Regulatory Focus™ > News Articles > Regulatory Recon: New EU Device Legislation Taking Shape (23 June 2014)

Regulatory Recon: New EU Device Legislation Taking Shape (23 June 2014)

Posted 23 June 2014 | By Alexander Gaffney, RAC

Regulatory Recon: New EU Device Legislation Taking Shape (23 June 2014)

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

In Focus: US

In Focus: International

US: Pharmaceuticals and Biotechnology

  • FDA Approves Cubist's Skin Infection Drug Sivextro (FDA) (Press) (PharmaPhorum) (Pharma Times) (Xconomy) (Forbes) (Modern Healthcare) (SCRIP-$) (BioCentury) (Bloomberg)
  • Bill Seeks to Facilitate the Research, Development, and Approval of Drugs With an Eye Towards Male and Female Differences (FDA Law Blog) (Bill)
  • FDA staff question validity of benefit seen with AstraZeneca drug (Reuters)
  • Public Citizen To Congress: Scrap Bid To Nix FDA Generic Labeling Rule (IHP-$)
  • CDER’s Automated NDA Assessment Tool May Expand Beyond Clinical Reviews (Pink Sheet-$)
  • FDA Warns Oncology Drug Docetaxel Can Cause Drunken Side Effects (Medpage Today) (FDA) (FDA) (Law 360-$)
  • FDA Drug Shortage Page Gets a Facelift (FDA)
  • FDA Denies Citizen Petition by Public Citizen Requesting Black Box Warnings on Statin Drugs (FDA)
  • FTC Increasing Scruting of Pay-for-Delay Deals (Bloomberg)
  • Marijuana Considered for Looser Restrictions by U.S. FDA (Bloomberg) (FDA) (The Hill)
  • DEA Proposing Adjustments to Production Quotas of Schedule I/II Drugs (DEA)
  • FDA actions reduce drug shortages but critical issues remain (FDA)
  • CV Trials For Symptomatic Conditions Feasible But Not Always Practical, FDA Panel Says (Pink Sheet-$)
  • Cardiovascular Outcomes Data Transparency Vexes FDA, Sponsors (Pink Sheet-$)
  • New FDA Database May Have Negative Consequences (Law 360-$)
  • Industry Cost Estimates For Proposed Consumer Antiseptic Rule Dwarf FDA’s (Tan Sheet-$)
  • ASCO Method For Valuing Cancer Drugs To Reflect Biopharma, Patient Input (Pink Sheet-$)
  • Drug Firms Express Concern With ASCO Value Initiative (Pink Sheet-$)
  • Veterinarians Form Compounding Task Force As FDA Plans Policy Update (IHP-$)

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

  • Early Results Arrive on Weight-Loss Pills That Expand in the Stomach (NYT)
  • Orexo: Positive Top-Line Results from Two Phase 3 Clinical Trials That Assessed Zubsolv for Induction of Buprenorphine Maintenance Therapy (Press)
  • Positive new Ph IIIa data on Novo Nordisk’s liraglutide (Pharma Letter-$)
  • The EMA and FDA Grant Orphan Drug Designation to Pharnext's PXT-3003 for the Treatment of Charcot-Marie-Tooth Disease Type 1A (Press)

US: Pharmaceuticals and Biotechnology: General

  • Health Insurers Pressing Down on Drug Prices (NYT)
  • Americans Weigh Addiction Risk When Taking Painkillers (NPR)
  • Shortage Of Saline Solution Has Hospitals On Edge (NPR)
  • SCRIP's US Capitol Capsule (SCRIP-$)

US: Medical Devices

  • Medtronic got hacked, company reveals (Mass Device)
  • FDA to review 510(k) for 23andMe health report (BioCentury)
  • Drug Software Co. Can't Duck Warning Suit On Appeal (Law 360-$)
  • Proper Clinical Trial Design of Interventional Cardiology Devices May Influence Reimbursement (MDDI)
  • FDA clears Qardio’s sleek, connected blood pressure device (MobiHealthNews)
  • Recall for ConvaTec Device not Cleared by FDA (FDA)
  • Mammography Problems at Big Sky Diagnostic Imaging, LLC in Butte, Montana: FDA Safety Communication (FDA)

US: Dietary Supplements

  • Ample Authority, Thin Resources For Supplement Claims Enforcement – CRN, NPA (Tan Sheet-$)
  • Five surprising herbs that can damage your liver (Today)

US: Assorted And Government

  • SCOTUS to Decide Whether Rulemaking Is Required When Agencies Change Established Guidance on Statutes and Regulations (Federal Register Advisor)
  • Happy Birthday to the Pure Food and Drugs Act (Politico)

Europe

  • EU looks toward new medical device legislation in 2015 (Fierce) (MedicalDevicesLegal) (Clinica-$)
  • Italian officials probe Novartis for possible flu vaccine pricing fraud (Pharmafile) (Fierce) (Pharmalot)
  • NICE to expand use of bloodthinner Efient (Pharma Times)
  • Pharma gets social: did digital opinion leaders shape NICE guidance on Xtandi? (PharmaPhorum)
  • Registration opens for workshop on dose finding at the European Medicines Agency (EMA) (EMA)
  • Current HTA system not fit for purpose, ABPI tells NICE (Pharma Times)
  • PhRMA and EFPIA commissioned report on HTAs finds concerns over speed and transparency (PharmaLetter-$)
  • GlaxoSmithKline sorry for drugs trial pitch to unpaid interns (Guardian) (Pharmalot)
  • Triphase Accelerator Corporation Announces Orphan Drug Designation in the European Union for Marizomib for Multiple Myeloma (Press)

India

  • India To Study Drug-Pricing Models In Other Countries For New Plan (PharmAsia-$)
  • 'Draft Guidelines for Examination of Patent Applications' show bias against pharma sector: PhRMA (PharmaBiz)

Japan & China

  • Supplement Regulations overhaul proceeding rapidly in Japan, ASEAN (NI-USA)

Other International

  • Australian Regulators Investigators Cardiovascular Events in Coralan (Ivabradine)
  • CV Trials For Symptomatic Conditions Feasible But Not Always Practical, FDA Panel Says (Pink Sheet-$)
  • Cardiovascular Outcomes Data Transparency Vexes FDA, Sponsors (Pink Sheet-$)
  • Bill Seeks to Facilitate the Research, Development, and Approval of Drugs With an Eye Towards Male and Female Differences (FDA Law Blog) (Bill)
  • Proper Clinical Trial Design of Interventional Cardiology Devices May Influence Reimbursement (MDDI)

Clinical Trials

  • The risks and benefits of clinical trials in emerging markets (PharmaPhorum)
  • CV Trials For Symptomatic Conditions Feasible But Not Always Practical, FDA Panel Says (Pink Sheet-$)
  • Cardiovascular Outcomes Data Transparency Vexes FDA, Sponsors (Pink Sheet-$)
  • Bill Seeks to Facilitate the Research, Development, and Approval of Drugs With an Eye Towards Male and Female Differences (FDA Law Blog) (Bill)
  • Proper Clinical Trial Design of Interventional Cardiology Devices May Influence Reimbursement (MDDI)

Regulatory Reconnaissance #342 – 23 June 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.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

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.


Categories: Recon, Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe