Regulatory Recon: FDA Backs Out of Recall for Scope-Cleaning Machine MHRA Issues 'Borderline' Device Guidance (6 May 2016)

Posted 06 May 2016 | By Michael Mezher 

Regulatory Recon: FDA Backs Out of Recall for Scope-Cleaning Machine MHRA Issues 'Borderline' Device Guidance (6 May 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

  • Pfizer Needs Clearer Goals (NYTimes)
  • FDA Retreats From Recall Of Scope-Cleaning Machines Tied to Outbreaks (KHN)
  • 3 patients died in a Pasadena outbreak possibly caused by medical scopes (LA Times)
  • Gene Therapy's First Out-and-Out Cure Is Here (MIT Technology Review)
  • Second baby gets Cellectis 'designer' cells to clear leukemia (Reuters)
  • Lawmakers Criticize Medicare Plan for Costly Drugs (WSJ)
  • In Prince's Battle With Pain Medication, a Common Refrain (NYTimes)
  • Social Media And Medical Journals: The Streetlight Effect (CardioBrief)
  • ISO 13485:2016 – Putting off compliance until the last minute could cost you dearly (Emergo)
  • It's Time For FDA To Follow Through On Prescription Opiates. Do It For Prince. (Forbes)
  • Endo Cuts Annual Guidance on Impairment Charge (WSJ)
  • Wall Street betting intensifies over Sarepta's muscular dystrophy drug (STAT)

In Focus: International

  • UK's early access to medicines scheme 'not fit for purpose' (PharmaLetter-$)            
  • Spain gets first case of Zika-related brain defect in a fetus (Reuters)
  • MHRA Issues Guidance on 'Borderline' Medical Devices (MHRA)
  • India Ministry of Health Calls on Drug and Device Associations for Feedback (CDSCO)
  • Health Canada Requires Updated Warning on Gleevec Labeling for Brand and Generics (24 Insight)
  • Valeant forms internal committee to oversee drug pricing (Reuters) (WSJ)
  • Sanofi, Amgen cholesterol drugs win UK backing after price cuts (Reuters) (BioCentury) (MNT)
  • Canadian Medtech Keeps An Eye On Transition To MDSAP; Regulator Won't Allow Grace Period (SCRIP-$)

US: Pharmaceuticals & Biotechnology

  • Regeneron: PCSK9s Drowning In Paperwork (Pink Sheet-$)
  • Regeneron raises Eylea guidance (BioCentury)
  • Merck to expand Cali viral and gene therapy plant (BioPharmaReporter)
  • The Benefits Of Using An Independent CRO To Manage Your DSMB Or CEC(iMarc)
  • Are Drug Prices Really Too High? (National Law Review)
  • FDA reminds health care professionals not to use drug products intended to be sterile from Medaus (FDA)
  • Morning Read: GSK nears approval of curative gene therapy for "bubble boy" disease (MedCityNews)
  • Amgen looking to join the fray, mulling Medivation bid – Reports (Pharmafile)
  • Acadia Drug Approval May Entice Biogen, Teva as Buyers (The Street)
  • FDA to Renew Pharmacy Compounding Advisory Committee (FDA)
  • Biomagnetic Separation: Thinking Bigger, Part II (Pharmaceutical Manufacturing)
  • CRISPR Drug Maker Intellia Therapeutics Sells $108M In IPO Shares (Xconomy)
  • Cutting pills in half may save you a bunch in prescription drug costs (Washington Post)
  • Baxter boosts Baxalta share exchange offer (MassDevice)
  • Modernising strategies for monitoring clinical trials (PharmaPhorum)
  • Development of a Novel Zika Vaccine with MVA-VLP Technology (BIO)
  • Clovis Pulls Plug On Rociletinib On Expected FDA Rejection (SCRIP-$) (BioCentury)
  • Clovis cuts staff by 35% after FDA knock back on lung cancer drug (Pharmafile)
  • Parkinson's Drug Nuplazid Priced High; Acadia Aims For Alzheimer's Next (SCRIP-$)
  • Event – Ultragenyx looks to data from its biggest projects (EP Vantage)
  • New Class of Drug Ferrying Nanoparticles May Overcome Limitations of Existing Systems (medGadget)
  • Merck Is Finding PD-L1 Testing Is Helping Keytruda (Pink Sheet-$)

