Regulatory Focus™ > News Articles > Regulatory Reconnaissance (20 August 2013)

Regulatory Reconnaissance (20 August 2013)

Posted 20 August 2013 | By Alexander Gaffney, RAC

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

In Focus: US

In Focus: International

  • Is the regulatory world ready for "nanosimilars"? (SCRIP)
  • India's Ambassador Hits Back at Claims His Country Doesn't Support Pharmaceutical Innovation (The Hill)
  • Japan Announces Schedule For Pharmaceutical Act Revision Proposal (PharmAsia)
  • India: DCGI's plan to establish drug audit office in China yet to come up (PharmaBiz)
  • Colombian regulators simplify translation, grouping rules for medical device registration (Mass Device)

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  • Eisai sues DEA over Fycompa scheduling (PMLive) (Pharma Letter) (Law 360) (BioCentury) (Fierce) (Pink Sheet)
  • Novartis muscle wasting drug gets 'breakthrough' status (Reuters) (PMLive) (Fierce)
  • Selling Sentinel: FDA Highlights Vision For Broader Role For Data Network At Brookings (RPM Report)
  • Industry Coalition Takes Off-Label Speech Concerns To CDER's Policy Council (IHP)
  • FTC Seeks to File (Again) Amicus Brief in EFFEXOR XR "No-AG" Agreement Antitrust Case; Plaintiffs in Similar LAMICTAL Case Seek Reconsideration of Dismissal (FDA Law Blog)
  • Global Supply Chain Highlighted in FDA Public Meeting Discussing FDASIA's Title VII (FDA Lawyers Blog)
  • Is The FDA the Problem? Probably Not (In the Pipeline)
  • Alnylam Receives Additional Orphan Drug Designation from U.S. Food & Drug Administration for ALN-AT3, an RNAi Therapeutic for the Treatment of Hemophilia (Alnylam)
  • Supernus shares jump after US FDA nod for epilepsy drug (Pharma Letter) (DSN) (SCRIP)
  • J&J: We Achieved A 'Major Milestone' At Our Troubled OTC Plant (Pharmalot)
  • GTx muscle drug fails late-stage trials, shares plunge (Reuters) (GTx) (Fierce) (BioCentury) (SCRIP) (Pink Sheet) (Bloomberg)
  • No settlement: Trial begins for Lilly's cancer drug Alimta, vitamin dosing patent (SCRIP)
  • Upsher-Smith gets 'tentative' OK from FDA for testosterone gel (SCRIP)
  • FDA AdComm to Assess Amarin's Vascepa on 16 October 2013 (FDA)
  • Determination That Lidex and Nine Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness (FDA)
Pharmaceuticals: General
  • Billy Tauzin Rides Again, This Time Battling Against Big Pharma (Huffington Post)
  • A Dry Pipeline for Psychiatric Drugs (NYTimes)
  • Brain cancer survival improved following FDA approval of bevacizumab, Mayo study finds (EurekAlert)
  • Oklahoma Judge Blocks Law Limiting Morning-After Birth Control (NYTimes)
Medical Devices
  • Device maker Covidien recalls flush syringes with non-sterilized water (MedCity News) (Fierce)
  • Lawmakers Press OMB To Release Lab-Developed Test Draft Guidance (Pink Sheet)
  • Whatever Became of that LDT Regulation? (MDDI)
  • Updated List of PMA Summaries Released by FDA (FDA)
  • AngioDynamics Earns FDA Clearance for Ports With BioFlo Technology to Reduce Catheter-Related Thrombus (AngioDynamics)
  • CoAlign Innovations, Inc. Announces FDA Clearance of AccuLIF Expandable Interbody Device Product Line for Lateral Surgical Approaches (CoAlign)
  • ITC Launches New Patent Probe Of Sleep Aid Devices (Law 360)
  • Becton Can't Dodge Rival Syringe Maker's Antitrust Claims (Law 360)
Assorted And Government
  • Challenge foreseen to FDA's exclusion of medical foods for diabetics (Nutra Ingredients)
  • AHRQ Names Kronick as New Director (Medpage Today)
  • Physician Payment Sunshine Act: CMS Releases User Guide for Industry (Policy and Medicine)
  • Roundup of Dietary Supplement Regulatory Issues (NPI)
  • Herbal Give Care LLC Issues Voluntary Nationwide Recall of Capsules/Vitamin Supplements Due to Potential Health Risks (FDA)
Upcoming Meetings And Events
  • 19 August 2013: FDA Basics Webinar: Biological Products, Part 2: Biosimilar Biological Products (FDA)
  • 26 August 2013: WMA Declaration of Helsinki Meeting (WMA)
  • 4-5 September 2013: Public Workshop on the Trial Designs and Endpoints for Liver Disease Secondary to Nonalcoholic Fatty Liver Disease (FDA)
  • 24 September 2013: Public Meeting on Narcolepsy Patient-Focused Drug Development (FDA)
  • 25-26 September 2013: FDA Small Business Regulatory Education for Industry Conference (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)


  • Roche's new skin cancer drug now available in UK (Pharma Times)


  • Japan Announces Schedule For Pharmaceutical Act Revision Proposal (PharmAsia)
  • India's Ambassador Hits Back at Claims His Country Doesn't Support Pharmaceutical Innovation (The Hill)
  • India: DCGI's plan to establish drug audit office in China yet to come up (PharmaBiz)
  • India to investigate safety of pentavalent vaccines (Fierce)
  • Bayer's Stivarga® Approved for the Treatment of Patients with Gastrointestinal Stromal Tumors in Japan (Bayer)
  • Announcement: Location of 18th AHWP Annual Meeting & 1st AHWP-RAPS Joint Conference (AHWP)
  • What Would Fundamental Change To Reimbursement Mean For Multinationals? - China Big Pharma Roundup (PharmAsia)

Other International

  • Colombian regulators simplify translation, grouping rules for medical device registration (Mass Device)

General Regulatory And Interesting Articles

  • Is the regulatory world ready for "nanosimilars"? (SCRIP)
  • Inventor launches crowdfunding hub for medical devices (Fierce)
  • CDC: Lyme disease rates 10 times higher than previously reported (CBS) (NPR)
  • Bat Man Aims for Elixir of Life From Creatures of Night (Bloomberg)

Regulatory Reconnaissance #135  - 20 August 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.

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