Regulatory Focus™ > News Articles > Regulatory Recon: Should FDA Guidance on Mobile Apps be Made Permanent? (22 July 2014)

Regulatory Recon: Should FDA Guidance on Mobile Apps be Made Permanent? (22 July 2014)

Posted 22 July 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: Should FDA Guidance on Mobile Apps be Made Permanent? (22 July 2014)

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In Focus: US

  • GOP Tries To Codify FDA’s Guidance Policy On Low-Risk Mobile Devices (Gray Sheet-$)
  • Top Deficiencies Found in CDER’s Micro Review of Regulatory Submissions Include Incomplete Information on Validation of Aseptic and Terminal Sterilization Processes (IPQ-$)
  • Developing a Policy for Correcting Third Party Misinformation (Eye on FDA)
  • EPA May Threaten Reverse Distribution Of Pharmaceuticals (Law 360-$)
  • Boston Scientific Receives FDA Approval for REBEL Platinum Chromium Coronary Stent System (Press) (Mass Device)
  • Patient groups argue for faster med tech FDA approvals at industry meeting (Fierce)

In Focus: International

  • Indian Regulators Want Price Control Scheme for Medical Devices (PharmaBiz)
  • DCGI sets up Independent Expert Committee on Oncology for trial deaths caused by cancer drugs (PharmaBiz)
  • New cancer drugs approvals in Canada delayed due to extra layer of bureaucratic review (Pharma Letter-$)
  • MedDRA Update Posted, Call for Comments (MedDRA)

US: Pharmaceuticals and Biotechnology

  • FDA Will Support Efforts to Upgrade Micro Methods and Processes, CDER Reviewer Affirms (IPQ-$)
  • Top Deficiencies Found in CDER’s Micro Review of Regulatory Submissions Include Incomplete Information on Validation of Aseptic and Terminal Sterilization Processes (IPQ-$)
  • Developing a Policy for Correcting Third Party Misinformation (Eye on FDA)
  • FDA Social Media Draft Guidances Answer Some Questions, Raise Others (CHC)
  • EPA May Threaten Reverse Distribution Of Pharmaceuticals (Law 360-$)
  • FDA Names Acting Head of India Office (India Today)
  • FDA panel to discuss NPS's Natpara (BioCentury)
  • FDA to discuss best practices for developing biomarkers (BioCentury)
  • Why Cyclacel, FDA devised novel protocol for AML Phase III (BioCentury-$)
  • FDA Spars With Recalcitrant Compounding Pharmacy, Again (Pharmalot)
  • American Health Packaging Announces the Voluntary Nationwide Recall of Ibuprofen Tablets (FDA) (FDA)
  • Seizures in horses in Kentucky focus attention on drug compounding (Fierce)

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

  • SAGE Therapeutics Receives Fast Track Designation for Lead Compound SAGE-547 to Treat Status Epilepticus (Press)
  • FDA Grants Genentech’s Avastin Priority Review for Recurrent Platinum-Resistant Ovarian Cancer (Press)
  • ViiV says Phase III maraviroc study shows inferior efficacy to emtricitabine/tenofovir (Pharma Letter-$)

US: Pharmaceuticals and Biotechnology: General

US: Medical Devices

  • Boston Scientific Receives FDA Approval for REBEL Platinum Chromium Coronary Stent System (Press) (Mass Device)
  • Patient groups argue for faster med tech FDA approvals at industry meeting (Fierce)
  • GOP Tries To Codify FDA’s Guidance Policy On Low-Risk Mobile Devices (Gray Sheet-$)
  • Two UL Battery Safety Standards Are now FDA Recognized Consensus Standards for Medical Devices (Press)
  • CDRH Looking to Hire New Associate Director for Management (FDA)
  • Teleflex Receives FDA Clearance for ARROW-ClarkTM VectorFlow Chronic Hemodialysis Catheter (Press)
  • CorMatrix Reports FDA Clearance of CorMatrix ECM for Vascular Repair (Press)
  • Access Pharmaceuticals Receives 510(K) FDA Marketing Clearance For ProctiGard (Press)

US: Dietary Supplements

  • Supplement GMP Inspections Reveal Adverse Event Reports, Prompting Warning Letters (Tan Sheet-$)

Europe

India

  • Indian Regulators Want Price Control Scheme for Medical Devices (PharmaBiz)
  • DCGI sets up Independent Expert Committee on Oncology for trial deaths caused by cancer drugs (PharmaBiz)
  • India wants price controls on cancer generics (BioCentury)
  • Centre insistence on 6 months time frame for trial approvals by DCGI helps to pick up clinical research in India (PharmaBiz)
  • 14 drugs made in Himachal Pradesh fail tests (Times of India)

Canada

  • New cancer drugs approvals in Canada delayed due to extra layer of bureaucratic review (Pharma Letter-$)

Other International

  • MedDRA Update Posted, Call for Comments (MedDRA)
  • Malaysian medical device regulators change requirements for docs, AI requests (Mass Device)

Clinical Trials

  • Is the SDV in Risk-based Monitoring Misunderstood? (Polaris)
  • Helping Patients Connect to Trials by Sharing Better Information (Eli Lilly COI)

Regulatory Reconnaissance #362 – 22 July 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.

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.


Categories: Recon, Regulatory News

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