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

  • Bayer's Stivarga improves liver cancer survival rates, trial shows  (PharmaLetter-$)
  • Rock Creek granted Japanese, European, US Patent for lead compound (BioSpectrum)
  • Positive top line results announced for inhaled anti-RSV nanobody (alx-0171) in a phase I/IIa study in infants (MNT)
  • Novaliq Announces Last Patient Enrolled in Phase 2 Clinical Trial of CyclASol for the Treatment of Moderate to Severe Dry Eye Disease (Press)
  • Crospon Receives Expanded Indications from FDA for EndoFLIP Catheter (Press)
  • TOLMAR Pharmaceuticals Announces That FDA Approval Has Been Received For ELIGARD (leuprolide acetate for injectable suspension) Storage At Room Temperature For Up To 8 Weeks (Press)

US: Medical Devices

  • Valeant collaborates with IBM on cataract app (PharmaPhorum)
  • Artificial vision device may help nearly-blind people (Reuters)
  • Fitbit CEO hints at expanding healthcare strategy, FDA-cleared devices (Mobihealthnews)
  • The Pathetic State of Remote Cardiac Monitoring Today (MDDI)
  • How Design Controls Apply to a 510(k) (Greenlight Guru)
  • New study shows patients with pacemakers and sleep apnea are at increased risk of atrial fibrillation (MNT)
  • Signostics Receives FDA Clearance for Uscan – The World's First Smart Mobile-Connected Visualization Device Specialized for Urologic Care (Press)

US: Assorted & Government

  • FDA Sets Enforcement Date for Restaurant Menu (and Coupon!) Labeling (FDA Law Blog)
  • NIH recognizes 20 recipients of the Presidential Early Career Award for Scientists and Engineers (NIH)
  • FDA Finalizes Compliance Policy Guide: Pet Food Diets Intended for Sick Animals are Drugs but FDA will Exercise Enforcement Discretion under Limited Circumstances (FDA Law Blog)
  • Court Says Auf Wiedersehen To Plaintiffs Under Forum Non Conveniens (Drug and Device Law)
  • House Democrats Push For $600M To Fight Opioid Abuse (Law360-$)
  • Three more companies face shareholder wrath over executive pay (The Guardian)

Upcoming Meetings & Events



  • Toshiba promotes medical chief Tsunakawa to CEO (MassDevice)
  • Daiichi Sankyo reveals outcome of arbitration proceeding with former Ranbaxy shareholders (BioSpectrum)


  • Blood Glucose Test Strips in India Must Comply with ISO-15197 (CDSCO)
  • IPC to draft good pharmacovigilance practices guidance document for industry soon (PharmaBiz)
  • Aurobindo Pharma gets final USFDA nod for cholesterol drug (Economic Times)
  • India Orders Panel To Restrict Import Of Refurbished Radiology Devices (Gray Sheet-$)


  • Australian IP Inquiry Unimpressed By Calls For More Data Exclusivity (SCRIP-$)



  • On The Zika Front Lines: Genetically Modified Mosquitoes To Be Unleashed In Caymans (KHN)

Other International

  • Ebola May Lead to Blindness in Survivors According to New Findings (ICT)
  • Medical aid group pulls out of 'fig-leaf' U.N. humanitarian summit (Reuters)

General Health & Other Interesting Articles

  • Bloomberg's New Gender-Equality Index (The Atlantic)
  • When Hospital Rooms Become Prisons (NYTimes)
  • NINR Releases New Materials For Navigating Pediatric Palliative Care (Forbes)

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.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

Categories: Recon, Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles