Regulatory Focus™ > News Articles > Regulatory Reconnaissance (30 April 2013)

Regulatory Reconnaissance (30 April 2013)

Posted 30 April 2013 | By Alexander Gaffney, RAC

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

In Focus: US

In Focus: International

  • Indian Government Panel Slams CDSCO for Irregularities, Failure to Take Action (PharmaBiz)
  • Recommendation to suspend tetrazepam-containing medicines endorsed by CMDh (EMA)
  • Report That Ousted Former Health Commissioner John Dalli Called 'Biased' and 'Amateurish' (EurActiv)
  • UK Government Defends Itself Against Media Reports About Blood-Borne vCJD (UK)
  • Calls to Improve Uptake of NICE-Approved Treatments for MS (NICE)

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  • FDA's GDUFA Guru Is Named Permanent Head Of Office Of Executive Programs (The Pink Sheet Daily) ($) (DSN)
  • FDA rejects two of the four drugs in Gilead's blockbuster HIV drug Stribild (Fierce Biotech) (The Pharma Letter) (Gilead) (Reuters) (AP) (BioCentury) (FDA News) (SCRIP Intelligence)
  • Mining clinical notes could detect harmful drug reactions earlier (Fierce Biotech IT)
  • New Animal Drugs: Dexmedetomidine, Lasalocid, Melengestrol, Monensin, and Tylosin (FDA)
  • FDA Calls for Comments on Abbreviated New Animal Drug Applications (ANADAs) (FDA)
  • GSK: FDA Needs to Clarify One Point in Recent HCV Guidance (FDA)
  • Ferrlecit Generic To Get 3-Part Evaluation After FDA Worry On Therapeutic Equivalence (The Pink Sheet) ($)
  • Voluntary Nationwide Recall of 15 Lots of Piperacillin and Tazobactam for Injection, USP 40.5 Grams Due to Possibility of Precipitation / Crystallization in IV Bag or IV Line Upon Reconstitution (FDA)
  • Merck Wins Fosamax (alendronate sodium) Federal Trial Involving Femur Fracture Claims (Merck)
  • Merck Escapes Suits Over Prescription Copay Coupons (Law 360) ($)
  • Eli Lilly Says It Warned Doctors Of Cymbalta 'Brain Zaps' (Law 360) ($)
  • FDA Accepts Octapharma USA Biological License Application for octaplex - an Investigational 4-Factor PCC (Business Wire)
  • Man Pleads Guilty to Charges Related to Importing Misbranded Oncology Drugs (FDA)
  • FDA Approves Teva Pharmaceuticals' Levalbuterol Hydrochloride (ANDA # 090297) (FDA)
  • Shire Receives Expanded Approval for its Vyvanse (Lisdexamfetamine Dimesylate) NDA (#021997) (FDA)
  • GSK and Impax end Parkinson's collaboration (PMLive) (Reuters) (FDA News) ($)
  • Lonza API plant problems undermine Ipsen's Increlex supplies (Fierce Pharma Manufacturing)
  • A New Direction for Alzheimer's R&D: FDA Outlines Early Disease Pathway (RPM Report) ($)
  • FDA Updates Veterinary MU/MS List (FDA)
  • US Congress Needs to Establish Firm T&T Timeline, Standards, Stakeholders Say (Outsourcing Pharma)
  • The House Hearing on 'Securing Our Nation's Prescription Drug Supply Chain' (RxTrace)
  • California's Draft Regulation on Inspections (RxTrace)
  • FDA Looking to Acquire Monkeys to Conduct Pharmacological Testing (FDA)
  • "Evergreening": What OxyContin Tells Us About the Value of "Evergreening"and the Patents That Protect It (Biotech Now)
  • Another Preemption Win for Branded and Generic Manufacturers (Drug and Device Law)
Medical Devices
  • After Win, FDA May Backtrack On More Device Approvals (Law 360) ($) (Covington Legal Brief)
  • Letter from Three Members of Congress Presses FDA on UDI Implementation Timeline (Pew)
  • US Army: Subjecting CES Devices to a PMA Process Would Potentially Hurt Soldiers Suffering from PTSD (FDA Docket)
  • AdvaMed to FDA: Proposed Pediatric Use Device Guidance is Almost Perfect (FDA Docket)
  • Sorin to pursue FDA PMA pathway for sutureless aortic valve (Fierce Medical Devices) (Business Wire)
  • Judge tosses Smith & Nephew hip lawsuit (Fierce Medical Devices)
  • Chiropractor and School Charged with Unlawfully Shipping Unapproved Devices (FDA)
  • FDA clears Microline Surgical shears designed for TransEnterix's Spider (Mass Device)
  • FDA clears Lantos Technologies' ear-scanning device (Mass Device)
  • FDA clears ResMed's at-home respiratory assist device (Mass Device)
  • Blockade Medical Announces 510(k) Clearance of the Barricade Coil System and Completion of the First Series of Clinical Cases (Business Wire)
  • FDA clears new fat transfer system for Andrew Technologies' liposuction device (Mass Device)
  • ETView Medical, Ltd. Announces US FDA Clearance of a 510(k) Pre-marketing Notification Application Expanding the VivaSight-DL line of Innovative Airway Devices (Business Wire)
  • Teleflex Receives FDA 510(k) Clearance for Next Generation Vascular Positioning System (Business Wire)
  • ProScope Micro Mobile Turns Any Apple iOS Device into Professional Microscope (MedGadget)
  • NinePoint Medical wins expanded Nvision nod from FDA  (Mass Device)
  • ORA Chief Melinda Plasier's Speech to FDLI Last Week (FDA)
  • Op Ed: Counting Our Blessings with the Office of Combination Products (MDDI)
  • HHS OIG Provider Self Disclosure Protocol (Policy and Medicine)
  • FDA probing caffeinated products, from gum to chips (CBS)
  • Task force calls for routine HIV testing for all adults (Reuters)
  • Patient-Centered Outcomes Research Institute Names Regina Yan Chief Operating Officer (PCORI)
  • Oh, Come On: Pharma Whinges About Government Drug Sales Force (Forbes)
  • GNC gradually dumping DMAA but not because it's unsafe (Nutraingredients USA)
Government and Budget
  • Schumer touts bill to restrict painkillers (The Hill) (Law 360) ($)
  • Rep. Slaughter Blasts CVM's Bernadette Bunham on Antibiotic Resistance (NYTimes) (FDA Response)
  • Obama warns sequestration could hurt scientific innovation (BioCentury)
  • The head of the House Committee on Science does not understand how science works (Scientific American)
Upcoming Meetings and Events
  • 29 April 2013: Accessible Medical Device Labeling in a Standard Content and Format (FDA)
  • 29 April 2013: Meeting of the Risk Communication Advisory Committee (FDA)
  • 29 April 2013: Margaret Hamburg to Appear at Milken Institute Conference on 'The Promise of the Bioscience Century' (Milken)
  • 30 April 2013: Meeting of the Risk Communication Advisory Committee (FDA)
  • 2 May 2013: Meeting of the Oncologic Drugs Advisory Committee (FDA)
  • 2 May 2013: Meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee (FDA)
  • 3 May 2013: Joint Meeting of the Medical Imaging Drugs Advisory Committee and Oncologic Drugs Advisory Committee (FDA)
  • 16 May 2013: OPDP Enfocement Actions Webinar (FDA)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (FDA)


