Regulatory Focus™ > News Articles > Regulatory Reconnaissance (18 June 2013)

Regulatory Reconnaissance (18 June 2013)

Posted 18 June 2013 | By Alexander Gaffney, RAC

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

In Focus: US

  • Proposed Draft of House Compounding Legislation Released (FDA Law Blog) (Pink Sheet)
  • Outside Review of Clinical Data Finds a Medtronic's Spinal Treatment's Benefit Overstated (NYTimes) (Reuters) (WSJ) (Mass Device) (Bloomberg)
  • Big Pharma's Legal Bill To Take Hit From Pay-For-Delay Ruling (Law 360)
  • Philips Healthcare Issues Massive Class 1 Recall for Ventilator Due to Potential for Device Failure (FDA)
  • Amicus Delays U.S. Approval Filing for Fabry Disease Drug (The Street) (BioCentury) (SCRIP)
  • Opioid Generics Should Focus On Abuse-Deterrent Performance, Not Technology, FDA Says (Pink Sheet) (The Hill) (Testimony) (House)
  • Are regulatory and legal blocking pharma's social media marketing? (World of DTC Marketing)
  • Senate passes bill to allow research on organ transplants for HIV patients (The Hill)

In Focus: International

  • European Medicines Agency's Management Board endorses revised EMA Code of Conduct (EMA)
  • Health ministry may engage consultancy to review structure of CDSCO (PharmaBiz)
  • UK Developing Backup Plan to New European API Import Rules (FDA News)
  • France Releases Study of Last Decade of Antibiotic Use Data (ANSM)
  • Japan's MHLW To Set Up Rapid Evaluation System For Advanced Medical Technology And Pharmaceuticals (PharmAsia)

Comments? Suggestions? Email me at news@raps.org.

