Regulatory Focus™ > News Articles > Regulatory Recon: Amarin Commentary, Lessons From FDA's Infusion Pump Hacking Warning and More! (11

Regulatory Recon: Amarin Commentary, Lessons From FDA's Infusion Pump Hacking Warning and More! (11 August 2015)

Posted 11 August 2015 | By Michael Mezher 

Regulatory Recon: Amarin Commentary, Lessons From FDA's Infusion Pump Hacking Warning and More! (11 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

  • Survey finds many women anticipating approval of new libido prescription (DSN)
  • A Look at FDA’s Rationale for Granting – and the Scope of – Exclusivity for Abuse-Deterrent Oxycontin (FDA Law Blog)
  • Amarin case could unleash a flood of off-label promos (FiercePharmaManufacturing) (Focus)
  • Single-Arm Studies Can Have Adaptive Designs, Industry Tells FDA (Gray Sheet-$)
  • Hundreds of Women Petition FDA on Essure (MDDI)
  • Amarin's Off-Label Victory Opens Door To More Injury Claims (Law360-$)
  • Once Disparaged, 'Me-Too' Drugs Crucial For Lower Costs Of Cholesterol, Hepatitis C And Cancer Drugs (Forbes)
  • Quality Metrics May Reduce FDA Inspections For Pharma Cos. (Law360-$) (Focus)
  • Podcast: FDA To Launch New Knowledge-Sharing Platform For Next-Gen Sequencing (Pink Sheet-$) (Focus)
  • 4 Lessons From The FDA's Milestone Device-Hacking Alert (Law360-$)
  • Study: Breakthrough med devices slower to market than blockbuster drugs (MassDevice)
  • How easy is it to hack an infusion pump? Watch this video (MedCityNews)

In Focus: International

  • Making IT services for medicine regulation in Europe more efficient (EMA)
  • New and Revised EMA Pharmacovigilance Guidelines (EMA 1, 2, 3, 4)
  • Rise in medical radiation incidents (OnMedica)
  • Indian CRO hit with FDA warning letter over two specific violations (Outsourcing-Pharma)
  • Indian pharma’s quality-regulatory challenges attributed to behavioural concerns over technical issues: SM Mudda (PharmaBiz)
  • New Medical Device Software Guidance from Chinese FDA (MassDevice) (FiercePharmaAsia)
  • One Man's Quest To Combat Counterfeit Drugs — With A Suitcase (NPR)    

US: Pharmaceuticals and Biotechnology

  • A Look at FDA’s Rationale for Granting – and the Scope of – Exclusivity for Abuse-Deterrent Oxycontin (FDA Law Blog)
  • Amarin case could unleash a flood of off-label promos (FiercePharmaManufacturing) (Focus)
  • Single-Arm Studies Can Have Adaptive Designs, Industry Tells FDA (Gray Sheet-$)
  • Hundreds of Women Petition FDA on Essure (MDDI)
  • Amarin's Off-Label Victory Opens Door To More Injury Claims (Law360-$)
  • Once Disparaged, 'Me-Too' Drugs Crucial For Lower Costs Of Cholesterol, Hepatitis C And Cancer Drugs (Forbes)
  • C-Path Consortium Aims To Speed, De-Risk Duchenne R&D (SCRIP-$)
  • Changing Face: A Review of the Regulatory History of Azelaic Acid and the Changing Requirements at FDA (The 505(b)(2) Blog)
  • Battle Over Who Gets $15,000 Heart Drug Focuses on Guidelines (Bloomberg) (Reuters)
  • Researchers Develop a Better Flu Vaccine (ICT)
  • Survey finds many women anticipating approval of new libido prescription (DSN)
  • Novavax hopes to crack elusive vaccine for common respiratory virus (Reuters)

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

  • Orexo: U.S. FDA Approves ZUBSOLV® for Induction of Buprenorphine Maintenance Therapy in Patients Suffering from Opioid Dependence (Press)
  • Recombinant IVIG granted Orphan Drug Designation for CIDP (MPR)
  • U.S. Army and Helius Medical Technologies Announce Launch of Phase 3 Traumatic Brain Injury Clinical Trial (Press)
  • Immune Design and Merck to test Keytruda combinations for non-Hodgkin's lymphoma and melanoma (PharmaLetter-$)
  • FDA to review Takeda's depression drug (BioSpectrum) (Press)
  • Taro’s Keveyis gets FDA approval (DSN)
  • Upsher-Smith gets FDA OK on Namenda generic (DSN)

