Regulatory Focus™ > News Articles > Regulatory Recon: Holiday Weekend Super-Recap (27 May 2014)

Regulatory Recon: Holiday Weekend Super-Recap (27 May 2014)

Posted 27 May 2014 | By Alexander Gaffney, RAC

Regulatory Recon: Holiday Weekend Super-Recap (27 May 2014)

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

US: Pharmaceuticals/Biotechnology

  • FDA approves Durata's antibacterial Dalvance in First GAIN Act Approval (Pharma Times) (Pink Sheet-$) (FDA) (Reuters) (SCRIP-$)
  • Report: FDA to inspect more Sun plants in the next few weeks (Fierce)
  • FDA told to talk before enforcing pharmacy law (The Hill) (Alexander)
  • Wockhardt says FDA inspected US unit in March quarter (India Times) (Reuters)
  • After Years of Waiting, FDA Finally Lets Rip With Prescription PEG 3350 ANDA Withdrawal Proposal (FDA Law Blog)
  • House E&C subcommittee to vote on DEA scheduling bill (BioCentury) (E&C)
  • Woodcock, FDA: Understanding Pharmaceutical Quality by Design (AAPS)
  • 100 year-old rules on API impurities to change in 2015 (In-Pharma)
  • 'Right To Try' Bills Raise New Hurdles For Drug Approvals (Law 360-$)
  • Crucial Challenges For U.S. FDA In China As Medical Trade Booms (PharmAsia-$)
  • Drug Shortage Prevention Could Be Funded Through GDUFA (Pink Sheet-$)
  • Opioid Post-Market Study Faces Recruitment, Efficacy Challenges (Pink Sheet-$)
  • Health Advocates Submit Letter to FDA Regarding Biosimilars Policy and Women's Health (Press)
  • FDA Opioid Policy: Senate Takes A Speak Softly Approach (Pink Sheet-$) (Mikulski)
  • Teva recalls drugs made by India's Emcure over lab testing issues (Fierce)
  • Give Me a M-E-T-R-I-C-S – Go Quality Metrics! (PCM)
  • Teva Receives FDA Approval for QVAR with Dose Counter (PharmPro) (Press)
  • FDA expands label for Amgen's Vectibix (BioCentury) (Press) (SCRIP-$) (Bloomberg)
  • Clinical evaluation of pertussis vaccines: US Food and Drug Administration regulatory considerations. (PubMed)
  • Consumer Reports Sunscreen Complaints Look Cloudy To Trade Groups (Tan Sheet-$)
  • Fresenius recalls hemodialysis liquid after bacteria discovery (Fierce) (FDA)
  • FDA Safety Communication: Product Shortage of Advanced Sterilization Products Sterrad Cyclesure 24 Biological Indicator (FDA)
  • GS1 Ratifies Updated Versions of EPCIS and CBV (RxTrace)
  • Petition Denial to Noven Indicates FDA Stuck on the Same Response (Lachman) (Pink Sheet-$)
  • Where’s Upton? 21st Century Cures Take Temporary Back Seat To The Internet (Pink Sheet-$)
  • A community-engaged approach to quantifying caregiver preferences for the benefits and risks of emerging therapies for duchenne muscular dystrophy. (PubMed)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

  • QRxPharma Receives Complete Response Letter From FDA Regarding Moxduo NDA (Pipeline Review)
  • InterMune Announces Resubmission Of NDA For Pirfenidone For The Treatment Of Patients With IPF (Press)
  • Pfizer psoriasis treatment succeeds in late-stage trial (Reuters) (Press)
  • FDA delays PDUFA for Keryx's Zerenex (BioCentury)
  • Santhera leaps on detailed DMD data (BioCentury)
  • Dainippon Sumitomo Pharma to Stop Trial on New Colon Cancer Drug (PharmPro)
  • Provectus Biopharmaceuticals Inc. Reaffirms Its Commitment to Bringing PV-10 to Market Notwithstanding FDA Decision on Breakthrough Therapy Designation (Press)

US: Pharmaceuticals and Biotechnology: General

  • OIG Promises Scrutiny of Narrowly Focused Patient Assistance Programs Run By Independent Charities - Some Practices Previously Endorsed Are Now Suspect (FDA Law Blog)
  • Drug Repurposing and Repositioning – IOM Workshop Summary (IOM)
  • Tug Of War Over Promising Cancer Drug Candidate (C&EN)
  • Atossa board adopts 'poison pill' remedy in wake of FDA crackdown (Fierce)
  • Patent office backlog adds billions to national drug expenditure (Nature)
  • IV Shortage Hits Rural Clinics Hard (NBC)

US: Medical Devices

  • FDA warns CardiacAssist on unreported patient death (Mass Device)
  • Prostate cancer: EDAP lands FDA date for therapeutic ultrasound (Mass Device) (Gray Sheet-$)
  • FDASIA workshop takes a hard look at risks and safety (mHealthNews)
  • Solicitor General’s Brief in Medical Device Tort Case Capitulates to Plaintiffs’ Bar (WLF)
  • FDA OK's Qiagen companion Dx for use with Amgen colon cancer drug (Fierce) (Reuters) (Press)
  • eNeura receives 510(k) for second-generation migraine treatment device (Fierce) (Mass Device)
  • FDA Designates Four Class I Recalls In Four Days (Gray Sheet-$)
  • FDA warns on infant CPAP systems following dozens of complaints (Mass Device) (FDA)
  • FDA Approves Expansion of BIOTRONIK ProMRI ICD Trial to Include Full-Body Scans and DX Technology (Press) (Mass Device)
  • EkoSonic Endovascular System Receives FDA Clearance for the Treatment of Pulmonary Embolism in the USA (Press)
  • St. Jude touts renal denervation data, but U.S. approval still a long way off (Fierce)
  • Baxter Corporation Englewood, ABACUS Total Parenteral Nutrition Calculation Software, Versions 3.1, 3.0, 2.1, and 2.0 - Software Errors May Cause Toxic or Overdose Symptoms (FDA)
  • Maquet Datascope Corporation, Intra-Aortic Balloon Pumps, System 98/98XT, CS100/CS100i, and CS300 - Potential Failure of Fan Assembly May Cause Pumps to Shut Down Without Any Alarm (FDA)

