Regulatory Reconnaissance (27 June 2013)

Posted 27 June 2013 | By Alexander Gaffney, RAC 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

In Focus: International

  • EU Approves Vivus' Erectile Dysfunction Drug Spedra (Pharma Times) (Pharma Letter)
  • MHRA Moves to Ban Marketing of HES Solutions Made by Fresenius Kabi, B Braun (MHRA) (MHRA)
  • MHRA Nets UK Record £12.2 Million Haul of Counterfeit and Unlicensed Medicines (MHRA) (Pharma Times)
  • First Clinical Trial with Induced Pluripotent Stem Cells Grows Closer (Science Magazine) (SCRIP)
  • US Sign-Up Averts Major EU Crisis, but Indian and Chinese APIs Still Problematic (SCRIP)
  • Indian Health Ministry Bans Two Drugs Analgin and Pioglitazone; Industry Protests (India Times) (PharmAsia)
  • Australia, New Zealand Launch Joint Adverse Event Notifications System (JAENS) (ANZTPA)

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  • Sprout Pharmaceutical Resubmits Application for 'Female Viagra' (PR Newswire) (Pharma Times) (MedCity News)
  • Rx Firms Still Bear Promotional Compliance Burden If Social Media Platform Changes, FDA Says (Pink Sheet)
  • FDA Updates its Review Designation Policy for Priority and Standard Reviews (FDA)
  • Roche, AstraZeneca launch drug design consortium (BioCentury)
  • Cardiovascular and Renal Drugs Advisory committee to discuss Bayer's riociguat  (FDA) (BioCentury)
  • FDA Chides Company for Marketing Food Product Using Pharmaceutical Claims (FDA)
  • FDA Releases Approval History Records for Botulism Antitoxin Approved Under Animal Rule (FDA)
  • FDA Attempts To Shutter A Compounding Pharmacy For Good (Pharmalot)
  • FDA Granted Fast Track Designation for Genervon's Breakthrough Biotechnology Multi-Target ALS Drug (Genervon)
  • Alexion's Soliris Given Orphan Drug Designation by FDA (MarketWatch)
  • Planned FDA review of QRxPharma's MoxDuo delayed to allow assessment of new data (Pharma Letter)
  • Investigational and Off-Label - Not the Same Thing (Drug and Device Law)
  • FDA approves Astellas drug for fungal infections in children (DSN)
  • QRxPharma expects delay for MoxDuo review (BioCentury)
  • Valneva wants short-term travel, too, for JE vaccine Ixiaro (SCRIP)
  • Novartis drug helps get rid of the itch and the hives for chronic sufferers (Reuters)
  • Availability of CVM Internal Terms for Use in Veterinary Adverse Event Reporting (FDA)
  • Forest Laboratories Announces Positive Phase III Study Results for Nebivolol and Valsartan Combination in Hypertension (Forest)
  • Experimental type 1 diabetes vaccine shows potential in early study (Reuters) (Bloomberg)
  • AbbVie Gets Humira Patent Invalidated As Obvious (Law 360)
Pharmaceuticals: General
  • Federal District Court Strikes Blow Against RICO Challenges to Drug Co-pay Coupons (FDA Law Blog)
  • More than half of patients with terminal lung cancer thought radiation therapy was cure, not care (Reuters)
  • 'Non-Inferior' Doesn't Mean 'Me-Too' -- Except When It Does (Forbes)
  • Legislation Would Raise Part D Premiums on Wealthy Beneficiaries (Congress)
Medical Devices
  • Everything You Need to Know about UDIs (MDDI)
  • FDA Form 483 Sent to Intuitive Surgical, Manufacturer of the da Vinci Robotics System (FDA) (Mass Device) (Fierce)
  • Chinese Firm Caught Marketing Product Without Approved PMA/510(k) (FDA)
  • NJ Firm Gets Warning Letter for Not Obtaining PMA/510(k) for Device (FDA)
  • Bard's investors shrug off use of potentially dangerous plastic in implants (EP Vantage)
  • FDA approves new streamlined workflow option for Roche's cobas HPV Test (Roche)
  • Johnson and Johnson brings first personalized knee implants to market (Beaker's Blog)
  • April 2013 PMA Approvals (FDA)
  • Medtronic Recalls Infusion Pump Linked to 14 Deaths (Mass Device) (Bloomberg)
  • Weight loss: EnteroMedics submits Maestro nerve-blocking implant for FDA review (Mass Device)
  • Scientific Information Request on Imaging Tests for the Staging of Colorectal Cancer (AHRQ)
  • FDA gives go ahead on new skin pigmentation treatment (Cosmetics Design)
Assorted And Government
Upcoming Meetings And Events
  • 24 June 2013: Science Board Meeting (FDA)
  • 25 June 2013: Meeting Of The National Biodefense Science Board (Dhhs)
  • 25-26 June 2013: Standardizing And Evaluating Risk Evaluation And Mitigation Strategies (FDA)
  • 26 June 2013: General And Plastic Surgery Devices Panel Of The Medical Devices Meeting (FDA) (Materials)
  • 27 July 2013: Gastroenterology And Urology Devices Panel Of The Medical Devices Advisory Committee Meeting (FDA) (Materials)
  • 27 June 2013: Mobile Medical App Entrepreneurs: Changing The Face Of Health Care (House)
  • 27 June 2013: A Tangle Of Trade Barriers: How India's Industrial Policy Is Hurting U.S. Companies (House)
  • 29 June 2013: Clinical Development Programs For Opioid Conversion (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)


  • EU approves Vivus' erectile dysfunction drug Spedra (Pharma Times) (Pharma Letter)
  • MHRA Moves to Ban Marketing of HES Solutions Made by Fresenius Kabi, B Braun (MHRA) (MHRA)
  • MHRA nets UK record £12.2 million haul of counterfeit and unlicensed medicines (MHRA) (Pharma Times)
  • MHRA considers inspecting specials firms; Temag defends itself (RPS)
  • bioMérieux VIDAS 3 Immunoassay Platform Receives CE Mark (MedGadget)
  • Novartis' omalizumab on track for filing in serious skin disease (PMLive)
  • Combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products (EMA) (EMA)
  • EUCERD Recommendations On Core Indicators For Rare Disease National  Plans/Strategies (EUCERD) (2)


  • First Clinical Trial With Induced Pluripotent Stem Cells Grows Closer (Science Magazine) (SCRIP)
  • US sign-up averts major EU crisis, but India, China APIs still problematic (SCRIP)
  • Indian Health ministry bans two drugs Analgin and Pioglitazone; industry protests (India Times) (PharmAsia)
  • Clinical trial industry asks DCGI to be more responsive & proactive towards industry issues (PharmaBiz)
  • China Making Strides On Counterfeit Drugs; Offers Reward For Information, Works With US FDA On Enforcement (Safe Medicines)
  • South Korea Discusses Opening State-owned Pharma For Stable Drug Supply (PharmAsia)

Other International

  • Australia's Medical device reforms fact sheet (TGA)
  • Australia, New Zealand Launch Joint Adverse Event Notifications System (JAENS) (ANZTPA)
  • Medtronic Issues Recall for its Infuse/LT-Cage Bone Graft Kit Due to Abnormally High Levels of Endotoxin (TGA)

General Regulatory And Interesting Articles

  • Counterfeit Food More Widespread Than Suspected (NYTimes)
  • Ayogo is building an adherence game for big pharma (MobiHealth News)

Regulatory Reconnaissance #97 - 27 June 2013

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

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