Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Could Google Glass Soon Undergo FDA Review? (10 January 2013)

Regulatory Reconnaissance: Could Google Glass Soon Undergo FDA Review? (10 January 2013)

Posted 10 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

  • Google X Staff Meet With FDA Pointing Toward New Device (Bloomberg)
  • Appropriators Poised To Give FDA $85 Million In Sequestered User Fees (IHP-$)
  • Justice Department Investigating Aegerion Over Marketing Of New Cholesterol Drug (Forbes) (Reuters) (AP)
  • ANDA Submissions Explode in December - The GDUFA Goal Letter May Expose the OGD Donut Hole (Lachman)
  • DC Circ. Revives K-V's FDA Enforcement Row (Law 360-$) (FDA Law Blog)
  • FDA approves first gel for sealing corneal incision after cataract surgery (FDA) (Press) (Mass Device)

In Focus: International

  • EU panel recommends suspension of Servier's risky bone disease drug Protelos (Reuters) (EMA)
  • EU extends electronic equipment critical substances time limit (Clinica-$)
  • More Than 30% Sterile Drug Producers In China Fail To Meet GMP Deadline (PharmAsia-$)
  • Brazil ANVISA public meeting on drug serialization, tracking system set (TraceLink)

US: Pharmaceuticals/Biotechnology

  • Justice Department Investigating Aegerion Over Marketing Of New Cholesterol Drug (Forbes) (Reuters) (AP)
  • ANDA Submissions Explode in December - The GDUFA Goal Letter May Expose the OGD Donut Hole (Lachman)
  • Pre-"Complete Response" Deficiency Communication Possible For ANDA Sponsors (Pink Sheet-$)
  • DC Circ. Revives K-V's FDA Enforcement Row (Law 360-$) (FDA Law Blog)
  • Chelsea's Data on Fainting Drug Is Inadequate, FDA Says (Bloomberg) (Reuters)
  • MannKind Announces Tentative Date of FDA Advisory Committee Review of AFREZZA (Press)
  • EPA Taps Stemina to Screen Drugs for Possible Birth Defects (Xconomy)
  • On Overwarning (D&D Law)
  • Amag's roller coaster ride continues after latest iron deficiency drug news (BioFlash)
  • Meetings: National Vaccine Advisory Committee (DHHS)

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

US: Pharmaceuticals and Biotechnology: General

  • Newly published survey shows drug shortages still have major impact on patient care (Press)
  • ObamaCare expands to cover preventive breast cancer drugs (The Hill)
  • NCPA survey: Drugs often don't make it to patients' hands due to efforts to combat prescription drug abuse (DSN)

US: Medical Devices

  • Google X Staff Meet With FDA Pointing Toward New Device (Bloomberg)
  • FDA approves first gel for sealing corneal incision after cataract surgery (FDA) (Press) (Mass Device)
  • Nature: FDA must clarify how it intends to enforce device regulation on direct-to-consumer (DTC) genome testing services (Nature)
  • Setting the Bar for Blood Glucose Meter Performance (FDA)
  • October 2013 PMA Approvals (FDA)
  • September 2013 PMA Approvals (FDA)
  • Covidien, Puritan Bennett 840 Series Ventilator - Software Problem (FDA)

US: Dietary Supplements

  • GMPs, NDIs and liquid supplements among prominent regulatory concerns for 2014 (NI-USA)

US: Assorted And Government

  • Appropriators Poised To Give FDA $85 Million In Sequestered User Fees (IHP-$)
  • Legislator Asks Appropriators To Assist FDA Access Sequestered User Fees (Lance)
  • Senate Passes Veterinary Medicine Mobility Act (Senate)
  • FDA Enforcement Report - Week of January 8, 2014 (FDA)
  • CMS: Textbooks and Reprints Do Not Fall Under Sunshine Act Statutory Exclusion (CHC)

Upcoming Meetings And Events

  • 10 January 2013: National Biodefense Science Board Meeting (DHHS)
  • 28-29 January 2013: Workshop - Strategies to Address Hemolytic Complications of Immune Globulin Infusions (FDA)
  • 2014 FDA OAGS Small Business Outreach Vendor Fair (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • EU panel recommends suspension of Servier's risky bone disease drug Protelos (Reuters) (EMA)
  • EU extends electronic equipment critical substances time limit (Clinica-$)
  • TAVI: Direct Flow lands EU win, closes U.S. study of aortic valve (Mass Device)
  • Joint MHLW/EMA reflection paper on the development of block copolymer micelle medicinal products (EMA)
  • BioCardia Receives CE Mark for New Helix Transendocardial Delivery Catheter (Press)

Asia

  • More Than 30% Sterile Drug Producers In China Fail To Meet GMP Deadline (PharmAsia-$)
  • Diflucan snagged as China tightens imported drug oversight (SCRIP-$)
  • China High Court Says Celebrities Liable For Endorsements In Drug Ads (PharmAsia-$)

Other International

  • Brazil ANVISA public meeting on drug serialization, tracking system set (TraceLink)

General Regulatory And Interesting Articles

Regulatory Reconnaissance #233 - 10 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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