Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Google Working With FDA on Glucose-Monitoring Contact Lens (17 January 20

Regulatory Reconnaissance: Google Working With FDA on Glucose-Monitoring Contact Lens (17 January 2013)

Posted 17 January 2014 | By Alexander Gaffney, RAC 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org

In Focus: US

In Focus: International

  • South Africa slams Big Pharma in generic drugs row (Reuters) (Guardian)
  • EMA wants outcomes data on lipid-lowering agents (BioCentury) (EMA)
  • Indian Regulator mulls changes in labelling norms for drugs (Economic Times)
  • India Drug-Industry Leaders Call For Higher Standards In China, At Home (PharmAsia-$)

US: Pharmaceuticals/Biotechnology

  • Xarelto should not be approved in ACS says FDA panel (PMLive) (PharmaTimes) (Pharma Letter-$) (SCRIP-$) (Pink Sheet-$) (AP) (Forbes) (Press) (Fierce) (BioCentury) (Cardiovascular Business)
  • Mallinckrodt Pharmaceuticals New Drug Application Approved by the FDA (Press)
  • Over-The-Counter Pills Left Out of FDA Acetaminophen Limits (ProPublica)
  • Opinion: Thirty developed nations have approved Lemtrada. The U.S. refusal to do so shows the need for regulatory reform. (WSJ)
  • Opinion: Pharma Critics Want Complete Clinical Trial Transparency, Yet Want To Ban Publishing Pharma Funded Studies (Forbes)
  • U.S. shortage of Tamiflu for children resolved: Roche (Reuters) (Fierce)
  • Conflict Preemption: Would FDA Reject the Warning? (D&D Law)
  • Aegerion Hit With Shareholder Suit Over Juxtapid Labeling (Law 360-$)
  • Washington Legal Foundation Briefing: One Year After Caronia (WLF)
  • Ranbaxy asks the FDA to let it make generic Diovan in US (Fierce) (PharmAsia-$) (Fierce)

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

  • Prosensa considers developing muscle disorder drug after new data (Reuters) (BioCentury)
  • Trimel PDUFA Date for CompleoTRT Extended (Press)
  • Manufacturing Organs: Harvard Bioscience spin-off is stepping up its production of synthetic tracheas to supply clinical trials (MIT Tech Review)

US: Medical Devices

US: Dietary Supplements

  • DSHEA, 20 Years Later: Our Safe Harbor in a Sea of Never-ending Tumult (NPI)
  • NDI Compliance is Not Optional, Even as We Wait (NPI)

US: Assorted And Government

Upcoming Meetings And Events

  • 28 January 2014: Allergenic Products Advisory Committee Meeting (FDA)
  • 28 January 2013: US State of the Union Address (White House)
  • 28-29 January 2013: Workshop - Strategies to Address Hemolytic Complications of Immune Globulin Infusions (FDA)
  • 29-30 January 2014: Science Advisory Board to the National Center for Toxicological Research Meeting (FDA)
  • 19 February 2014: FDA OAGS Small Business Outreach Vendor Fair (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • EMA wants outcomes data on lipid-lowering agents (BioCentury) (EMA)
  • COMP Says Cometriq, Sirturo Still Orphan Drug Products; Deltyba, Para-aminosalicylic acid Lucane are not (EMA)
  • German Ruling Will Prevent Original Products Being Split For Distribution (Pink Sheet-$)
  • A QP for GMP? That is the suggestion: IRCA launches pharma auditor training (Outsourcing Pharma)
  • Europe: Early Communications with Regulators is Essential for SMEs (PharmExec)

Asia

  • Indian Regulator mulls changes in labelling norms for drugs (Economic Times)
  • India Drug-Industry Leaders Call For Higher Standards In China, At Home (PharmAsia-$)
  • Astellas' Ipragliflozin beats diabetes rivals to Japanese approval (PMLive) (Press)
  • Bayer Receives Approval for Riociguat in Japan for the Treatment of Chronic-Thromboembolic Pulmonary Hypertension (Press)
  • India Drug Regulator Said Mulling Tighter Label Rules To End Confusion (PharmAsia-$)
  • Panel favors continuation of ArQule liver cancer drug study (Reuters)

Other International

General Regulatory And Interesting Articles

  • Drug developers implementing new strategies for use of clinical trial comparator drugs (Pharma Letter-$)
  • Study: Warning labels can be dangerous to your health (Press)
  • Bodybuilders Bulk Up Using ... Cancer Drugs? (MedPage Today)
  • Belgian clinic repairs bones with new ground-breaking stem cell technique (Reuters)
  • Prozac during adolescence protects against despair in adulthood (LATimes)
  • New Research Shows No Significant Difference in Long-Term Experiences of Bone Marrow and Peripheral Blood Stem Cell (PBSC) Donors (Press)

Regulatory Reconnaissance #238 - 17 January 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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