Regulatory Focus™ > News Articles > Regulatory Reconnaissance (24 September 2013)

Regulatory Reconnaissance (24 September 2013)

Posted 24 September 2013 | By Alexander Gaffney, RAC

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Tips? Gripes? Let me know:

Note: Your news editor is at the AdvaMed 2013 conference through Wednesday, 26 September 2013. Regular news coverage will resume on Thursday.

In Focus: US

In Focus: International

  • MHRA names Hudson as new chief executive (BioCentury)
  • Not so simple: latest ENVI proposals reveal complex management and oversight structure (Clinica) ($)
  • As Indian drug firms squirm under glare, DCGI looks abroad for best practices (Business Standard) (Fierce)
  • DCGI may look into fresh quality complaints against Ranbaxy (PharmaBiz)
  • Canada approves Bayer's riociguat for CTEPH (BioCentury) (DD&D) (Bayer)

Comments? Suggestions? Email me at

US: Pharmaceuticals/Biotechnology

  • FDA's 2013 approvals record falls short of 2012 pace (Fierce) (DD&D)
  • FDA grants Roche ALK inhibitor alectinib breakthrough status (SCRIP) ($) (BioCentury) (Fierce)
  • FDA rejects Merck muscle relaxant drug once again (PMLive) (SCRIP) ($)
  • FDA requiring color changes to Duragesic (fentanyl) pain patches to aid safety―emphasizing that accidental exposure to used patches can cause death (FDA) (Reuters) (MedPage Today) (FDA) (FDA)
  • Pfizer, GSK, Sanofi, Others Take Issue with FDA's CMO Draft Guidance (Outsourcing Pharma)
  • When Will FDA Finally Decide on Safety Guidelines for Acetaminophen, Including Tylenol? (ProPublica)
  • Why Drug Companies Can't Tell The FDA About Every Research Project (Forbes)
  • Drug manufacturing's innovation problem and the regulatory barriers to change (Harvard)
  • USFDA increases inspections of drug facilities in India (India Times)
  • FDA May Ask Sponsors to Repeat Drug-Drug Interaction Studies Reported In Literature (Pink Sheet) ($)
  • The press-release conviction of a biotech CEO and its impact on scientific research (Washington Post)
  • Americans Want More Oversight Of Compound Pharmacies: Survey (Pharmalot)
  • Easy Come, Easy Go? A Viagra Overdose And An Amputated Penis (Pharmalot)
  • Personalized Medicine and Responsible Access to Pain Medication (CMPI)
  • FDA grants Janssen/J&J drug Stelara OK in psoriatic arthritis (SCRIP) ($)
  • Perrigo Announces FDA Final Approval For Generic Version Of Nitrolingual Spray, 400 mcg/spray (Perrigo) (DSN)
  • Boehringer Ingelheim's Empagliflozin Impresses in Pooled Analysis (BI) 
  • Teva Preserves Azilect's Patent Even After FDA Rejects Indication (Pink Sheet) ($) (Teva)
  • 'Reassuring' findings released in national study of influenza vaccine safety in pregnancy (EurekAlert)
  • Alexion reports asfotase alfa Phase II data (BioCentury)
  • Cardiome says intravenous heart drug faster than oral rivals (Reuters)

US: Medical Devices

  • FDA issues final guidance on mobile medical apps (Guidance) (FDA) (Mass Device) (NYTimes) (FDA) (FDA) (Reuters) (MobiHealthNews) (GovHealthIT)
  • Edwards Lifesciences lands expanded approval for Sapien heart valve (FDA) (Mass Device) (Fierce) (Forbes)
  • Deloitte report: Device makers and hospitals have a lot of holes to patch in the data network (MedCity News)
  • Mobile Medical Apps Among Top Issues On FTC's Enforcement Agenda (IHP) ($)
  • FDA expands clearance for Intuitive Surgical's FireFly imaging system (Mass Device)
  • B. Braun Receives FDA Approval For New Large-Volume Irrigation Containers (B.Braun)
  • Luminex Corporation Receives FDA and European Clearance for a New Personalized Medicine Genotyping Assay, xTAG® CYP2C19 Kit (Luminex)

US: Assorted And Government

  • Shutdown Would Result in Furlough of Majority of FDA Staff (IHP) ($)
  • Warning of potential side effects of a product can increase its sales (EurekAlert)
  • There's much less time to avoid a government shutdown than you think (Washington Post) (NYTimes)
  • Murky HIPAA Marketing Guidance Creates Calculation Headache (Law 360) ($)
  • NIH publishes draft policy on genomic data sharing (BioCentury)
  • Foundation to provide open access to blood cancer research data (Reuters)

Upcoming Meetings And Events

  • 24 September 2013: Public Meeting on Narcolepsy Patient-Focused Drug Development (FDA)
  • 25-26 September 2013: ENVI Meeting on Medical Device Proposals (ENVI)
  • 25-26 September 2013: FDA Small Business Regulatory Education for Industry Conference (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)


  • MHRA names Hudson as new chief executive (BioCentury)
  • Not so simple: latest ENVI proposals reveal complex management and oversight structure (Clinica) ($)
  • Bristol-Myers, AstraZeneca recall 92K vials of Bydureon from EU (Fierce)
  • BEUC supporting EMA in data-release case (Pharma Times)
  • GSK receives marketing authorisation from the European Commission for additional Revolade™ (eltrombopag) indication (GSK)
  • EC approves Ultibro for COPD (BioCentury)
  • Roche's subcutaneous Herceptin injection approved for use in UK (Pharma Letter)
  • Tyber Medical Gets CE Mark for Spinal Fusion System (MedGadget)


  • As Indian drug firms squirm under glare, DCGI looks abroad for best practices (Business Standard) (Fierce)
  • DCGI may look into fresh quality complaints against Ranbaxy (PharmaBiz)
  • Daiichi to cooperate with USFDA to resolve Ranbaxy concerns (India Times)
  • Japan, U.S. Said To Propose Split Drug Patent-Term Plan At TPP Talks (PharmAsia) ($)
  • Announcement of the 1st AHWP-RAPS Joint Conference on 2nd-5th Dec 2013 in Malaysia (AHWP)
  • India asks pharma to provide unhindered supply of drugs (BioSpectrum)
  • Thailand Presses EU For Help In Developing Quality Pharma Industry (PharmAsia) ($)

Other International

Regulatory Reconnaissance #162 - 24 September 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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