Regulatory Focus™ > News Articles > Regulatory Recon: Medical Device Task Force Releases Recommendations for National Evaluation System

Regulatory Recon: Medical Device Task Force Releases Recommendations for National Evaluation System (25 August 2015)

Posted 25 August 2015 | By Michael Mezher 

Regulatory Recon: Medical Device Task Force Releases Recommendations for National Evaluation System (25 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

  • Medical Device Epidemiology Network Registry Task Force Report (FDA)
  • No More Biomarker Fumbling; Time to Get Serious (SCRIP-$)
  • FDA extends use of Promacta in young children with rare blood disorder (FDA) (PharmaLetter-$) (Press) (DD&D)
  • DTC Print Ads: NEJM, Industry Critique FDA Guidance For Clarifying Risk Info (Pink Sheet-$)
  • This New Test For Antibiotic Drug Resistance Could Be A Game Changer (Forbes)
  • FDA Approval Of Second PCSK9 Inhibitor Expected Soon (CardioBrief)
  • The drug development and approval process is about much more than the final “okay” (The Catalyst)
  • Reagan-Udall Foundation Builds Portfolio of Drug Regulatory and Safety Projects (PharmTech)
  • Stubborn FDA Invites Court Fights, Sidley Austin Atty Says (Law360-$)
  • OIG Says Certain Free Drug Starter Programs May Be OK (Law360-$)

In Focus: International

  • Melanoma app gains favor in Europe (mHealthNews)
  • UK Health Secretary Announces Mandatory "Sunshine Rule" After Investigation Into Industry Relationships With NHS Employees (Policy and Medicine)
  • European Commission seeking Comments on Draft Text laying out the Safety Features to appear on Pharmaceutical Packaging (FDA Life)
  • AZ-Glenmark Saxagliptin Case Heads For Settlement? (SCRIP-$)
  • Drug testing labs at Rajasthan to recruit staff towards ensuring drug quality (PharmaBiz)
  • China Progresses Sequencing Tech Under Precision Medicine Strategy (PharmAsiaNews-$)
  • Stem cell laws in Japan a magnet for research, Nikkei says (FiercePharmaAsia)
  • ANVISA Planned Changes to Impact Class I, II Medical Devices and IVDs in Brazil (Emergo)
  • Restructuring To Speed Registrations in Turkey? (PharmAsiaNews)

US: Pharmaceuticals and Biotechnology

  • No More Biomarker Fumbling; Time to Get Serious (SCRIP-$)
  • FDA extends use of Promacta in young children with rare blood disorder (FDA) (PharmaLetter-$) (Press) (DD&D)
  • DTC Print Ads: NEJM, Industry Critique FDA Guidance For Clarifying Risk Info (Pink Sheet-$)
  • This New Test For Antibiotic Drug Resistance Could Be A Game Changer (Forbes)
  • Scientists Uncover Surprising Mechanism Behind Antibiotic-Resistant Bacteria (DD&D)
  • US FDA OK with a bit of blue: Colorcon's Spirulina approved for pharma pills (In-Pharma Technologist)
  • FDA Approval Of Second PCSK9 Inhibitor Expected Soon (CardioBrief)

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

  • Vital Regroups after Bio-Artificial Liver fails in Phase III (SCRIP-$)
  • FDA Grants Breakthrough Designation to Exelixis’ Cancer Drug Cabozantinib (FDANews-$)
  • Scripps and Janssen make major advance on more effective, long-lasting flu vaccine (PharmaLetter-$)
  • Bavituximab and durvalumab combo to be evaluated in solid tumours (EuropeanPharmaceuticalReview)
  • Drug Protects Against Effects of Nuclear Radiation (PharmPro)
  • Phase III study data for Fycompa in PGTC seizures published (EuropeanPharmaceuticalReview)
  • Bristol-Myers Squibb and Pfizer to Present New Data on Eliquis (apixaban) at the ESC Congress 2015 (Press)
  • FDA and EMA accept applications for Boehringer Ingelheim’s Giotrif/Gilotrif for treatment of advanced squamous cell carcinoma of the lung (Press)
  • Positive results from latest Phase III trial of Eisai's Fycompa (PharmaLetter-$) (MNT)
  • New Microbiome Therapy Granted Orphan Drug Designation for Recurrent CDI (MPR)
  • FDA Accepts Keytruda sBLA for First-Line Melanoma Indication (MPR)
  • RetroSense Therapeutics’ Lead Gene Therapy Candidate Gets FDA Clearance to Proceed to First-in-Human Clinical Trials (Press)
  • BTD in hand, Exelixis speeds cabo application to FDA (FierceBiotech)
  • Acute Pulmonary Embolism Trial (SEATTLE II) Published in the JACC: Cardiovascular Interventions (Press)
  • Alkermes (ALKS) Says FDA Will Breifly Delay Action Date for Aristada (BioSpace)
  • TiGenix Rises On 'Landmark' Phase III Crohn's Data (SCRIP-$) (MNT)

