Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Device Interoperability Guidance Coming, FDA Says (7 February 2014)

Regulatory Reconnaissance: Device Interoperability Guidance Coming, FDA Says (7 February 2014)

Posted 07 February 2014 | By Alexander Gaffney, RAC 

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In Focus: US

  • FDA to offer draft guidance on interoperability of medical devices (Modern Healthcare)
  • Hamburg: FDA regulation not 'one size fits all' (BioCentury) (FDA) (Modern Healthcare)
  • FDA: shortage mitigation measures working thanks to drugmakers (In Pharma) (FDA)
  • FDA Should Create "Clearly Articulated Pathway" For Patient-Centered Research - Pfizer's Lewis-Hall (Pink Sheet-$)

In Focus: International

  • EU SCOPE Project Will Harmonize Pharmacovigilance, Benefit Industry (Pink Sheet-$)
  • Trialogue hopes on proposed EU Device Regulations fade for H1 (Clinica-$)
  • eSubmission Gateway or web client mandatory for all eCTD submissions through the centralised procedure from 1 March 2014  (EMA)
  • Roche wins battle against India sales of generic cancer drug Herceptin (FT-$)
  • Leukemia drug BMS's Sprycel may lose patent shield (India Times)
  • Aussie Court Approves Thalidomide Firm's $89 Million Settlement Of Suits (PharmAsia-$) (Guardian)

US: Pharmaceuticals/Biotechnology

  • Hamburg: FDA regulation not 'one size fits all' (BioCentury) (FDA) (Modern Healthcare)
  • FDA: shortage mitigation measures working thanks to drugmakers (In Pharma) (FDA)
  • FDA Should Create "Clearly Articulated Pathway" For Patient-Centered Research - Pfizer's Lewis-Hall (Pink Sheet-$)
  • Merck Said to Agree to $100 Million NuvaRing Settlement (Bloomberg)
  • LAWSUIT: Ex-sales rep accuses Celgene of illegal Thalomid, Revlimid schemes (SCRIP-$) (Pharma Letter-$) (Pharmafile) (Law 360-$) (Bloomberg)
  • FDA Seeks Chewing Gum Dissolution Tester (FDA)
  • Despite pomp and circumstance, 2014's looking short on blockbusters (Fierce)
  • DEA Receives Hydrocodone Rescheduling Request; Petition Seeks To Halt Process (IHP-$)
  • HHS Inspector General To Probe CMS' Oversight Of Drug Compounding (IHP-$)
  • Novartis Sues Dr. Reddy's Over ANDA For Cancer Drug (Law 360-$)
  • Fed. Circ. OKs Ruling Barring Generic Lyrica Until 2018 (Law 360-$)
  • FDA's MedWatch Safety Alerts: January 2014 (FDA)

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

  • Shire's ADHD drug fails in depression trial (PMLive) (Reuters)
  • Merck Plans Rolling NDA Submission of Cancer Drug This Year (Bloomberg)
  • Gardasil inventor Professor Ian Frazer's new genital herpes vaccine proves safe in passing first human trials (Courier Mail)
  • Striking a Nerve: Allergy Drug Tested for MS (MedPage Today)
  • Drug shows promise in kids with autism, researchers say (USA Today) (Bloomberg)

US: Pharmaceuticals and Biotechnology: General

  • Clinical Trial Data At Heart Of Landmark Wall Street Insider Trading Scandal (Forbes) (SCRIP-$)
  • Scientific American Editos: End the Ban on Psychoactive Drug Research (Scientific American)
  • California widens access to naloxone, drug that can reverse heroin overdose (CBS)
  • Breaking the Bond of Heroin and Painkillers (Bloomberg)
  • In Pursuit Of Counterfeit Drug Kingpins: Interchange 2013 (Safe Medicines)

US: Medical Devices

US: Dietary Supplements

US: Assorted And Government

  • Sunshine Act Deadline Is Still Cloudy As Registration Not Yet Available (Pink Sheet-$)

Upcoming Meetings And Events

  • 10 February 2014: E&C Committee on Drug Shortage Problem (E&C)
  • 19 February 2014: FDA OAGS Small Business Outreach Vendor Fair (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • EU SCOPE Project Will Harmonize Pharmacovigilance, Benefit Industry (Pink Sheet-$)
  • Trialogue hopes on proposed EU Device Regulations fade for H1 (Clinica-$)
  • Regulations are 'hindering conversations' (Pharma Times)
  • eSubmission Gateway or web client mandatory for all eCTD submissions through the centralised procedure from 1 March 2014  (EMA)
  • CMDh releases new submission requirements for MRP, DCP and national procedures (Exalon)
  • New versions of the EU electronic Application Forms released (MAA, variation, renewal) (Exalon)
  •  Patient Safety: New EU Rapid Alert platform for human Blood and Blood Components (EC)
  • UK Police will have 'backdoor' access to health records despite opt-out, says MP (Guardian)

India

  • Roche wins battle against India sales of generic cancer drug Herceptin (FT-$)
  • Leukemia drug BMS's Sprycel may lose patent shield (India Times)

Japan & China

  • Post-Approval Change Regulatory Burden Draws Heat at Japan CMC Strategy Forum (IPQ-$)

Other International

  • Aussie Court Approves Thalidomide Firm's $89 Million Settlement Of Suits (PharmAsia-$) (Guardian)
  • Health Canada releases information regarding the electronic Submission Gateway (Exalon)

General Regulatory And Interesting Articles

  • The case for improving biosimilar regulatory frameworks worldwide (GaBi)
  • A Way To Increase Drug R&D Success Rates (Forbes)
  • Dr. House Helps Diagnose Heart Failure From Hip Implants (Bloomberg)

Regulatory Reconnaissance #252 - 7 February 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.


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