Regulatory Reconnaissance (6 June 2013)

Posted 06 June 2013 | By Alexander Gaffney, RAC 

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

In Focus: US

In Focus: International

  • Industry Tells MHRA: "Don't Forget UK" (Pharma Times)
  • New Process on Submitting Supplementary Info for Registering Devices in China (Clinica)
  • ANVISA Plans Trial Period for 3rd Party B-GMP Audits (Mass Device)
  • Australia Wants Greater Control Over Drug, Device Ads (SCRIP)
  • Petition Filed in India to Revoke Ranbaxy's Manufacturing License (India Times)

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  • Two-Dose Contraceptive Must Be Made Available to All Ages, but FDA Wins Stay on Single-Dose Version (Bloomberg) (SCOTUS Blog) (Reuters) (AP) (WSJ) (The Hill) (Washington Post) (FDA News) (BioCentury) (NYTimes) (Pharmalot) (SCRIP)
  • FDA panel revisits Avandia diabetes drug (Reuters) (SCRIP) (Pink Sheet) (MedPage Today) (Law 360) (FDA News)
  • U.S. Food and Drug Administration Approves REVLIMID® (lenalidomide) for the Treatment of Patients with Relapsed or Refractory Mantle Cell Lymphoma (Celgene) (FDA) (Reuters) (Pharma Times)
  • Birth control pill latest in string of recalls by Johnson & Johnson (Reuters)
  • Avanir Pharmaceuticals Announces Accelerated Development Path for AVP-786 Following Successful Pre-IND Meeting with FDA (Avanir)
  • FDA Declares that Suboxone Was Not Withdrawn For Safety or Efficacy Reasons, Paving Way for Generics (FDA)
  • FDA Delay on New Drug Triggers Layoffs at San Diego's Zogenix (Xconomy)
  • Regulatory Delays Lead to Layoffs for Impax (Bloomberg)
  • After FDA Denies Testosterone Drug, Endo Announces Layoffs (Endo)
  • Flamel wins FDA nod for Bloxiverz (SCRIP) (Pharma Letter)
  • Generic heartburn drug made by Korean company poised to win FDA approval (DSN)
  • Merck Sues Watson Labs To Block Generic Contraceptive (Law 360)
  • Momenta Urges Justices To Clarify Drug Safe Harbor Rule (Law 360)
  • Peramivir 'stop-work' order extension dents BioCryst (SCRIP)
  • FDA Grants Tentative Approval for Lupin's Generic Pregabalin (FDA)
  • Momenta Spars with Amphastar; Says Federal Circuit's LOVENOX Safe Harbor Decision Must be Taken Up by the Supreme Court (FDA Law Blog)
  • Vertex Plans to Present Interim Results of the First-Ever Breakthrough Designation Product at an Upcoming Meeting (Vertex) (The Street)
  • Bayer: Positive Phase 3 Results for VEGF Trap-Eye (Intravitreal Aflibercept) in Myopic Choroidal Neovascularization (mCNV) (Bayer)
  • Hepatitis C miracles--courtesy of "me-too" drugs (MPT)
  • 15 insurers urged to change specialty drug prescription policies (Fierce)
Medical Devices
  • Lessons from an OrthoTec Innovator: Get FDA and Congress on Your Side (MDDI)
  • When Conduct Becomes a Crime: The Case of Synthes (FDA)
  • Intuitive faces investor lawsuit as da Vinci claims await (Fierce)
  • FDA clears GlobalMed's medical imaging cloud software (Mobi Health News)
  • Cook wins 510(k) status for next-gen biliary stent (Fierce)
  • Abbott posts positive MitraClip results as FDA looms (Fierce)
Assorted and Government
  • FDA's Sequestered User Fees From FY 2013 Likely Gone, But FY 2014 Fees Could Be Exempted (Pink Sheet)
  • FDA's Thomas Abrams (OPDP) on Keeping Drug Advertising Honest and Balanced (FDA)
  • US declares potential emergency over new Middle East virus (NBC)
  • Senate panel to consider Obama's regulatory czar pick (The Hill)
  • Foreign Manufacturers Legal Accountability Act of 2013 (Congress)
  • Judge's ruling enables girl to get life-saving lung transplant (CBS)
  • USPTO Proposes Rules Changes to Implement Patent Law Treaty (Patent Docs)
Upcoming Meetings and Events
  • 3 June 3013: House Energy and Commerce Committee to Vote on Track and Trace, ADUFA/AGDUFA Bills Bill (E&C) (The Hill)
  • 5-6 June 2013: Two-Day Avandia Meeting (FDA)
  • 29 June 2013: Clinical Development Programs for Opioid Conversion (FDA)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (FDA)


  • Industry tells MHRA: "don't forget UK" (Pharma Times)
  • Diabetes: Echo aims for CE Mark with clinical trial of Symphony needle-free CGM (Mass Device)
  • Ferrer's Ozenoxacin shows superiority in Ph III impetigo trial (Pharma Letter)
  • WP5 Strand A - Procedure Manual V3 is now available (EUnetHTA)


  • New process on submitting supplementary info for registering devices in China (Clinica)
  • Approved in India, Cadila plans global launch of "blockbuster" diabetes drug (Reuters) (Pharma Letter)
  • Ranbaxy drugs are 'safe and efficacious': South African regulator (India Times)
  • Petition Filed in India to Revoke Ranbaxy's Manufacturing License (India Times)
  • India High Court Suit Seeks Strong Action Against Ranbaxy, Directors (PharmAsia News)
  • Tolvaptan filed for rare kidney disease in Japan (SCRIP)
  • CDSCO to initiate action against druggists who expose temperature-sensitive drugs to high temperature (PharmaBiz)

Other International

  • ANVISA plans trial period for 3rd Party B-GMP audits (Mass Device)
  • Australia wants greater control over drug, device ads (SCRIP)

General Regulatory and Interesting Articles

  • Decline In Placebo-Controlled Trial Results Suggests New Directions For Comparative Effectiveness Research (Health Affairs)
  • Clinical drug trials in general practice: a 10-year overview of protocols (Trials Journal)
  • Rethinking sources of representative controls for the conduct of case--control studies in minority populations (Medical Research Methodology)
  • Comparison of Treatment Effect Estimates for Pharmacological Randomized Controlled Trials Enrolling Older Adults Only and Those including Adults: A Meta-Epidemiological Study (PLoS)
  • Shortages of Drugs Threaten TB Fight (WSJ)

Regulatory Reconnaissance #82 - 6 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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