Regulatory Focus™ > News Articles > Regulatory Reconnaissance (28 March 2013)

Regulatory Reconnaissance (28 March 2013)

Posted 28 March 2013 | By Alexander Gaffney, RAC

Good morning and welcome to another edition of Regulatory Reconnaissance.

In the US, FDA accepts an application from Merck for a new grass allergy tablet, a cardiologist gets sentenced to six year in jail for Fen-Phen fraud, India's Aurobindo gets removed from an import alert, BD gets approval for a new injectable antihistamine, Massachussetts considers several new laws on compounding and prescribing, FDA provides an update on pre-filled glass syringes, Medtronic could face many more lawsuits over its Infuse device, Medicare stops reimbursing diagnostic tests, and FDA posts new warning letters and its weekly enforcement report.

Abroad, EMA's new fee schedule comes into effect on Monday, EMA closes its doors for the Easter holiday, Pfizer's bosutinib gets EC approval even as one of its cancer drugs gets the cold shoulder from NICE, MHRA sentences four for counterfeiting, France's ANSM gets a new board member, India's industry wants clarification on fixed-dosage combinations, and Japan considers new OTC drug rules.

Five in Focus:

  1. Increased fees coming into effect on 1 April 2013 (EMA)
  2. FDA to review grass allergy tablet (BioCentury) (Drug Discovery & Development) (Merck)
  3. India's Aurobindo Pharma Removed From U.S. FDA Import Alert (PharmAsia News) ($) (Economic Times)
  4. FDA Update on Pre-Filled Glass Syringes (FDA)
  5. Pfizer gets new rebuff from UK cost body for cancer drug (Reuters)


Medical Devices
  • FDA Update on Pre-Filled Glass Syringes (FDA)
  • pSivida takes another stab at FDA approval for Iluvien (Mass Device)
  • Lawyer foresees 100s more claims against Medtronic in Infuse lawsuits (Mass Device)
  • Bioheart to ask FDA for "compassionate use" permit for cardiac stem cell therapies (Mass Device)
  • Next-gen prostate cancer Dx faces skepticism, competition (Fierce Medical Devices)
  • BioControl expands IDE study for heart failure treatment device (Fierce Medical Devices)
  • Medicare Has Stopped Paying Bills For Medical Diagnostic Tests. Patients Will Feel The Effects (Forbes)
  • Recall (Class I): Spacelabs Medical, Inc., Spacelabs Anesthesia Workstations and Service Kits (FDA) (FDA) (Mass Device)
  • Recall (Class I): Vascular Solutions Inc's Guardian II and Guardian II NC Hemostasis Valves (FDA)
  • Transcript of Neurological Devices Panel Meeting on the NeuroPace RNS System Epilepsy Device (FDA)
  • Enforcement Report - Week of March 27, 2013 (FDA)
  • ACRO Calls for Clarity on FDA Draft Guidance on eSource Trial Data (Outsourcing Pharma)
  • Social Media Guidelines: In Pursuit of a Policy (PharmExec)
  • When A Famous Hospital Didn't Want An Expensive New Drug (NPR)
  • Blessed by Gates, crowdfunding site funnels cash for high-risk R&D (Fierce Biotech)
  • The Two Big (Regulatory) Developments That Are Boosting Pharma Stocks (Forbes)
  • DEA targets FedEx, UPS in online-pharmacy probe (Med City News)
  • OIG Promotes Compliance Training for Health Care Boards of Directors (OIG)
  • US sub-registry seeks to boost autism research participation (Pharma Times)
  • Pilot quality-by-design study published in Drug Information Journal (CTTI)
Warning Letters
  • (Medical Device) Instratek Inc for CGMP, CAPA, Control Procedures (FDA)
  • (Medical Device) Fisioline s.r.l. for CGMP, MDR (FDA)
  • (Medical Device) Hyphen BioMed for QSR, CGMP, CAPA (FDA)
  • (Dietary Supplement) USA Far Ocean Group Inc for Tainted Supplements, Unapproved Drugs, Improper Claims, Misbranding (FDA)
Government and Budget
Meetings This Week
  • 25 March 2013: FDA Webinar on Draft Guidance for Industry on Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products (FDA)
  • 25 March 25: Webinar Draft GFI On Enrichment Strategies For Clinical Trials To Support Approval Of Human Drugs And Biological Products (FDA)
  • 27-28 March 2013: Public Meeting on the Food Safety Modernization Act (FSMA) (FDA)
  • 28 March 2013: Webinar: Draft Guidance For Industry On Alzheimer's Disease: Developing Drugs For The Treatment Of Early Stage Disease (FDA)


  • Increased fees coming into effect on 1 April 2013 (EMA)
  • Reflection paper on Immune Tolerance Induction in haemophilia A patients with inhibitors (EMA)
  • European Medicines Agency closed 28 March - 1 April 2013 (EMA)
  • Ten pharma firms censured (Pharmafile)
  • Bernadette Devictor appointed to the Board of Directors of the ANSM (ANSM)
  • Pfizer's BOSULIF (bosutinib) Receives Conditional Marketing Authorization From The European Commission (Pfizer)
  • Three men and one woman sentenced in counterfeit medicines case (MHRA)
  • Japan Cabinet Task Force To Consider New On-Line OTC Drug Rules (PharmAsia News) ($)
  • India's Industry Seeks Clarification Regarding Regulatory Status of Fixed Drug Combinations (PharmaBiz)
  • Pfizer gets new rebuff from UK cost body for cancer drug (Reuters)
  • EUnetHTA facilitates joint response to the public consultation on PAES (EUnetHTA)
  • European Medicines Agency workshop on multiplicity issues in clinical trials (EMA)
  • MHRA Releases Learning Module on Benzodiazepines (MHRA)

General Regulatory and Interesting Articles

  • Commonly used cholesterol calculation underestimates heart disease danger for many (EurekAlert)
  • Devices Coated with Paclitaxel Help Leg Arteries (Med Page Today)
  • The Dawn of Genome Trolling (MIT Technology Review)
  • Do intellectual property rights on existing technologies hinder subsequent innovation? (EurekAlert)

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 or @AlecGaffney 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.

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