Regulatory Focus™ > News Articles > Regulatory Recon: FDA Says Biosimilars Guidance Coming Soon (5 December 2014)

Regulatory Recon: FDA Says Biosimilars Guidance Coming Soon (5 December 2014)

Posted 05 December 2014 | By Alexander Gaffney, RAC

Regulatory Recon: FDA Says Biosimilars Guidance Coming Soon (5 December 2014)

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

In Focus: US

  • Biosimilar Guidances Expected In ‘Near Future,’ But Unnecessary, FDA Says ( Pink Sheet-$) ( The Hill)
  • FDA Approves Jakafi for Patients with Uncontrolled Polycythemia Vera ( Press) ( FDA) ( PharmaTimes) ( SCRIP-$)
  • Texas “Right to Try” Bill Would Nullify Some FDA Regulations, Help Terminally-Ill ( 10th Amendment Center)
  • FDA resolves criminal and civil actions against Main Street Family Pharmacy ( FDA)
  • Streamlined Antibiotic Development Programs Gain FDA Panel Backing ( Pink Sheet-$) ( Tarius)
  • Sens. Look To Block FDA Oversight Of Medical Apps ( Law 360-$) ( Senate)
  • 4 Gaps In QSIT That, If Bridged, Will Better Focus FDA Inspections ( Silver Sheet-$)
  • Preparing Your Organization for new FDA Requirements and eMDR ( SpartaSystems)

In Focus: International

  • Medical Device Authority Lands With DG Enterprise ( MedicalDevicesLegal)
  • GVK Bio manipulated clinical trials of generic drugs: Reports ( PTI)
  • Sun Pharma Says Data Integrity Improved After FDA Warning Letter ( Bloomberg)
  • Why do Indian health authorities keep quiet on pharma firms' failings? ( Business Standard)
  • SICA and its Efforts for the Harmonization of Medicine Regulation ( Thompson Reuters)
  • WHO Touts its Prequalification Scheme ( In-Pharma)

US: Pharmaceuticals and Biotechnology

  • Biosimilar Guidances Expected In ‘Near Future,’ But Unnecessary, FDA Says ( Pink Sheet-$) ( The Hill)
  • FDA Approves Jakafi for Patients with Uncontrolled Polycythemia Vera ( Press) ( FDA) ( PharmaTimes) ( SCRIP-$)
  • Texas “Right to Try” Bill Would Nullify Some FDA Regulations, Help Terminally-Ill ( 10th Amendment Center)
  • FDA resolves criminal and civil actions against Main Street Family Pharmacy ( FDA)
  • Streamlined Antibiotic Development Programs Gain FDA Panel Backing ( Pink Sheet-$) ( Tarius)
  • More Track-And-Trace Guidance Coming; Industry Seeks Stronger Federal Preemption Rules ( FDAnews-$)
  • Researchers struggle to gauge risks of childhood anesthesia ( ScienceMag)
  • Industry Pushes Back Against FDA’s Quality Culture Metrics ( FDAnews-$)
  • $135 million plan eyed to compensate victims of New England Compounding Center's contaminated steroids ( Mass Live)
  • FDA Explains USP's Salt Policy ( FDA)
  • H3N2 flu 'drift' alarm too late for vaccine ( SCRIP-$)
  • Carly's Law supporters blame FDA for stalling approval of study to treat severe seizures ( Alabama)
  • FDA Tentatively Approves Mylan’s Pediatric Formulations of Abacavir/Lamivudine for HIV ( Press)

US: Pharmaceuticals and Biotechnology: Clinical StudyResults, Filings and Designations

  • ADMA will submit BLA on Phase III RI-002 results ( Press)
  • Cellectar Biosciences Granted Orphan Designation for I-131-CLR1404 for the Treatment of Multiple Myeloma ( Press)

US: Pharmaceuticals and Biotechnology: General

  • Early Data Suggests Potentially Severe Flu Season ( CDC) ( WaPo) ( SCRIP-$)

US: Medical Devices

  • 4 Gaps In QSIT That, If Bridged, Will Better Focus FDA Inspections ( Silver Sheet-$)
  • Medical Device Cybersecurity, Terrorism, and a Leap Too Far? ( MDDI)
  • Sens. Look To Block FDA Oversight Of Medical Apps ( Law 360-$) ( Senate)
  • Blackburn aims to get SOFTWARE Act on Obama’s desk early next year ( MobiHealthNews)
  • Unique Device Identifiers (UDIs): A Roadmap for Effective Implementation ( Brookings)
  • Preparing Your Organization for new FDA Requirements and eMDR ( SpartaSystems)
  • How to Launch the Country's First-Ever Medical Device Tracking System ( Brookings)
  • Your Annual Reminder that Personal Lubricant is a Medical Device ( Press)
  • FDA Closes Out Inspections of Atossa Genetics ( Press)
  • FDA Clears DePuy Thoracis Device ( Press)
  • ArtVentive Medical Receives FDA Clearance for EOS Device ( Press)
  • Fiagon Receives FDA Clearance for ENT Extended Instrument Set ( Press)
  • Class 1 Recall for 9 ConMed Corporation Devices ( FDA)

US: Assorted And Government

Upcoming Meetings

Europe

  • Medical Device Authority Lands With DG Enterprise ( MedicalDevicesLegal)
  • Funding rare disease treatments in the UK – navigating the labyrinth ( PharmaPhorum)
  • Teva Receives Positive Outcome in Europe for Three-Times-a-Week COPAXONE ( Press)

India

  • GVK Bio manipulated clinical trials of generic drugs: Reports ( PTI)
  • Sun Pharma Says Data Integrity Improved After FDA Warning Letter ( Bloomberg)
  • Why do Indian health authorities keep quiet on pharma firms' failings? ( Business Standard)
  • Indian Court Clears Mylan’s Atazanavir Exports ( PharmAsia-$)
  • Industry may comply with notification banning PET bottles for packaging in six months' time ( PharmaBiz)

China

  • China To End Organ Harvesting From Executed Inmates ( NPR) ( Reuters)

Canada

  • International Harmonized Requirements for Batch Certification ( Health Canada)

Other International

  • SICA and its Efforts for the Harmonization of Medicine Regulation ( Thompson Reuters)
  • WHO Touts its Prequalification Scheme ( In-Pharma)
  • Pakistani blood transfusions spreading hepatitis, HIV ( Reuters)

Clinical Trials

  • What Happens When Results Data From Clinical Trials Goes Missing? ( Pharmalot)

General Regulatory And Interesting Articles

  • Cancer’s Super-Survivors ( WSJ)

Regulatory Reconnaissance #453 – 5 December 2014

RegulatoryReconnaissance 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 @AlecGaffney orsend 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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