US: Pharmaceuticals and Biotechnology: General

  • Visual Podcast: FDA & Complaints – Your Achilles Heel (Gray Sheet-$)
  • How does personalized medicine fit into the future of healthcare? (MedCityNews)
  • Quality Metrics May Reduce FDA Inspections For Pharma Cos. (Law360-$) (Focus)
  • Podcast: FDA To Launch New Knowledge-Sharing Platform For Next-Gen Sequencing (Pink Sheet-$) (Focus)
  • What is Compounding? (USP Quality Matters)
  • Edible tags can authenticate pharmaceutical products (Securing Industry)

US: Medical Devices

  • 4 Lessons From The FDA's Milestone Device-Hacking Alert (Law360-$)
  • Study: Breakthrough med devices slower to market than blockbuster drugs (MassDevice)
  • How easy is it to hack an infusion pump? Watch this video (MedCityNews)
  • VisionGate sets sights on FDA approval for noninvasive lung cancer Dx (FierceDiagnostics)
  • FDA approves tool for diagnosing dementia in a doctor’s office (Washington Post)
  • Study examines high-risk therapeutic medical devices receiving FDA premarket approval (MedicalXpress)
  • What Are Antimicrobial Materials For Plastic Injection Molding? (MedDeviceOnline)
  • Understanding the Types Of Sterilization For Medical Device Components (MedDeviceOnline)
  • Flowonix wins FDA nod for drug pump (MassDevice)

US: Assorted and Government

  • A debate over U.S. pharmaceuticals is snagging the Trans-Pacific Partnership deal (Washington Post) (WSJ)
  • Bill introduced to fix FDA's combination product regs; attorneys say it doesn't go far enough (FierceMedicalDevices)
  • Novartis' Dementia Patch Patent Suit Gets Booted (Law360-$)
  • Lilly chalks up a win for Cymbalta in first U.S. trial over withdrawal symptom claims (FiercePharma)
  • Congress urges feds to probe FDA over morcellator safety concerns (FierceMedicalDevices)
  • House to FDA: who’s in charge of clinical trial manufacturing? (In-Pharma Technologist)
  • District Court Rules on Reporting Overpayments and False Claims Act Liability (Policy and Medicine)
  • Mass. bill would force drugmakers to defend prices (Boston Herald)

Upcoming Meetings and Events                                                            

Europe

  • Making IT services for medicine regulation in Europe more efficient (EMA)
  • New and Revised EMA Pharmacovigilance Guidelines (EMA 1, 2, 3, 4)
  • Rise in medical radiation incidents (OnMedica)
  • Three new drugs green-lighted for NHS Scotland (PharmaTimes)

Canada

  • Glaukos iStent wins nod from Health Canada (MassDevice)
  • Canadian pharmacy sold unapproved and counterfeit drugs online, US alleges (The Guardian)

India

  • Indian CRO hit with FDA warning letter over two specific violations (Outsourcing-Pharma)
  • Indian pharma’s quality-regulatory challenges attributed to behavioural concerns over technical issues: SM Mudda (PharmaBiz)
  • Katoch panel moots mega parks for bulk drug manufacturing (Economic Times)

China

Other International

  • Thailand's state-run drugmaker objects to competition moves (FiercePharmaAsia)
  • One Man's Quest To Combat Counterfeit Drugs — With A Suitcase (NPR)    

General Health and Other Interesting Articles

  • The Emergent Microbiome: A Revolution for the Life Sciences – Part I, R&D Leaders (Patent Docs)
  • Is Google's Switch To Alphabet Good For Healthcare? Definitely Maybe (Forbes)
  • New CDC Video Shows How Antibiotic-Resistant Bacteria Spread Between Healthcare Facilities (ICT) (YouTube)
  • High Tech Hope for Repelling Mosquitoes (NYTimes)
  • If You Fall Ill Abroad, Should You Seek Local Help Or Head Home? (NPR)

Regulatory Reconnaissance #615 – 11 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.


Categories: Recon, Regulatory News

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