Regulatory Recon: Apple Watch Doesn't Need to Be Regulated, CEO Says, Hints at Other Devices (10 November 2015)

Posted 10 November 2015 | By Michael Mezher 

Regulatory Recon: Apple Watch Doesn't Need to Be Regulated, CEO Says, Hints at Other Devices (10 November 2015)

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

  • More Intensive Blood Pressure Management Can Save Lives, SPRINT Study Finds (Forbes) (Reuters) (CardioBrief) (NIH)
  • Special Report: Popular heart surgery carried hidden danger (STAT)
  • Tim Cook: Watch doesn’t need FDA regulation, but Apple making other medical products (BGR) (The Telegraph)
  • Silicone breast implants still lack proof of safety (Reuters)
  • Common Antibiotics Cause Arrhythmias, Death And Everything Else (Forbes) (Study)
  • The Crispr Quandary (NYTimes) (The New Yorker)
  • Use of Long-Acting Birth Control Methods Surges Among U.S. Women (NYTimes) (NPR)
  • PDUFA VI Might Adjust Establishment Fees; FDA Aims For Simplification (Pink Sheet-$)
  • Harvard Pilgrim strikes ‘pay-for-performance’ deal for cholesterol drug (Boston Globe)

In Focus: International

  • Prime Minister intervenes on future of Cancer Drugs Fund (PharmaPhorum)
  • Government blames India's poor quality stigma on 'turf war' with West (In-PharmaTechnologist)
  • US to ask Canada, UK to extradite online pharmacy officials (AP)
  • US court imposes temporary sales ban on Dr Reddy's generic Nexium (Reuters)
  • Dr Reddy's says new drug approvals will be delayed (Economic Times)
  • Taiwan FDA Raises Questions About Biosimilar Approvals (DrugWonks)
  • Global Health and the WHO: Revival or Marginalization? (CFR)
  • The Oral Polio Vaccine Can Go 'Feral,' But WHO Vows to Tame It (NPR)

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US: Pharmaceuticals and Biotechnology

  • Biosimilars may be sold at discount of 15 to 30% despite delay in launches globally (PharmaBiz)
  • Of the person, by the person, for the person: The road to precision medicine (Faster Cures)
  • There’s an App for That Too! FDA Gives a Post-Halloween Treat and Releases the Orange Book Express App (FDA Law Blog)
  • Reimagining How The Safety Net Provides Treatment For People Living With HIV (HealthAffairsBlog)
  • Good Talks Needed to Combat HPV Vaccine Myth (NYTimes)
  • OMQ Official: Majority of Drug GMP Warning Letters Mention Data Integrity (FDANews-$)

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

  • AstraZeneca lupus drug impresses in mid-stage trial (Reuters)
  • Teva's late-stage Huntington's drug scores 'breakthrough' bragging rights at FDA (FierceBiotech) (Press)
  • Lilly diabetes drug cuts heart failure death, hospitalization: study (Reuters) (Press)
  • Real-World Analysis of more than 44,000 Patients Reinforces Safety and Effectiveness of Pradaxa in Routine Clinical Care (Press)
  • Boehringer Ingelheim Presents New idarucizumab (Praxbind) Analyses on Reintroduction of Antithrombotic Therapy after Reversal of Dabigatran (Press)
  • Dyax Corp. Presents Phase 1b DX-2930 Data at the American College of Allergy, Asthma, and Immunology Annual Meeting (Press)

