Regulatory Focus™ > News Articles > Regulatory Recon: Taking the Big Picture View of FDA Approvals (26 June 2014)

Regulatory Recon: Taking the Big Picture View of FDA Approvals (26 June 2014)

Posted 26 June 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: Taking the Big Picture View of FDA Approvals (26 June 2014)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • A Review of Drug Development and FDA Approval, 1938–2013 ( NEJM)
  • FDA Panel Crushes AstraZeneca’s Hopes For Olaparib Accelerated Approval ( Pink Sheet-$) ( Pharma Times) ( AZ) ( Fierce) ( Reuters) ( MedPage Today) ( SCRIP-$) ( BioCentury) ( Bloomberg)
  • FDA Warns of Dangerous Side Effects from Topical Acne Products ( FDA) ( FDA) ( FDA) ( Law 360-$) ( NBC) ( Reuters) ( Tan Sheet-$)
  • FDA: Seeking Stakeholder Input In Draft Guidances Could Create Confusion ( IHP-$)
  • Non-profit group submits DMD guidance to FDA ( BioCentury)
  • Boehringer's Pradaxa antidote idarucizumab deemed 'breakthrough' by FDA ( SCRIP-$) ( Press)
  • Hospital Networks Are Leaking Data, Leaving Critical Devices Vulnerable ( Wired)
  • Analysis of FDA warning letters reveals patient safety concerns ( MNT)

In Focus: International

  • Birth defects blamed on unapproved morning sickness treatment ( The Star)
  • Dangers of off-label drug use kept secret ( The Star)
  • EU Device Regulations - What's Changing and What Will Be The Impact? ( MedDeviceSummit)
  • EU regulators approve Intuitive Surgical's next-gen da Vinci medical robot ( Mass Device) ( Press)
  • India Mulls Aid To Smaller Drug Makers To Meet Production Standards ( PharmAsia-$) ( Fierce)
  • 6 Objectives China Has Set For Itself On Pediatric Drugs ( Law 360-$)

US: Pharmaceuticals and Biotechnology

  • FDA Panel Crushes AstraZeneca’s Hopes For Olaparib Accelerated Approval ( Pink Sheet-$) ( Pharma Times) ( AZ) ( Fierce) ( Reuters) ( MedPage Today) ( SCRIP-$) ( BioCentury) ( Bloomberg)
  • A Review of Drug Development and FDA Approval, 1938–2013 ( NEJM)
  • FDA Warns of Dangerous Side Effects from Topical Acne Products ( FDA) ( FDA) ( FDA) ( Law 360-$) ( NBC) ( Reuters) ( Tan Sheet-$)
  • FDA: Seeking Stakeholder Input In Draft Guidances Could Create Confusion ( IHP-$)
  • Non-profit group submits DMD guidance to FDA ( BioCentury)
  • Two top Republicans back generic drugmakers in fight with FDA ( Reuters)
  • “I Didn’t Inhale” – But FDA’s Position on Medical Marijuana is Still Cloudy ( FDA Law Blog)
  • Mini-Sentinel to Assess Heart Attack Risk of Mirabergron ( Mini-Sentinel)
  • CBER Wants Mini-Sentinel Assessment of Prevnar 13 vaccine, Blood Products ( Mini-Sentinel)
  • AMP-lifying Collaboration ( CMM) ( BIO)
  • Michigan State Bill Would Regulate Compounding Pharmacies ( Scout)
  • Should Asthma Mediciations be Available OTC? ( PubMed)
  • The challenge of indication extrapolation for infliximab biosimilars ( PubMed)
  • Drug Challenged Under AIA Biz Method Review For 1st Time ( Law 360-$)
  • CDC committee recommends AZ's FluMist over flu shot in children ( Fierce) ( AP)
  • Actavis Files ANDA for Generic MS Drug Ampyra ( Press) ( Reuters)

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

  • Boehringer's Pradaxa antidote idarucizumab deemed 'breakthrough' by FDA  ( SCRIP-$) ( Press)
  • Eisai Anti-Seizure Fycompa Drug Clears Final Trials In EU, U.S. ( PharmAsia-$)
  • US orphan status for Insys Therapeutics’ cannabidiol for rare form of epilepsy ( Pharma Letter-$)
  • US: Pharmaceuticals and Biotechnology: General
  • Mass. Gov. Signs Biologic Substitution Bill Into Law ( Law 360-$) ( BioCentury)
  • Should Alzheimer’s Bonds be Issued to Fund Drug Development? ( Pharmalot)
  • House Lawmakers Try Again To Unbundle Bladder Cancer Drug ( IHP-$)

US: Medical Devices

  • Hospital Networks Are Leaking Data, Leaving Critical Devices Vulnerable ( Wired)
  • Nitinol Devices and Components, Inc., HydroFinity Hydrophilic Guidewire - May be Damaged during Use and May Lead to Injury ( FDA) ( FDA)
  • FUJIFILM Announces FDA 510(k) Clearance for New Breast Imaging Solution: Aspire Cristalle ( Press)
  • Paragon BioTeck, Inc. Receives FDA Clearance for Comfortear Lacrisolve Absorbable Punctum Plug ( Press)

US: Dietary Supplements

  • Pieter Cohen: Current Supplement AER System Inadequate ( NPI)
  • Consumer group wants U.S. FDA to order warning on energy drinks ( Reuters)

US: Assorted And Government

  • Analysis of FDA warning letters reveals patient safety concerns ( MNT)
  • Mini-Sentinel Launches New Website, Borrowing from FDA.gov ( Mini-Sentinel)

Europe

  • EU Device Regulations - What's Changing and What Will Be The Impact? ( MedDeviceSummit)
  • EU regulators approve Intuitive Surgical's next-gen da Vinci medical robot ( Mass Device) ( Press)
  • EMA to review Hyperion's Ravicti ( BioCentury)
  • Sobi seeks EMA approval for Xiapex for Peyronies disease ( PBR)

India

  • India Mulls Aid To Smaller Drug Makers To Meet Production Standards ( PharmAsia-$) ( Fierce)

Japan & China

  • 6 Objectives China Has Set For Itself On Pediatric Drugs ( Law 360-$)
  • Eisai Files Lenvatinib MAA in Japan ( Press)
  • Baxter Japan Gets Regular Administration Of Feiba Approved For Prevention Of Bleeding ( PharmAsia-$)

Canada

  • Birth defects blamed on unapproved morning sickness treatment ( The Star)
  • Dangers of off-label drug use kept secret ( The Star)
  • How Important is a CADTH Recommendation for Reimbursement in Canada? ( Context Matters)
  • Canadian Democrats Push for New Drug Safety Measures ( HuffPo)

Other International

  • Australia's TGA joins EDQM’s CEP assessment process ( EDQM)
  • Philippines FDA Orders Recall Of All Batches Of India-Made Blood-Thinner ( PharmAsia-$)

Clinical Trials

  • Analysis of FDA warning letters reveals patient safety concerns ( MNT)

Regulatory Reconnaissance #345 – 26 June 2014

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.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney 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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