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Regulatory Recon: Report Finds FDA's Acceptance of Retrospective Adverse Event Summaries Obscures Device Safety Data (17 October 2016)

Posted 17 October 2016 | By

Regulatory Recon: Report Finds FDA's Acceptance of Retrospective Adverse Event Summaries Obscures Device Safety Data (17 October 2016)

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

In Focus: US

  • Celgene Crohn's Drug Benefit Supported by Image Data in Trial (Bloomberg) (Pharmafile) (The Street)
  • FDA rules allow medical device makers to keep injuries under wraps (Star Tribune)
  • FDA places Regeneron and Teva's pain-drug study on hold (Reuters) (Press)
  • Biden's final 'cancer moonshot' report outlines progress and hurdles (Washington Post)
  • Clinton campaign staff: "We have started the war with pharma!!" (Endpoints) (Fierce) (Wikileaks)
  • US Clears Way For Cuban Drugs (Focus)
  • FDA Denies PTC's Appeal Over February Refuse to File Letter (Press)
  • Valeant Pharmaceutical release their latest price increases (Pharmafile) (The Street) (PharmaLetter-$) (WSJ) (Forbes)
  • She's calling for a health care revolution. The radical first step: listen to patients (STAT)
  • Scientists seek to map all human cells in vast atlas (Reuters)
  • As cyberthreats multiply, hackers now target medical devices (CNBC)
  • Sperm test 2.0: New diagnostics aim to better understand male infertility (STAT)
  • Can CRISPR Save Ben Dupree? (MIT Technology Review)
  • Specialist Fund Flows Help Fuel The Biotech Capital Markets (LifeSciVC)
  • Meet Prelude Fertility, The $200 Million Startup That Wants To Stop The Biological Clock (Forbes)
  • Coating issue still plagues the Pipeline device as Medtronic issues another recall (MassDevice) (WSJ) (Press)
  • U.S. Seeks Curb on Chemicals Used to Make Fentanyl, a Powerful Opioid (WSJ)
  • The Nutrition Mission at the FDA (WSJ)

In Focus: International

  • Explosion at BASF (In the Pipeline)
  • EMA Appeals Interim EU Court Orders Preventing Access To Documents (Pink Sheet-$)
  • EU-US agreement offers new opportunities for research cooperation (EC) (Agreemement)
  • European Commission Strongly Recommends the Use of Generic and Biosimilar Medicines to Ensure the Sustainability of Healthcare Systems (Medicines for Europe) (Report)
  • FDA, EMA Officials: Regulators Must Adapt To Effectively Regulate Precision Medicine (Focus)
  • Venclyxto Gets EU Nod – But Won't Be A Humira Replacement For AbbVie Yet (SCRIP-$)
  • FIRM looks to fix blips in Japan's fast-track regenerative medicine system (BioPharmaReporter)
  • Hanmi Pharmaceutical raided over insider trading suspicions (Pharmafile)
  • UNCTAD competition policy meeting to discuss 'Big Pharma' tactics (PharmaLetter-$)
  • Cipla signs deal to set up first biosimilars unit in South Africa (Economic Times)
  • Failings Of Clinical Trials, Adaptive Pathways Dominate NGO Conference (Pink Sheet-$)
  • Lilly Plans Raft Of India Launches After Trulicity Success (SCRIP-$)
  • NHS told not to expect extra funding (PharmaTimes)
  • Draft Chinese FDA Medical Device Classification Catalogue would Reduce Number of Device Groups (Emergo)
  • Brexit Means Brexit--What does that mean for Europe's medical device industry? (Emergo)
  • "Real-world" evidence for vedolizumab's clinical effectiveness and safety (PharmaLetter-$)

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US: Pharmaceuticals & Biotechnology

  • West Virginia Grapples With High Drug Costs (NPR)
  • BPCIA Litigation Summary Chart (Big Molecule Watch)
  • Ex-Celgene Dealmaker Tom Daniel Charts a New Course Advising Biotechs (Xconomy)
  • FDA Proposes Withdrawing Approval for Aprotinin, Bromocriptine mesylate and Ondansetron hydrochloride (FDA)
  • Cleveland Clinic: Pharma can't police its own prices (Fierce)
  • FDA Proposes to Withdraw ANDA for Mallinckrodt, Kremers HCI Extended Release Tablets (FDA 1, 2)
  • High quality comparative effectiveness research (Healthcare Economist)
  • Bristol waits for the other PD-1 shoe to drop (EP Vantage)
  • Falling behind, TG tears up clinical plan and talks up combo (EP Vantage)
  • Pfizer retractions point to the need for better research oversight (MedCityNews)
  • Ariad shares dive after Sanders' attack (BioCentury)
  • Adverum delays start of gene therapy PhI/II by one year, blames manufacturing (Fierce)
  • Medical Errors – The Third Leading Cause of Death in the US (Harvard Bill of Health)
  • Organs and Overdoses: The Numbers (Part I) (Harvard Bill of Health)
  • MS Treatment Strategies: A Review of Disease-Modifying Therapies (MPR)

