Regulatory Focus™ > News Articles > Regulatory Recon: UK Unveiling Device Safety Changes (21 July 2014)

Regulatory Recon: UK Unveiling Device Safety Changes (21 July 2014)

Posted 21 July 2014 | By Alexander Gaffney, RAC

Regulatory Recon: UK Unveiling Device Safety Changes (21 July 2014)

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In Focus: US

  • FDA’s Stern Warning On Data Integrity: “Sometimes Lawyers Become Too Clever For Their Own Good” (Pink Sheet-$)
  • FDA’s Intervening NDA Approval Policy Strikes Again; Agency Denies Antares Petition on Methotrexate (FDA Law Blog)
  • FDA Review “Program” Tweaks May Include Smaller Mid-Cycle Meetings (RPM Report-$)
  • The "One Click Rule"—The "Rule" That Isn't (RegulatoryRx)
  • FDA warns consumers against powdered caffeine (The Hill) (FDA) (NBC)

In Focus: International

  • MHRA ups its game on medical device safety (OnMedica) (MHRA) (Clinica-$)
  • UK research body to toughen up on trial registration and reporting (SCRIP-$)
  • The European Pharmacopeia Commission validates strategy regarding elemental impurities and upcoming ICH Q3D guideline (EDQM)
  • Italy adds another hurdle for IVD makers (Clinica-$)
  • Indian clinical trial approvals see early spike in 2014 (Outsourcing Pharma)
  • New condom that attacks herpes, HIV on sale 'within months' (AAP) (RTT)

US: Pharmaceuticals and Biotechnology

  • FDA’s Stern Warning On Data Integrity: “Sometimes Lawyers Become Too Clever For Their Own Good” (Pink Sheet-$)
  • FDA’s Intervening NDA Approval Policy Strikes Again; Agency Denies Antares Petition on Methotrexate (FDA Law Blog)
  • FDA Review “Program” Tweaks May Include Smaller Mid-Cycle Meetings (RPM Report-$)
  • The "One Click Rule"—The "Rule" That Isn't (RegulatoryRx)
  • Patient Advocacy And PDUFA VI: Next Steps Could Include Involvement In Reviews, More Scientific Briefings for FDA Staff (RPM Report-$)
  • Completeness Assessment of Type II Active Pharmaceutical Ingredient Drug Master Files under Generic Drug User Fee Amendment: Review Metrics and Common Incomplete Items. (PubMed)
  • FDA Meeting: Advancing the Use of Biomarkers and Pharmacogenomics (FDA)
  • FDA AdComm to Assess NPS Pharma's NATPARA (FDA)
  • "Right to Try" Bill Introduced in Michigan (SBM)
  • How Rare Disease Patients are Revolutionizing Regulation (BioCenturyTV)
  • FDA Urged To Add New Black Box Warning On J&J's Levaquin (Law 360-$)
  • 21st Century Cures to hold personalized medicine roundtable  (BioCentury) (E&C)
  • DSCSA: Special Privileges For The “Big-3″ Wholesale Distributors, Part 1 (RxTrace)
  • Unique Pharmaceuticals, Ltd. Announces a Voluntary Nationwide Recall of all Sterile Compounded Preparations Within Their Expiry Period Due to a Lack of Sterility Assurance (FDA)
  • Baxter IV Sodium Chloride and Potassium Chloride Solutions: Recall - Particulate Matter (FDA)
  • Sterile Drug Products by Downing Labs (aka NuVision Pharmacy): Drug Alert - Lack of Sterility Assurance (FDA) (FDA)

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

  • Aduro BioTech Receives Breakthrough Therapy Designation from FDA for Innovative Pancreatic Cancer Combination Immunotherapy (Press)
  • Regulus Receives Orphan Drug Designation for RG-012, a microRNA Therapeutic for the Treatment of Alport Syndrome (Press)
  • Gilead Drug Combination Cures Hepatitis C in HIV Patients (Bloomberg)

US: Pharmaceuticals and Biotechnology: General

  • Missouri Alone in Resisting Prescription Drug Database (NYTimes)
  • Database of Industry Payments has an Error Message for Those Who Don't Take Funding (MedPage Today)
  • As New York Embraces HIV-Preventing Pill, Some Voice Doubts (NPR)
  • Biosimilars will not erode sales like generics, says J&J (BioPharma Reporter)
  • US Capitol Capsule: What's life & limb worth? Gauging antibiotics' value (SCRIP-$)
  • U.S. Medicare program scales back hospice drugs restrictions (Reuters)

US: Medical Devices

  • FDA clears Bausch + Lomb’s device for laser-assisted lens fragmentation in cataract surgery (MedCity News)
  • Summit Medical, Inc. Receives FDA 510(k) Clearance for Additional Sterilization Cycles (Press)
  • Expanding Orthopedics Inc. has obtained FDA Clearance for its FLXfit™, the world's first 3D expandable interbody cage (Press)
  • Varian Medical Systems Receives FDA 510(k) Clearance for Calypso® Soft Tissue Beacon® Transponder (Press)
  • Class 1 Recall for CO2 Detector Made by GE (FDA)
  • Pakistan Device Maker Conendo Surgical Under Import Alert as of 11 July 2014 (FDA)

US: Dietary Supplements

  • FDA warns consumers against powdered caffeine (The Hill) (FDA) (NBC)
  • Cognitive health claims range from sublime to ridiculous, experts say (NI-USA)
  • States Sue 5-Hour Energy Over Ad Claims (AP)

Europe

  • MHRA ups its game on medical device safety (OnMedica) (MHRA) (Clinica-$)
  • UK research body to toughen up on trial registration and reporting (SCRIP-$)
  • The European Pharmacopeia Commission validates strategy regarding elemental impurities and upcoming ICH Q3D guideline (EDQM)
  • Italy adds another hurdle for IVD makers (Clinica-$)
  • UK industry groups want Drs to use biosimilar names not INNs (BioPharma Reporter)
  • EMA mulls easing labs' adoption of in vivo batch test alternatives (Outsourcing Pharma)
  • Life-threatening reactions to diet drug on the rise in the UK (Reuters)

India

  • Indian clinical trial approvals see early spike in 2014 (Outsourcing Pharma)
  • Eli Lilly unhappy with National Pharmaceutical Pricing Authority, calls for consultative approach (India Times)

Australia

  • New condom that attacks herpes, HIV on sale 'within months' (AAP) (RTT)

Other International

  • Proceedings: International Regulatory Considerations on Development Pathways for Cell Therapies (PubMed)

General Regulatory And Interesting Articles

  • Tasmania, Big Supplier to Drug Companies, Faces Changes (NYTimes)
  • Biomedical technologies may be improved by protein in squid skin (MNT)

Regulatory Reconnaissance #361 – 21 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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