Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Weekend Edition (19-20 October 2013)

Regulatory Reconnaissance: Weekend Edition (19-20 October 2013)

Posted 18 October 2013 | By Alexander Gaffney, RAC

Welcome to a special weekend edition of Regulatory Reconnaissance, Focus' regulatory news and intelligence briefing.

US: Pharmaceuticals/Biotechnology

  • U.S. FDA panel backs Paladin Labs' parasitic disease drug (Reuters)
  • Securing sterility leads to union headache for Genzyme (Biopharma Reporter)
  • CBER Processing of PDUFA Payment Information (FDA)
  • Op-Ed: For Each Day Of The Shutdown, FDA Lost Two Days (Pharmalot)
  • IPEC and a Broader Coalition of Industry Associations Identify ICH Q3D Implementation Challenges and What is Needed to Meet Them (IPQ-$)
  • On FDA and Label Formatting of Warnings (Drug and Device Law)
  • Selling amphetamine emblazoned athletic shirts v overselling amphetamines: a tale of two entrepreneurs (BMJ)
  • Antimicrobial resistance: what is pharma doing? (SCRIP-$)
  • FDA: Ketoconazole Not Safe for Drug Interaction Studies (DD&D)

US: Medical Devices

  • Class 1 Recall: Bard LifeStent Solo Vascular Stent - Failure to Deploy Stent (FDA)

US: Dietary Supplements

  • Integrated data systems help cut cost of GMP compliance, providers say (Nutra Ingredients)
  • Incoherent and uncoordinated regulators should worry policy makers and industry (Nutra-Ingredients)

US: Assorted And Government

  • OIRA Spending Falls as Agency Spending Swells (Mercatus)
  • A guide to being appropriately neurotic about exchange glitches and enrollment (TIE)

Upcoming Meetings And Events

  • 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)


  • Uncertainty reigns over new EU Regulation's impact, survey finds (Clinica-$)
  • Concept paper on the revision of the note for guidance on the approach towards harmonisation of withdrawal periods (EMA)
  • Draft reflection paper on injection site residues: considerations for risk assessment and residue surveillance (Rev.1) (EMA)
  • Draft guideline on the conduct of efficacy studies for intramammary products for use in cattle (EMA)
  • New Chair of the British Pharmacopoeia Commission (UK)


  • 1M fake Xanax pills intercepted on their way to Egypt from China (Fierce) (Reuters)
  • Vaccine ban worsening Pakistan's polio outbreak (Reuters)

General Regulatory And Interesting Articles

  • MD Anderson Taps IBM Watson to Power "Moon Shots" Mission Aimed at Ending Cancer, Starting with Leukemia (IBM)
  • Scientists create new method to grow 3-D mini artificial pancreas to fight diabetes (MedCity News)

Regulatory Reconnaissance #182 - 19-20 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.

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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