Regulatory Focus™ > News Articles > Regulatory Recon: FDA's Authority to Regulate Device Leasing Challenged (3 April 2015)

Regulatory Recon: FDA's Authority to Regulate Device Leasing Challenged (3 April 2015)

Posted 03 April 2015 | By Alexander Gaffney, RAC

Regulatory Recon: FDA's Authority to Regulate Device Leasing Challenged (3 April 2015)

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

In Focus: US

  • FDA Mission Creep: Don’t Lease Your 510(k) (MDDI)
  • Industry Weighs in on De Novo Classification Draft Guidance (MDDI)
  • Medtronic to pay feds $4m to settle product labeling case (Mass Device) (DOJ)
  • Takeda Offers $2.2 Billion to Settle Actos Drug Cases (Bloomberg)
  • FDA Issues Warning About North Carolina Compounding Pharmacy (FDA) (Law 360-$)
  • FDA Extends Comment Period on Identifying Potential Biomarkers and Qualification (FDA)
  • Generic Cases Still Face Tough Odds After High Court Snub (Law 360-$)

In Focus: International

  • A New Cancer Drug, Made Entirely in China (WSJ-$)
  • Canadian Guidance Clarifies Reconsideration Timelines (FDAnews-$) (Health Canada)
  • Trends in European Generics and Biosimilars (FDA Life) (2)
  • Taking a Closer Look at ICH Q2 (R1) (PharmaManufacturing)
  • A Deep Look into the Supply Chain Issues of Africa (IRIN)

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US: Pharmaceuticals and Biotechnology

  • Takeda Offers $2.2 Billion to Settle Actos Drug Cases (Bloomberg)
  • FDA Issues Warning About North Carolina Compounding Pharmacy (FDA) (Law 360-$)
  • FDA Extends Comment Period on Identifying Potential Biomarkers and Qualification (FDA)
  • Generic Cases Still Face Tough Odds After High Court Snub (Law 360-$)
  • Ask Your Doctor? Direct-to-Consumer Advertising of Pharmaceuticals (NBER-$)
  • Roche's New Accutane Warning Label OK, Judge Rules (Law 360-$)
  • Vivus Seeks FDA Approval for Cost-Saving Clinical Trial Changes (Pharmalot)
  • New FDA Q&A Guidance on Residual Solvents in Animal Drug Products (FDA) (FDA)
  • Actavis seeking FDA Approval to market generic version of Gilead drug (MarketWatch) (Press)
  • Return Of Vertex’s Ivacaftor To FDA Panel May Signal Efficacy Concerns (Pink Sheet-$)
  • Dystrophin Disconnect? FDA Workshop Indicates Slow Pace Of Biomarker Development (RPM Report-$)
  • Sandoz responds to Amgen in Zarxio case (BioCentury)
  • Right to Try Bill Advances in Tennessee (Press)
  • Alabama Right to Try Bill to be Introduced Shortly (Alabama.com)
  • Florida Right to Try Bill Hits Opposition (Herald Tribune) (Scout)
  • Utah Governor Herbert Signs Bill Ensuring Patient Access to Interchangeable Biologic Medicines (Press)
  • Biosimilar Substitution Bill Filed in Louisiana (Scout)
  • CBER Gets a New Address (FDA)

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

  • FDA grants review of Repros hypogonadism drug; shares rocket (SCRIP-$)

US: Pharmaceuticals and Biotechnology: General

  • Hayman’s Bass Targets Shire in New Drug Patent Challenges (Bloomberg) (Pharmalot)
  • Teva Strikes $24M Deal To Exit Nexium Pay-For-Delay Suit (Law 360-$)
  • Myths that undermine medical research (The Hill)
  • The State of Vaccine Confidence in the US (HHS) (Report)

US: Medical Devices

  • Industry Weighs in on De Novo Classification Draft Guidance (MDDI)
  • FDA Mission Creep: Don’t Lease Your 510(k) (MDDI)
  • Medtronic to pay feds $4m to settle product labeling case (Mass Device) (DOJ)
  • Draft Guidance Makes Early Preparation For FDA Device Panel Meetings More Important Than Ever (Gray Sheet-$)
  • More Health Insurers Take Action to Curb Morcellator Use (WSJ-$)
  • Philips stumbles again in CT manufacturing as FDA reveals a recall (Fierce)
  • Bruker Announces FDA Clearance for Second, Expanded Claim for the MALDI Biotyper CA System (Press)
  • Augmenix Announces FDA Clearance of SpaceOAR System (Press)

US: Dietary Supplements

  • Diet Pill Maker, Snooki Can't Dodge False Ad Class Action (Law 360-$)
  • How should the FDA regulate homeopathic remedies? (SBM)

US: Assorted And Government

  • Critical Path Innovation Meetings: A New Opportunity to Discuss Drug Development Issues with FDA (FDA Law Blog)

Upcoming Meetings and Events

Europe

  • Trends in European Generics and Biosimilars (FDA Life) (2)

India

  • India to add more AIDS, TB drugs to essential medicines list (Reuters)

China

  • A New Cancer Drug, Made Entirely in China (WSJ-$)
  • Chinese authorities receive over 560,000 complaints on food, drugs in 2014 (Want China Times)

Canada

  • Canadian Guidance Clarifies Reconsideration Timelines (FDAnews-$) (Health Canada)
  • Respond to Canadian consultation on clinical trial transparency regulations (AllTrials)

Other International

  • Taking a Closer Look at ICH Q2 (R1) (PharmaManufacturing)
  • A Deep Look into the Supply Chain Issues of Africa (IRIN)
  • New Zealand Clarifies Pharmacovigilance Requirements for Drugmakers (FDAnews-$)

General Regulatory And Interesting Articles

  • Regulatory Affairs & Regulatory Operations: The Air Traffic Control Tower of Life Sciences (GxP Lifeline)
  • Deadly snakes 'milked' to create potent new anti-venom (Reuters)

Regulatory Reconnaissance #528 – 3 April 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.


Categories: Recon, Regulatory News

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