Patients At “Low CV Risk” To Be Determined By FDA

Prevision Policy Clips | Register now for the Biopharma Congress on Nov. 14 in Washington, DC

FDA’s Woodcock Plays Defense On Approval Standards: Drug Pricing Debate Has Role In Public Perception Of Lowered Bar For Approval

FDA Regulatory Agenda Includes Finalizing 2010 DTC “Major Statement” Rule; Likely To Have More Impact Than Price Disclosure Proposal

Prevision Policy Clips | HHS Rebate Rule Expected In October, According To Fall Regulatory Agenda

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"