Regulatory Recon: Controversial Contraceptive Device Essure Under FDA Scrutiny (25 June 2015)

Posted 25 June 2015 By Alexander Gaffney, RAC

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

In Focus: US

  • FDA panel to discuss safety of Bayer's contraceptive device Essure (Reuters) (FDA) (WSJ-$)
  • Breakthrough Therapy Designation: Exploring the Qualifying Criteria (Brookings) (FDA)
  • Pharmacy Groups Seek Delay In DQSA Distributor Reqs Slated To Start July 1 (IHP-$)
  • US expands recommended use of meningitis B vaccines (PMLive) (Press) (Reuters)
  • House Appropriators Push FDA To Issue Generic Drug Labeling Rule That Mirrors Industry Alternative (IHP-$)
  • Sen. Kirsten Gillibrand berates FDA official for failing to expand medical marijuana to children with seizures (NYDN)
  • ​​Hackers are targeting biotech with eyes on insider trading (Reuters) (Fierce)
  • Combo Product Reforms Are A Priority For Next User Fee Round, FDA Officials Say (Gray Sheet-$)
  • Covidien agrees to settle some cases over transvaginal mesh devices (Reuters) (MassDevice)
  • Prescribing the right apps to the right patients (mHealthNews)

In Focus: International

  • Roche won't help to make Avastin available for AMD in France (SCRIP-$)
  • Fees under new Medical Device Regulation: Council of EU paints a different picture (Clinica-$)
  • Draft questions and answers on sodium in the context of the revision of the guideline on 'Excipients in the label and package leaflet of medicinal products for human use (EMA)
  • New Healthcare Leadership in the EU (Politico)
  • CTTI offers range of QbD recommendations for clinical trials (Outsourcing Pharma)

US: Pharmaceuticals and Biotechnology

  • Breakthrough Therapy Designation: Exploring the Qualifying Criteria (Brookings) (FDA)
  • Pharmacy Groups Seek Delay In DQSA Distributor Reqs Slated To Start July 1 (IHP-$)
  • US expands recommended use of meningitis B vaccines (PMLive) (Press) (Reuters)
  • House Appropriators Push FDA To Issue Generic Drug Labeling Rule That Mirrors Industry Alternative (IHP-$)
  • Sen. Kirsten Gillibrand berates FDA official for failing to expand medical marijuana to children with seizures (NYDN)
  • Patient Voices Shaping Medicine (BioCentury)
  • Lilly Facing First Trials Over Cymbalta Withdrawal Symptoms (Bloomberg)
  • Prometheus Takes Action Against FDA Over Generic LOTRONEX Approval and REMS Waiver, and Then Promptly Drops Case (FDA Law Blog)
  • FDA CMC Reviewer Recommendations for New Drug Approval Depend on Control Strategy Understanding, CDER is Stressing (IPQ-$)
  • FDA Drug Safety Communication: FDA reporting permanent skin color changes associated with use of Daytrana patch (methylphenidate transdermal system) for treating ADHD (FDA)
  • Hospira gets FDA OK for massive India plant from which Pfizer will reap the rewards (Fierce)

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

  • U.S. FDA Grants Priority Review for MM-398 New Drug Application (Press)
  • Novo's haemophilia drug prevents bleeds long term (PharmaTimes)
  • Alcobra dips on Fragile X data (BioCentury)
  • Transition falls after missing AD endpoint (BioCentury)
  • MERS getting more attention as vaccine candidate enters PhI (Fierce)

US: Pharmaceuticals and Biotechnology: General

  • ​​Hackers are targeting biotech with eyes on insider trading (Reuters) (Fierce)
  • What's worrying pharma? Reimbursement, yes, but also M&A, global threats, and the economy (Fierce)
  • The Impact of the Inter Partes Review on Biopharma (BIO)

US: Medical Devices

  • FDA panel to discuss safety of Bayer's contraceptive device Essure (Reuters) (FDA) (WSJ-$)
  • Combo Product Reforms Are A Priority For Next User Fee Round, FDA Officials Say (Gray Sheet-$)
  • Covidien agrees to settle some cases over transvaginal mesh devices (Reuters) (MassDevice)
  • Prescribing the right apps to the right patients (mHealthNews)
  • CBO Sets $158 Million Price Tag For Breakthrough Devices In Cures Bill (Gray Sheet-$)
  • The Esophageal Cooling Device gets FDA's rare de novo clearance for innovative devices (Fierce) (MassDevice)
  • GAO Weighs in on 3D Printing Challenges (GAO)
  • Pursuit of Cash Taints Promise of Gene Tests (NYTimes)
  • FDA Clears Sleep Apnea Device (Press)
  • The New England Journal of Medicine publishes LEVANT 2 results for the Lutonix Drug Coated Balloon, showing superior efficacy compared to standard PTA (Press)
  • Spectranetics Receives FDA 510(k) Clearance for Larger Diameter AngioSculpt Scoring Balloon Enabling Entry Into New Markets (Press)
  • FDA Approves Technology Upgrade for Recipients of First Commercially Available Cochlear Implant (Press)

US: Dietary Supplements

  • Supplement Firms Have 'Continuous Monitoring' Burden To Show Product Safety (Tan Sheet-$)

US: Assorted And Government

  • USDA considers additional reporting rules for animal testing (The Hill)
  • FDA's FOIA Team Processes 1 FOIA Request Every Ten Minutes on Average (FDAzilla)
  • Blumenthal, Senate Colleagues Ask for Study on Feasibility of Single Food Safety Agency (Bloomberg)

Upcoming Meetings and Events

Europe

  • Roche won't help to make Avastin available for AMD in France (SCRIP-$)
  • Fees under new Medical Device Regulation: Council of EU paints a different picture (Clinica-$)
  • Draft questions and answers on sodium in the context of the revision of the guideline on 'Excipients in the label and package leaflet of medicinal products for human use (EMA)
  • New Healthcare Leadership in the EU (Politico)
  • Guideline on core SmPC for plasma-derived fibrin sealant/haemostatic products (EMA)
  • London's mayor suggests quick $15B fix for financially ailing biotech sector (Fierce)
  • Newron Receives Positive Opinion for Orphan Medicinal Product Designation for Sarizotan to Treat Patients with Rett Syndrome from the Committee for Orphan Medicinal Products from the European Medicines Agency (Press)

Canada

  • Vancouver to regulate booming marijuana dispensaries (Reuters)

Clinical Trials

General Regulatory And Interesting Articles

  • Challenging the gold standard of double-blind drug trials (PharmJournal)
  • The Department of Defense Wants to Use Science to Make Soldiers Literally Fearless (Mic)
  • 'Virtual reality' treatment shows promise for alcoholism (Reuters)
  • For Vitiligo Patient, Arthritis Drug Restores Skin Color (Press)

Regulatory Reconnaissance #583 – 25 June 2015

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 @AlecGaffney or send him an email at news@raps.org.

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

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