Regulatory Focus™ > News Articles > Regulatory Recon: FDA Approves Second Ever Opioid for Use in Children (17 August 2015)

Regulatory Recon: FDA Approves Second Ever Opioid for Use in Children (17 August 2015)

Posted 17 August 2015 | By Michael Mezher 

Regulatory Recon: FDA Approves Second Ever Opioid for Use in Children (17 August 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher and @RAPSorg on Twitter.

In Focus: US

In Focus: International

  • Will New Danish Medicines Agency Deliver Better Post-Market Service? (Clinca-$)
  • EC Releases Draft Regulation on Drug Packaging Authentication Features (EC) (Securing Industry)
  • India, EU working to end trade huff over generic drugs (Reuters) (Economic Times)
  • TPP leak: Sweeping IP protections will block biosimilars, MSF says (BioPharma-Reporter)
  • MHRA to launch pilot inspections of contract pharmacovigilance service providers (Outsourcing-Pharma) (Focus)
  • China Clarifies Medical Device Software Registration Issues (Clinica-$)

US: Pharmaceuticals and Biotechnology

  • FDA Prepares For LPAD: Orphan Drug Approvals Are Model (RPM Report)
  • Draft Guidance: Rare Diseases: Common Issues in Drug Development (FDA) (BioCentury) (Pink Sheet-$) (SCRIP-$)
  • FDA and NORD to Develop Disease Natural History Database (FDA)
  • PCSK9 Sponsors May See Opportunity In Off-Label Promotion Court Case (Pink Sheet-$)
  • FDA's Caronia Strategy Hampers Its Tactics In Amarin Court Case (Pink Sheet-$)
  • Off-Label Promotion Ruling Increases Pressure For FDA Policy Change (Gray Sheet-$)
  • Fights Over Interpretation Of Biosimilars Law: Disruption To Market's Future? (SCRIP-$)
  • FDA Approves OxyContin for Kids as Young as 11 (WSJ) (Reuters) (FiercePharma)
  • Neurology And Pain Products Keep FDA Occupied (Pink Sheet-$)
  • Drug execs pushing female libido pill have run afoul of FDA (CBS News) (PharmPro)
  • FDA Used Regulatory Loophole To Save Novartis' Farydak (Pink Sheet-$)
  • Farydak Clinical Development Timeline (Pink Sheet-$)
  • Antibiotic Injectable Coming Off FDA Shortage List (MPR)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

  • New data show Spiolto® Respimat® provides meaningful quality of life improvements in COPD (Press)
  • Pivotal Phase II study showed Roche's investigational immunotherapy atezolizumab shrank tumours in people with a specific type of lung cancer (Press)
  • B-YOND Extension Study Reinforce LongK-Term Clinical Profile of ALPROLIX for the Treatment of Hemophilia B (Press)
  • Veloxis Pharmaceuticals: Envarsus XR granted Orphan Drug status in the US (Reuters)
  • Spectrum Pharmaceuticals Announces Agreement with FDA on the Special Protocol Assessment (SPA) for the Upcoming Apaziquone Phase 3 Trial (Press)
  • Teva Announces FDA Acceptance of NDA for SD-809 for Huntington Disease Treatment (DD&D)
  • Clinical Data From Merz Neurosciences’ Phase III Study of Xeomin (Incobotulinumtoxina) for Spasticity to Be Published in “Muscle & Nerve” (Press)
  • Baxter and Water Street Announce FDA Approval of Cefazolin 2 Gram Premix (Press)
  • Avalanche hits the brakes on its gene therapy program after a Phase II misstep (FierceBiotech)

US: Pharmaceuticals and Biotechnology: General

  • Draft Guidance:  Qualification of Biomarker-Total Kidney Volume in Studies for Treatment of Autosomal Dominant Polycystic Kidney Disease (FDA) (BioCentury)
  • Guidance: Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices (FDA)
  • Draft Guidance: Botanical Drug Development (FDA)

US: Medical Devices

  • Hospira: BlackBerry infusion pump ‘hack’ video was a sham (MedCityNews)
  • GE Healthcare First to Receive FDA Clearance for Low Dose CT Lung Cancer Screening (Press)
  • Next up for Google: a glucose-sensing patch for diabetics (mHealthNews)
  • Yale Study: More Testing Of High-Risk Med Devices Needed (MedDeviceOnline)
  • FDA releases draft guidance on the request for quality metrics (MassDevice) (Focus)
  • Google Glass Shown Beneficial for Bedside Toxicology Consults (medGadget)
  • The Importance of Intellectual Property in the Device Lifecycle (MDDI)
  • Electronic Medical Device Reporting Is Now Mandatory – Is Your Firm Ready? (Gray Sheet-$)
  • NOWDiagnostics gets FDA blessing for one-step pregnancy test (FierceMedicalDevices)
  • FDA Touts Faster Med Device Approval Times (MedDeviceOnline) (FierceMedicalDevices)
  • FAU neuroscientist develops new, rapid dementia screening tool that rivals 'gold standard' clinical evaluations (MNT)
  • Computerized Cognitive Assessment Aid Reclassified to Class II (FDA)
  • Class 1 Device Recall Puritan Bennett 980 Ventilator System Universal and Neonatal Models (FDA)
  • Class 1 Device Recall PS500 of an IACS Workstation Critical Care (Evita Infinity V500) (FDA)
  • Class 1 Device Recall Alaris Syringe Pump, Model No. 8110 (FDA)
  • FDA Approves Orbera Bariatric System (Press)
  • A Crash Course In Choosing Biocompatible Wearable Tech Materials (MedDeviceOnline 1, 2)

US: Assorted and Government

  • Carly Fiorina: "Always the parent's choice" to vaccinate kids (CBS News)
  • Carly Fiorina Is Against Vaccine Mandates But She's For Them But Also Against Them (Forbes)
  • Valeant Latest Congressional Target Over High Drug Prices (SCRIP-$)

Upcoming Meetings and Events              

Europe

  • India, EU working to end trade huff over generic drugs (Reuters) (Economic Times)
  • Essex man jailed for playing key role in illegal pharmacy business (MHRA)
  • Will New Danish Medicines Agency Deliver Better Post-Market Service? (Clinca-$)
  • EC Releases Draft Regulation on Drug Packaging Authentication Features (EC) (Securing Industry)
  • MHRA to launch pilot inspections of contract pharmacovigilance service providers (Outsourcing-Pharma) (Focus)
  • EU's IMI research world class, report reveals (PharmaLetter-$)
  • NICE plots takeover of England's Cancer Drugs Fund (FiercePharma)

China

  • China Clarifies Medical Device Software Registration Issues (Clinica-$)

India

Japan

  • PMDA Warns of Eye Infections From Colored Contact Lenses (Japan Times)

Ebola Outbreak

Other International                                               

General Health and Other Interesting Articles                                                           

  • Legionella and Waterborne Outbreaks are Increasing, Warns CDC (Forbes)

Regulatory Reconnaissance #619 – 17 August 2015

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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