US: Dietary Supplements

  • Q&A: USP on Monographs for Dietary Supplements (NPI)
  • FSMA’s Role in Supplement Regulation (NPI)

US: Assorted And Government

  • Senate committee to redraft 'patent troll' legislation (BioCentury)
  • PhRMA Issues Statement on Withdrawal of Patent Legislation from Senate Judiciary Committee Agenda (Press)
  • The Real "Tsunami" in Federal Regulatory Policy (CPR)
  • On Conflicts of Interest, Stossel: What, Me Worry? (Medpage Today)
  • FDA sees the light on label-less food marking (Food Quality)


  • Rasi responds to concerns on transparency policy (BioCentury) (Letter) (EMA) (SCRIP-$)
  • CHMP backs European approval for six new medicines (PMLive) (EMA) (SCRIP-$)
  • CHMP Reverses Decision, Endorses PTC's DMD Drug Translarna (Ataluren) (Press) (Pharma Times) (Pink Sheet-$) (Fierce) (The Street) (BioCentury) (Reuters) (EMA) (Xconomy) (SCRIP-$)
  • UK MHRA’s Compliance Management Upgrade Includes “Risk Intelligence IT System” for Drug Inspection Targeting (IPQ-$)
  • CHMP turns down Avastin for brain cancer (PMLive) (Pharma Times)
  • Lilly, Boehringer pick up EU nod for FDA-spurned diabetes treatment (Press) (Fierce) (Fierce) (Pharma Times) (BioCentury)
  • The EU's not impressed with Novartis' 'breakthrough' cardio drug Serelaxin, either (Fierce) (Reuters) (SCRIP-$)
  • Biogen gets CHMP thumbs up for MS drug Plegridy (Pharmafile) (BioCentury)
  • Teva backs laquinimod for MS despite CHMP rejection (PMLIve) (Pharma Times) (Fierce) (MedCityNews)
  • Veloxis says CHMP backs Envarsus (BioCentury)
  • CHMP recommends EU approval of Roche’s Gazyvaro for people with chronic lymphocytic leukemia (Press) (Fierce) (BioCentury) (EMA) (SCRIP-$)
  • Eisai Receives Positive Opinion From EMA's CHMP On Expanding Indication Of Anticancer Agent Halaven For Use In Earlier-Line Treatment Of Advanced Breast Cancer (Press)
  • GSK and Genmab receive CHMP positive opinion for Arzerra (ofatumumab) in combination with chlorambucil or bendamustine as a first-line treatment for patients with chronic lymphocytic leukaemia (CLL) who are not eligible for fludarabine-based therapy (Press)
  • Combined use of medicines affecting the renin-angiotensin system (RAS) to be restricted – CHMP endorses PRAC recommendation (EMA)
  • European Medicines Agency (EMA) adopts positive opinion on Octapharma’s human cell line recombinant human FVIII (Nuwiq) in children and adults with haemophilia A (Press)
  • Annual meeting of the National Pharmacopoeia Authorities of the European Pharmacopoeia (NPA) (EDQM)
  • EDQM signs confidentiality agreement with TFDA (EDQM)
  • General Presentation on EUnetHTA (EUnetHTA)


  • CDSCO in the process of constituting 38 more new drug advisory committees (PharmaBiz)
  • How will Indian pharma sector shape up under new government? (India Times)
  • Maha FDA upgrades system to provide WHO GMP certificates in 10 days (PharmaBiz)

Japan & China

  • Analysis Suggests China No Longer Huge Cash Cow For Global Pharmas (PharmAsia-$) (Reuters)
  • Guangdong FDA To Create “Blacklist” Of Foods, Drugs And Cosmetics (PharmAsia-$)
  • GSK announces regulatory submission for umeclidinium monotherapy for COPD in Japan (Press)
  • Daiichi Sankyo Snags New Ranmark Indication in Japan (Press)
  • Merck Submits Gardasil Vaccine Clinical Trial Data To China FDA For Listing Approval (PharmAsia-$)


  • AllTrials in Push for Canadian Clinical Trials Transparency (AllTrials)
  • Authority to Sell Veterinary Drug Fees (HC)
  • Health Canada seeks input from patients on drug shortages (Vancouver Sun)

Other International

  • WHO's links to ICH under fire amid efforts to strengthen manufacturing regulations (Fierce)
  • WHO Publishes Draft Document on Strengthening Regulatory Systems for Medical Products (WHO)
  • First biogeneric for Iran (GaBi)
  • Australia: Literature based submissions (TGA)

General Regulatory And Interesting Articles

  • Suspended-animation trials to begin on humans (CNET)
  • The Unanswered Ethical Questions of Smartpill Technology (WaPo)
  • Two Looks At Drug Industry Productivity (InThePipeLine)
  • Military Plans To Test Brain Implants To Fight Mental Disorders (NPR)
  • Experimental Malaria Vaccine Blocks The Bad Guy's Exit (NPR)
  • Can the Nervous System Be Hacked? (NYTimes)
  • Antibiotic-resistant superbugs are as serious of a global threat as climate change, scientists say (MedCity News)
  • My No-Soap, No-Shampoo, Bacteria-Rich Hygiene Experiment (NYTimes)

Regulatory Reconnaissance #325 – 27 May 2014

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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