US: Medical Devices

  • Insulin pumps give kids better control of type 1 diabetes (Reuters)
  • Study shows advantages of mitral valve replacement over repair (Reuters)
  • More DTC Gene Test Firms Hit With FDA Untitled Letters (Gray Sheet-$) (Focus)
  • Pfizer: Think patient-first when developing mobile health apps (MobiHealthNews)
  • Medtronic’s Micra pacer trial meets endpoints (MassDevice) (Reuters) (Medtronic)
  • St. Jude touts study showing CardioMEMS reduces heart failure hospitalizations by 48% (FierceMedicalDevices) (Press)
  • FDA clears Edap’s Ablatherm prostate device (MassDevice)
  • Xeltis Completed Second Feasibility Clinical Trial on Bioabsorbable Cardiovascular Device Technology (Press)
  • Si-Bone wins FDA 510(k) for iFuse sacroiliac joint system (MassDevice)
  • Concussions in kids are detectable by blood test (MNT)
  • Steps forward in the hunt for easily measurable biomarkers of autism (MNT)
  • Interventional Spine Gains FDA Clearance of Advanced Design of Its Expandable Opticage® for Spinal Fusion (Press)
  • FDA Accepts PMA Submission for ReVision Optics’ Raindrop Near Vision Inlay (Press)
  • FDA Approves InnFocus Glaucoma Study Expansion (Press)

US: Assorted and Government

  • Did Fed. Circ. Doom The New Biosimilar Approval Pathway? (Law360-$)
  • US top court allows Apotex to pursue generic version of Daiichi drug (Reuters)
  • 'Benghazi'-Like Hearing Unlikely For Califf, But Expect Questions (SCRIP-$)
  • High Court Asked To Review Standing In Prosthetic IP Row (Law360-$)
  • FDA Calls for Comments on the Use of the Term 'Natural' in Food Labeling (Federal Register)
  • GOP Hopefuls, Long Quiet on Drug Prices, Begin to Make Some Noise (STAT)
  • Punitive Damages – How Much Increased Risk Is Enough? (Drug and Device Law)
  • Class Action Lawsuit Against Valeant Pharmaceuticals (PharmPro)
  • Citron turns spotlight on Mallinckrodt, shares plunge (Reuters) (Bloomberg) (SCRIP-$)
  • California: Plan Proposed for Single-Drug Executions (NYTimes)

Upcoming Meetings and Events              


  • RoHS, REACH and the Rest: EU Substances Regulation Applicable to Medical Devices and IVDs (MDDI)
  • Germany approves migraine drug Rizaport (BioCentury)
  • European Commission Unveils New Scientific Advisor Group (EC)
  • NHS faces 'financial disaster' (OnMedica)
  • EU, US Clinical Data Conundrum: Careful Assessment Needed With Current State Of Flux (Clinica-$)
  • German Insurer Says Baxter Docs Not Privileged Under Ill. Law (Law360-$)
  • Window Into HTA: Where Is the EU At With Its HTA Network? (Clinica-$)


  • AIMED launches UdaiMed, India’s first industry-academia collaboration for medical devices R&D (PharmaBiz)
  • Union govt and CDC implement Labs for Life Partnership project to strengthen quality of tests & infrastructure (PharmaBiz)
  • FDA approves Glenmark’s generic Lotrisone (DSN)
  • Dr Reddy's Set For Quality Revamp Amid FDA Warning (SCRIP-$)


  • Luye's schizophrenia drug gets nod to move ahead with NDA approval (FiercePharmaAsia)
  • China poses a continued challenge for Novo Nordisk, Tresiba CFDA nod seen key (FiercePharmaAsia)


  • Astellas to Acquire Ocata Therapeutics (Astellas)
  • Thrasos Strengthens Composition of Matter Coverage on THR-184 with Japanese Patent Decision (Press)


  • AusPAR: Sevelamer hydrochloride – Rejected (TGA)
  • Australian government earmarks A$630 million for over 800 innovative research projects (PharmaLetter-$)

Other International

  • IPC set to become first WHO Collaborating Centre for Safety of Medicines and Vaccines in APAC (BioSpectrum)
  • How Vietnam Mastered Infectious Disease Control (PBS)

General Health and Other Interesting Articles

  • Scientists Make Strides in Inhibiting Infection in Artificial Ebola Virus Model (ICT)

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.

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