US

Pharmaceuticals/Biotechnology
  • Proposed Draft of House Compounding Legislation Released (FDA Law Blog) (Pink Sheet)
  • Amicus Delays U.S. Approval Filing for Fabry Disease Drug (The Street) (BioCentury) (SCRIP)
  • Durata Looks Beyond FDA: Reimbursement Changes May Offer Opening for Long-Acting Anti-infective (RPM Report)
  • Santarus and Pharming Announce FDA Acceptance for Review of RUCONEST (Recombinant Human C1 Esterase Inhibitor) Biologics License Application (Business Wire)
  • Opioid Generics Should Focus On Abuse-Deterrent Performance, Not Technology, FDA Says (Pink Sheet) (The Hill) (Testimony) (House)
  • New Citizen Petition Seeks Determination of Whether J&J's Paraflex (Chlorzoxazone) Was Withdrawn for Safety/Efficacy Reasons (FDA)
  • On Myriad: The Sky Isn't Falling (BioCentury)
  • FDA Approves ANDAs for Custopharm's Tranexamic Acid (#201580) and Alkem Labs' Lamotrigine (#200694) (FDA)
  • Lilly's pipeline failures concern analysts (IBJ)
  • MAPP: Regulatory Project Management Coordinating Committee (FDA)
  • AbbVie Targets Mylan In Latest Effort To Shield Norvir Patents (Law 360)
  • Merck, Pfizer Sue Mylan Over Generic Eye Drug Application (Law 360)
FTC vs. Actavis Reactions
  • Opinion recap: "Pay to delay" in deep trouble (SCOTUSblog)
  • Supreme Court Rules Drugmakers Can Be Sued For Pay-To-Delay Deals (Pharmalot)
  • Big Pharma's Legal Bill To Take Hit From Pay-For-Delay Ruling (Law 360)
  • Supreme Court decision on generics hits Actavis, but few other drug firms (Market Watch)
  • Supreme Court Rules in ANDROGEL Patent Settlement Agreement Case; Holds that Agreements are Subject to Antitrust Scrutiny, But Not Presumptively Unlawful (FDA Law Blog)
  • High Court Brings Economics Back To Pay-For-Delay Analysis (Law 360)
  • 'Father' of generic drug law applauds Supreme Court pay-to-delay decision (Philly Pharma)
  • SCOTUS: Antitrust applies in pay-for-delay, but gotta prove it (SCRIP)
Medical Devices
  • Outside Review of Clinical Data Finds a Medtronic's Spinal Treatment's Benefit Overstated (NYTimes) (Reuters) (WSJ) (Mass Device) (Bloomberg)
  • FDA OKs expanded trial for HeartWare's heart pump (Mass Device)
  • U.S. Bioterror Detection Program Comes under Scrutiny (Scientific American)
  • Philips Healthcare Issues Massive Class 1 Recall for Ventilator Due to Potential for Device Failure (FDA)
  • Cybersecurity for Medical Devices and Hospital Networks: FDA Safety Communication (FDA)
  • Delcath hit with investor lawsuit after FDA harangue (Fierce)
  • 2013 Meeting Materials of the Microbiology Devices Panel (FDA)
  • Diabetes: Echo Therapeutics sends pre-submission package to FDA for Symphony needle-free CGM (Mass Device)
Assorted and Government
  • Are regulatory and legal blocking pharma's social media marketing? (World of DTC Marketing)
  • Senate passes bill to allow research on organ transplants for HIV patients (The Hill)
  • Obesity Not a Disease, AMA Council Says (MedPage Today)
  • USPTO and the Obama Administration Taking Action to Improve Incentives for Future Innovation via High Tech Patents (USPTO)
  • Can new FDA graphic warning labels for tobacco pass a first amendment legal challenge? (EurekAlert)
Upcoming Meetings and Events
  • 17 June 2013: FDA Basics Webinar: Biological Products: Part 1 (FDA)
  • 18 June 2013: Understanding the Regulatory Landscape for Adaptive Design Trials (RAPS)
  • 18 June: NCATS to announce awards for Discovering New Therapeutic Uses for Existing Molecules program (NCATS)
  • 18 June 2013: Continuing Concerns Over BioWatch and the Surveillance of Bioterrorism (House)
  • 18 June 2013: Appropriations Committee Hearing on FDA (Senate)
  • 19-20 June 2013: Regulatory Education for Industry (REdI) Conference (FDA)
  • 21 June 2013: Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives Part 15 Public Meeting (FDA)
  • 24 June 2013: Science Board Meeting (FDA)
  • 25 June 2013: Meeting of the National Biodefense Science Board (DHHS)
  • 25-26 June 2013: Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (FDA)
  • 26 June 2013: General and Plastic Surgery Devices Panel of the Medical Devices Meeting (FDA)
  • 27 July 2013: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 29 June 2013: Clinical Development Programs for Opioid Conversion (FDA)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (FDA)

Europe

  • European Medicines Agency's Management Board endorses revised EMA Code of Conduct (EMA)
  • UK Developing Backup Plan to New European API Import Rules (FDA News)
  • France Releases Study of Last Decade of Antibiotic Use Data (ANSM)
  • PRAC recommends suspending marketing authorisations for infusion solutions containing hydroxyethyl-starch (EMA)
  • PRAC recommends restricting the use of codeine when used for pain relief in children (EMA)
  • IQWiG rebuffs Lyxumia for Type II diabetes (BioCentury)
  • IQWiG again rebuffs Caprelsa (BioCentury)
  • Single cancer registry announced for England (RPS)

Asia

  • Health ministry may engage consultancy to review structure of CDSCO (PharmaBiz)
  • Japan's MHLW To Set Up Rapid Evaluation System For Advanced Medical Technology And Pharmaceuticals (PharmAsia)
  • India Drug Regulator To Encourage Whistleblowers, Add To Port Testing (PharmAsia)
  • Generic Quality Assurance Topic At Japan's Chuikyo Drug Price Reform Meeting (PharmAsia)

Other International

General Regulatory and Interesting Articles

  • Forget Lab Rats: Testing Asthma Drugs on a Microchip (WSJ)
  • The Importance of Using A Cross-Functional Team Approach In Developing an Electronic Data Capture Database (Geeks Talk Clinical)

Regulatory Reconnaissance #90 - 18 June 2013

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.


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