Regulatory Focus™ > News Articles > Regulatory Recon: FDA Offers New Scope Cleaning Recommendations, Months After UCLA Outbreak (5 Augus

Regulatory Recon: FDA Offers New Scope Cleaning Recommendations, Months After UCLA Outbreak (5 August 2015)

Posted 05 August 2015 | By Michael Mezher 

Regulatory Recon: FDA Offers New Scope Cleaning Recommendations, Months After UCLA Outbreak (5 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

  • FDA to revise Novartis' Gilenya label to reflect brain infection risk (Reuters) (BioCentury) (Law360-$) (Pink Sheet-$) (FDA)
  • Over-the-Counter Pediatric Oral Liquid Drug Products Containing Acetaminophen (FDA)
  • FDA’s approval of first 3D-printed pill opens up endless possibilities for personalized medicine (Washington Post) (MedCityNews) (mHealthNews)
  • Antibiotic Resistance: The Next Step (Medpage Today)
  • FDA Issues New Cleaning Guide for Superbug-Prone Duodenoscopes (FDA) (Reuters) (Medpage Today)
  • FDA Says It's Impossible to Completely Clean Dirty Scopes (NBC News)
  • Guidance: Refuse to Accept Policy for 510(k)s (FDA)
  • Medical Device Makers Have No More Cybersecurity Excuses (MDDI)
  • Life Sciences Company Presents At White House Entrepreneurial Event (SCRIP-$)        

In Focus: International

  • Corruption Allegations in Romania: Company Responses (SCRIP-$)
  • TxCell: we’ll continue to use CMO even after we get back our GMP (BioPharma-Reporter)
  • Canada to Take Proactive Approach to Marijuana Advertising Enforcement (Health Canada)
  • Gilead confirms China talks on pricing for Sovaldi as country works on serious illness coverage (FiercePharmaAsia)
  • India defers free trade agreement talks with EU over ban of 700 pharma products (Economic Times)
  • Japanese Lab to Handle Ebola, Pathogens After 30 Years of Local Opposition (DD&D)              
  • Ebola Cases Fall Sharply, WHO Reports (NYTimes) (Reuters)

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US: Pharmaceuticals and Biotechnology

  • FDA to revise Novartis' Gilenya label to reflect brain infection risk (Reuters) (BioCentury) (Law360-$) (Pink Sheet-$) (FDA)
  • Over-the-Counter Pediatric Oral Liquid Drug Products Containing Acetaminophen (FDA)
  • FDA’s approval of first 3D-printed pill opens up endless possibilities for personalized medicine (Washington Post) (MedCityNews) (mHealthNews)
  • Regeneron Warns of Slow Praluent Uptake, While Eylea Fuels Growth (SCRIP-$)

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

  • FDA to review new drug application using Catalent softgel drug delivery tech (Outsourcing-Pharma)
  • Transgenomic Announces Pilot Clinical Study of its Multiplexed ICE COLD-PCR™ Liquid Biopsies (Press)

US: Pharmaceuticals and Biotechnology: General

  • FDA Looking For Consulting Org to Run DSCSA Pilots (RxTrace)
  • Antibiotic Resistance: The Next Step (Medpage Today)

US: Medical Devices

  • FDA Issues New Cleaning Guide for Superbug-Prone Duodenoscopes (FDA) (Reuters) (Medpage Today)
  • FDA Says It's Impossible to Completely Clean Dirty Scopes (NBC News)
  • Guidance: Refuse to Accept Policy for 510(k)s (FDA)
  • Medical Device Makers Have No More Cybersecurity Excuses (MDDI)
  • FDA Prioritizes Combo Product Reforms (Medical Device CRO Blog)
  • Some Medical Device Companies Leverage Clinical Trials to Supplement FDA Submissions and Enhance Marketing Messages (Cutting Edge Info)
  • The Top Three Medical Device Applications for 3-D Printing (Manufacturing Geek Blog)
  • Ulthera Announces Two Year FDA Clearance for Cellfina System (Press)
  • Ultrafast DNA Diagnostics Results From Heating, Cooling With Light (Press)
  • Light Used as Pacemaker to Set Rhythm of Beating Heart (medGadget)
  • Elekta Receives US 510(k) Clearance for Its Latest Generation Intracranial Radiosurgery System (Press)
  • PhysIQ receives FDA 510(k) clearance for physiology analytics engine (MobiHealthNews)
  • FDA Reclassifies Internal Tissue Marker to Class II (FDA)

US: Assorted and Government

  • FDA raises its PDUFA and MDUFA user fees (MedCityNews)
  • Life Sciences Company Presents At White House Entrepreneurial Event (SCRIP-$)               

Upcoming Meetings and Events                                                            

Europe

  • Corruption Allegations in Romania: Company Responses (SCRIP-$)
  • TxCell: we’ll continue to use CMO even after we get back our GMP (BioPharma-Reporter)
  • EMA and Patient, Healthcare Groups to Hold Joint Workshop on Risk Minimization (EMA)
  • Amgen's Repatha Authorized in EU (EC)
  • Appoint pharmacy champions to lead introduction of biosimilars, says NICE (Pharmaceutical Journal)

Canada

  • Canada to Take Proactive Approach to Marijuana Advertising Enforcement (Health Canada)
  • Sorin Group Obtains Health Canada Approval for Perceval, Its Next Generation Sutureless Valve (Press)

India

  • India defers free trade agreement talks with EU over ban of 700 pharma products (Economic Times)
  • Nearly 50 Chinese pharma firms to set up operations in India (BioSpectrum)
  • Indian and Chinese API Manufacturers in the Focus of European Authorities (GMP Compliance)
  • Government mulls providing over 50 essential drugs at cheaper rates (Economic Times)
  • Better outlook for clinical trials in India (PharmaPhorum)

China

  • CFDA drafts new drug review initiatives (BioCentury)
  • Gilead confirms China talks on pricing for Sovaldi as country works on serious illness coverage (FiercePharmaAsia)

Japan

  • Japan debating its restrictions on cell phone usage due to doubts about their impact on pacemakers (FierceMedicalDevices)
  • Japanese Lab to Handle Ebola, Pathogens After 30 Years of Local Opposition (DD&D)              

Ebola Outbreak

Other International

  • Tender still important to maintain New Zealanders’ access to medicines, says PHARMAC chief (PharmaLetter-$)
  • WHO Technical Report - GMP for Biological Products Revision (GMP Compliance)

Regulatory Reconnaissance #611– 5 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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