Regulatory Focus™ > News Articles > Regulatory Reconnaissance (17 October 2013)

Regulatory Reconnaissance (17 October 2013)

Posted 17 October 2013 | 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:

In Focus: US

In Focus: International

  • British drug regulator recalls five Wockhardt drugs (Reuters)
  • HTAs need trial data on current drugs to do a proper job, EMA told (SCRIP-$)
  • 577 clinical trial sites inspected in India, Nearly Half Receive Notices (BioSpectrum) (PharmaBiz)
  • Out-of-Pocket Costs as Side Effects (NEJM)

US: Pharmaceuticals/Biotechnology

  • FDA panel votes against expanding Amarin's Vascepa (Pharma Times) (Pharma Letter-$) (Forbes) (Pink Sheet-$) (SCRIP-$) (Reuters) (Pharmalot) (Fierce) (BioCentury) (The Street) (Amarin)
  • Dear FDA, Be Reasonable (And Please Define The Word 'Reasonable') (Pharmalot)
  • Repairing the U.S. Cancer Care Delivery System: Should It Include a New Exclusivity Incentive? (FDA Law Blog)
  • FDA Advises Against Use of J&J's Antifungal Nizoral In Studies (Law 360-$)
  • FDA committees to discuss Lemtrada, tasimelteon (BioCentury) (Vanda)
  • AstraZeneca, Amgen Crohn's drug runs into PhII 'logistical' snafu (Fierce)
  • AMAG Pharmaceuticals Receives Notice of 3-month Extension of the PDUFA Action Date for the Supplemental New Drug Application for Feraheme(R) for the Broader IDA Indication (Press)
  • FDA postpones cell therapy meetings (BioCentury)
  • MiMedx Meeting With FDA Postponed Due To Partial Government Shutdown (MiMedx)
  • Paladin's Impavido Review Documents Released in Advance of Advisory Committee (Pink Sheet-$) (BioCentury)
  • Actelion sales rise ahead of anticipated drug approval (Reuters)
  • Korea's Celltrion Move For Remsima Bridging Trial In Germany Seen As Flight Path To U.S. 2014 FDA Filing (PharmAsia-$)
  • AstraZeneca, Harvard partner to advance 'Organs-on-Chips' drug-testing tech (Fierce)
  • New Weight Loss Drugs, More Rigorous Standards (MedCity News)

US: Pharmaceuticals and Biotechnology: General

  • Doctors to resist uptake of biosimilar insulins: report (MM&M)

US: Medical Devices

  • Fees for 2014 MDUFA Applications Have Been Set (FDA)
  • Medtronic can't shake negligence lawsuit over Transvene defibrillator lead (Mass Device)
  • FDA warns Medtronic over Paradigm insulin pump quality problems (Fierce)
  • Avance, Aisys And Avance CS2 Anesthesia Delivery Systems: Voluntary Field Corrective Action - Potential Safety Issue (FDA)
  • Engström Ventilator, Aespire View, Aisys, And Avance Anesthesia Machines: Voluntary Field Corrective Action - Potential Safety Issue (FDA) (FDA)

US: Dietary Supplements

  • USPLabs gets warning letter for Oxy Elite Pro and VERSA-1, but claims aegeline ingredient has a long history of safe use (Nutra Ingredients) (Letter)
  • NAD Asks Supplement Maker To Ax Clinical Claims (Law 360-$)

US: Assorted And Government

  • Why a Continuing Resolution is Bad for the FDA (Politico)
  • Managing regulatory and legal risk in the digital world: Meeting the challenge in the life sciences industry (EY) (PDF)
  • The Government Shutdown Is Over, but the Damage to Science Will Last (Scientific American)
  • OFR's Refusal to Regulate References (RegBlog)

Upcoming Meetings And Events

  • 16 October 2013: Brookings Roundtable on Active Medical Product Surveillance (FDA)
  • 16 October 2013: Endocrinologic and Metabolic Drugs Advisory Committee Meeting (FDA)
  • 17-18 October 2013: Anti-Infective Drugs Advisory Committee Meeting (FDA) (Day 2)
  • 22-23 October 2013: Cellular, Tissue and Gene Therapies Advisory Committee Meeting (FDA) (POSTPONED)
  • 24-25 October 2013: Antiviral Drugs Advisory Commitee Meeting (FDA) (Day 2)
  • 2-3 December 2013: AHWP/RAPS Joint Conference in Malasia (RAPS)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)


  • British drug regulator recalls five Wockhardt drugs (Reuters)
  • HTAs need trial data on current drugs to do a proper job, EMA told (SCRIP-$)
  • Workshop on clinical investigation of new medicines for the treatment of multiple sclerosis takes place today (EMA)
  • Plug pulled on specialised drugs innovation fund in UK (Pharma Times)
  • Pfizer Receives European Approval For Label Update Regarding The Use Of Prevenar 13 In Certain High-Risk Populations (Press)
  • Scottish value-based assessments "can fix end-of-life treatment problem (SCRIP-$)
  • Dr Reddy's looks to bring biosimilars to EU within five years (Biopharma Reporter)


  • 577 clinical trial sites inspected in India, Nearly Half Receive Notices  (BioSpectrum) (PharmaBiz)

General Regulatory And Interesting Articles

  • Out-of-Pocket Costs as Side Effects (NEJM)
  • Prions May Develop Drug Resistance: The Implications for Mad Cow, Alzheimer's and Parkinson's (Scientific American)
  • Don't Forget About A Prescribing Physician's Failure To Read Warnings (Drug and Device Law)

Regulatory Reconnaissance #180 - 17 October 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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