  • Indian Government Panel Slams CDSCO for Irregularities, Failure to Take Action (PharmaBiz)
  • Recommendation to suspend tetrazepam-containing medicines endorsed by CMDh (EMA)
  • Report That Ousted Former Health Commissioner John Dalli Called 'Biased' and 'Amateurish' (EurActiv)
  • Methodology in focus - EUnetHTA guidelines (EU net HTA)
  • Ontario Institute to co-ordinate Canadian Cancer Clinical Trials Network (Pharma Times)
  • Astellas Receives Position CHMP Opinion for Xtandi (Enzalutamide) in Advanced Prostate Cancer (Astellas)
  • UK Government Defends Itself Against Media Reports About Blood-Borne vCJD (UK)
  • European Medicines Agency closed 1 May 2013 (EMA)
  • New Zealand Drug-Maker Report Says Pharmac Too Slow To Cover Drugs (PharmAsia News) ($)
  • Calls to improve uptake of NICE-approved treatments for MS (NICE)
  • Something completely different: a EU medical devices regulation chart (Medical Devices Legal)

General Regulatory and Interesting Articles

  • Frequently used biologic agents might cause acute liver injury (EurekAlert)
  • Drug donations are great, but should Big Pharma be setting the agenda? (The Guardian)
  • We The People vs. The Pharmaceutical Industry (Forbes)
  • Medication errors also happen at home: study (Forbes)
  • Publication bias, not conflicts, may be bigger concern in cancer trial reports (Modern Healthcare)

Regulatory Reconnaissance #56 - 30 April 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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