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

  • OncoGenex's Phase 3 non-small cell lung cancer trial did not meet primary endpoint(EPR)
  • Flex Pharma slips again after FLX-787 update (BioCentury)
  • Leonhard Lang Multi-function Defibrillation Electrodes DF29N Will Not Work with Welch Allyn Automatic External Defibrillator model AED 10 (FDA 1, 2)
  • FDA approves Protein Sciences quadrivalent flu vaccine (BioPharmaReporter)
  • FDA Approves Genentech's Lucentis® (Ranibizumab Injection) Prefilled Syringe (Press)
  • Oral GED-0301 Phase 1b Results Show Clinical Remission and Endoscopic Response at Week 12 in Patients with Active Crohn's Disease (Press)
  • PanOptica Reports Positive Results from Phase 1/2 Clinical Trial of PAN-90806, a Novel Topical Anti-VEGF Eye Drop (Press)
  • Oral Ozanimod Efficacy and Safety Results from Phase 2 TOUCHSTONE Extension Trial in Patients with Ulcerative Colitis to Be Presented at UEGW and ACG (Press)
  • Omeros Announces Positive Data from OMS721 Phase 2 Clinical Trial in Renal Diseases (Press)
  • New Colombia Resources Forming Joint Venture to Apply for an Orphan Drug Designation with the Food and Drug Administration (FDA) for a Medical Cannabis Pharmaceutical Product (Press)

US: Medical Devices

  • Philips wins FDA nod for Lumify S4-1 transducer (MassDevice) (Press)
  • FDA Classifies Upper Extremity Prosthesis Including a Simultaneously Powered Elbow and/or Shoulder with Greater Than Two Simultaneous Powered Degrees of Freedom and Controlled by Non-Implanted Electrical Components into class II (FDA)
  • FDA approves Genentech's Lucentis pre-filled ranibizumab syringe (MassDevice)
  • Five ways to avoid scope creep in clinical trial execution (MassDevice)
  • Teleflex Receives FDA Clearance for the Arrow® Midline with Chlorag+ard® Technology (Press)
  • Medical Devices; Cardiovascular Devices; Classification of the Apical Closure Device (FDA)

US: Assorted & Government

  • CMS Launches Final MACRA Rule (Medpage) (Policy and Medicine) (Forbes 1, 2)
  • Trump is 'doubling down' on the opioid crisis with promises of expanded treatment (STAT)
  • Virtus Pharmaceuticals, LLC Files Lawsuit Against the Food and Drug Administration and Department of Health and Human Services (Press)
  • What Is An Acceptable Drug Discount? DOJ and Industry Disagree (Pink Sheet-$)
  • 600,000 New Reasons The Affordable Care Act is Sinking (Forbes)
  • Bootstrapped Claim Against the FDA Gets the Boot (Drug and Device Law)
  • Pfizer Settles Long-Running Cancer Research IP Suit (Law360-$)
  • Pfizer Unit To Pay Feds Extra $230K For NJ Pollution (Law360-$)
  • The Problem With an All-or-Nothing Approach to GMO Foods (WSJ)
  • Ut Oh ... Not So Fast ... DEA Withdraws Notice of Intent to Place Opioids Mitragynine and 7-Hydroxymitragynine – the Main Active Constituents of the Plant Kratom – in CSA's Schedule I (FDA Law Blog)

Upcoming Meetings & Events


  • Occlutech recalls cardiac implant on dislodgement risk (MassDevice)
  • Celon Pharma Gains 19% in First Day of Warsaw Trading (Bloomberg)
  • UK launch for Bial's Parkinson's drug (PharmaTimes)
  • Ukraine pharma seeks clarification on undue pressure and interference by law enforcement authorities (PharmaLetter-$)
  • Cost of Spain's pharma industry to adapt production lines to medicines verification system (PharmaLetter-$)
  • Dutch regulator calls for shelf life after opening to be listed on OTC packaging (PharmaLetter-$)
  • AbbVie and Roche's leukaemia drug venetoclax nears EU market (PMLive)
  • Medtronic, LivaNova get in on $12m round for European medtech incubator MD Start (MassDevice)
  • Apitope reclaims multiple sclerosis treatment from Merck after 7 years (Pharmafile)
  • CERN researcher's fertility app is as good as oral contraceptives, condoms(MassDevice)
  • Medrobotics® Corporation Receives Expanded CE Mark for Flex® Robotic System (Press)
  • Marketing authorisations granted in September 2016 (MHRA)
  • Parallel import licenses granted in September 2016 (MHRA)


  • China touts reforms, vows to battle corruption in organ donation system (Reuters)


  • Govt sets Nov 15 deadline for state drug regulators to follow new norms on uniform GMP inspections (PharmaBiz)
  • WHO issues guidance on GRP for medical products, stakeholders, comments sought by year-end (PharmaBiz)
  • Your insulin, hepatitis B vaccine may get cheaper (Times of India)
  • Pharma companies may report subdued performance in Q2 FY17: Report(Economic Times)
  • Dr. Reddy's to Release Q2 FY17 Results on Oct 25, 2016; Earnings Call Slated for Oct 25, 6.30 PM IST / 9.00 AM EDT (Press)
  • Glenmark rises armed with research after five year hiatus (Economic Times)


  • Premature battery depletion with certain St. Jude Medical implantable defibrillators (Health Canada)


  • Certified product details (CPD) - Biological prescription medicines (TGA)


  • One Family's Struggle with Microcephaly (NYTimes)

General Health & Other Interesting Articles

  • Data Mining Is Revolutionizing Our Understanding of Human Weight Change (MIT Technology Review)
  • US diabetics have worsening blood sugar control (Reuters)
  • Sleep apnea may up risk of type 2 diabetes (Reuters)

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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