US: Pharmaceuticals and Biotechnology: General

  • The drug development and approval process is about much more than the final “okay” (The Catalyst)
  • Reagan-Udall Foundation Builds Portfolio of Drug Regulatory and Safety Projects (PharmTech)
  • FDA Sets Expectations for Improving Therapeutic Consistency in the Development of Botanical Drugs (FDA Law Blog)
  • Allergan Issues Voluntary Nationwide Recall In The U.S. Of Specific Lots af Opthalmic Ointment (FDA)

US: Medical Devices

  • Medical Device Epidemiology Network Registry Task Force Report (FDA)
  • Medeon Biodesign Receives FDA 510(k) Clearance for ClickClean(TM) - Laparoscope Lens Cleaning Device (Press)
  • FDA Approves Dexcom G5® Mobile Continuous Glucose Monitoring System (Press)
  • FDA Hikes Fees For Med Device Export Certificates (MedDeviceOnline)
  • St. Jude Medical wins CE Mark for Prodigy MRI pain device (MassDevice)
  • Six ways to implement privacy and security measures (MassDevice)
  • Researchers ready consumer STD-detecting, connected ring for Indiegogo in early 2016 (FierceMedicalDevices)
  • Google Parent Spins Off Firm With Medical Device-Focused Pipeline (Gray Sheet-$)
  • Citing survey, Abbott says concussion diagnostic needed (FierceMedicalDevices)
  • Si-Bone touts data from 3 study results (MassDevice)
  • Why Practice Fusion and Theranos Will Disrupt Lab Testing On Electronic Health Record Platforms (Forbes)

US: Assorted and Government

  • Stubborn FDA Invites Court Fights, Sidley Austin Atty Says (Law360-$)
  • Medtronic Wins Dismissal Of Remaining Claims In Infuse Suit (Law360-$)
  • Blow for Takeda as Velcade US patent ruled invalid (PharmaLetter-$)
  • Bass Denied Trials In Acorda Patent Challenges; Shares Soar (SCRIP-$)
  • OIG Says Certain Free Drug Starter Programs May Be OK (Law360-$)
  • 340B 'Penny Pricing' Policy Draws Manufacturers' Ire (Pink Sheet-$)
  • PTSD Patients Sue over Colorado Marijuana Decision (PharmPro)
  • Rhode Island move to mandate HPV vaccine in schools faces criticism (Reuters)

Upcoming Meetings and Events

Europe

  • Daiichi Sankyo starts patient registration for new heart-condition drug in Europe (PharmaLetter-$)
  • Melanoma app gains favor in Europe (mHealthNews)
  • UK Health Secretary Announces Mandatory "Sunshine Rule" After Investigation Into Industry Relationships With NHS Employees (Policy and Medicine)
  • FDA and EMA accept applications for Boehringer Ingelheim’s Giotrif/Gilotrif for treatment of advanced squamous cell carcinoma of the lung (Press)
  • European Commission seeking Comments on Draft Text laying out the Safety Features to appear on Pharmaceutical Packaging (FDA Life)

Canada

Australia

  • Hazard Alert: St Jude implantable devices used with Merlin@home transmitter (TGA)

India

  • AZ-Glenmark Saxagliptin Case Heads For Settlement? (SCRIP-$)
  • Drug testing labs at Rajasthan to recruit staff towards ensuring drug quality (PharmaBiz)
  • Glenmark expecting USFDA nod for 4-6 products this fiscal year (Economic Times)

China

  • China To Roll Out More New Rules In Coming Months (Clinica-$)
  • BeiGene to build cGMP production plant for commercial use in Suzhou, China (PharmaLetter-$)
  • China Progresses Sequencing Tech Under Precision Medicine Strategy (PharmAsiaNews-$)

Japan

  • Stem cell laws in Japan a magnet for research, Nikkei says (FiercePharmaAsia)
  • Daiichi Sankyo Espha’s TB drugs approved in Japan (BioSpectrum)

Ebola Outbreak

  • WHO staff on the ground essential to breaking Ebola transmission chains (PharmaAfrica)
  • With many Ebola survivors ailing, doctors evaluate situation (Washington Post)
  • Ebola Diaries: A Psychological Toll to Endure (ICT)
  • Sierra Leone releases last known Ebola patient from hospital (Reuters)

Other International

  • ANVISA Planned Changes to Impact Class I, II Medical Devices and IVDs in Brazil (Emergo)
  • Restructuring To Speed Registrations in Turkey? (PharmAsiaNews)

General Health and Other Interesting Articles

  • Humans Carry More Antibiotic-Resistant Bacteria Than Animals (ICT)

Regulatory Reconnaissance #625 – 25 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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