Regulatory Focus™ > News Articles > Regulatory Reconnaissance (26 June 2013)

Regulatory Reconnaissance (26 June 2013)

Posted 26 June 2013 | By Alexander Gaffney, RAC

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

In Focus: US

  • Diamond Jubilee: The Federal Food, Drug, and Cosmetic Act Turns 75! (FDA Law Blog)
  • FDA, NIH Devise Regulatory Research Agenda, Look for Financing (Pink Sheet) (MedPage Today) (NIH)
  • CBER's Product Review Branch Searching for New Chief (FDA)
  • CEO of American Medical Device Company Held Hostage in China (MDDI)
  • FDA Sues NJ Compounder Over Mold-Contaminated Products (Law 360)
  • Court Records: Bard Used Mesh Plastic Found Unfit for Humans by Supplier (Bloomberg)
  • FDA Blocks Medtronic Catheters, Cites Manufacturing Violations at Italian Facility (Mass Device) (Law 360)
  • The FDA's Science Board Subcommittee to Help Agency Improve Device Branch (Mass Device)
  • Obama Administration Threatens Veto of House FDA Appropriations Bill (Agri Pulse) (BioCentury)
  • New Warning Letters Posted (FDA)

In Focus: International

  • China, Taiwan Begin Shift to Regulatory Convergence (In-Pharma Technologist) (SCRIP)
  • Ranbaxy Gets Rare Good News: Court Tosses Sensational Lawsuit (Pharmalot)
  • Ranbaxy CEO: All Change at the Top And No FDA Mohali 'Show-Stopper' (SCRIP)
  • China Needs More Drug Regulatory Legal Staff: Tsinghua University Conference (PharmAsia)
  • Aussie House Passes Public Access Bill For Branded Drugs, Gene Tests (PharmAsia)
  • Avanir's Nuedexta Approved for PBA in Europe (Pharma Letter)

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

US

Pharmaceuticals/Biotechnology
  • FDA, NIH Devise Regulatory Research Agenda, Look For Financing (Pink Sheet) (MedPage Today) (NIH)
  • CBER's Product Review Branch Searching for New Chief (FDA)
  • US drugmaker MSD gets interim relief on diabetes drug patent row (India Times)
  • FDA Sues NJ Compounder Over Mold-Contaminated Products (Law 360)
  • Impax to get new CEO as it tries to right manufacturing, regulatory issues (Fierce)
  • Two Compounding-Related Form 483s Posted (FDA) (FDA)
  • Janet Woodcock on FDA's New Breakthrough Designation Guidance (FDA)
  • FDA Expedited Programs Guidance: "Available Therapies" Depends On U.S. Standard Of Care (Pink Sheet)
  • What's a breakthrough therapy? FDA explains (SCRIP)
  • Where were the breakthrough drugs for diabetes at ADA? (Fierce)
  • FDA Approves Efficacy Supplements for Shire's Idursulfase ANDA (#125151) (FDA)
  • Globalisation of Manufacturing and Distributing Medicinal Products Causing Troubles according to the FDA (IPQ)
  • Quality, Manufacturing Transparency Key to Avoiding Biologic Drug Shortages (Safe Biologics)
  • Results of new meta-analysis regarding CV events in linagliptin Phase 3 trials presented at ADA (Boehringer Ingelheim)
  • Novartis' omalizumab effective for severe hives (Pharma Times)
  • More Breaking Preemption News (Drug and Device Law)
Pharmaceuticals: General
  • Increased prescription drug use reduces spending on medical services (Healthcare Economist)
  • Top Medicare Official: 'We Can and Should Do More' to Oversee Drug Plan (ProPublica)
  • Most Common Reason For Poor Rx Adherence: "I Forgot" - NCPA (Pink Sheet)
  • Basilea lands BARDA bioterrorism contract worth up to $89m (SCRIP) (BioCentury)
Medical Devices
  • Court Records: Bard Used Mesh Plastic Found Unfit for Humans by Supplier (Bloomberg)
  • FDA blocks Medtronic catheters, cites manufacturing violations at Italian facility (Mass Device) (Law 360)
  • The FDA's Science Board subcommittee to help agency improve device branch (Mass Device)
  • Medtronic Recalling all SynchroMed Pumps Due to Unintended Drug Delivery (FDA) (FDA) (FDA) (FDA)
  • EnteroMedics submits PMA for obesity therapy to FDA (BioCentury)
  • CEO of American Medical Device Company Held Hostage in China (MDDI)
  • FDA Panel Will Consider Increased Regulation Of Blood Lancets (FDA) (Gray Sheet)
  • First-of-its-kind Report Provides Global Outlook on Patient Privacy in Mobile Health (mHealth Alliance)
  • Final days of waiting for FDA mobile medical app guidance? (Mobi Health News)
  • EnteroMedics files with FDA despite obesity-device trial flop (Fierce)
  • Rhythmlink First to Receive FDA Clearance for Disposable MR Conditional Cup Electrodes (Rhythmlink)
  • BioFire Receives FDA Clearance for the FilmArray Blood Culture Identification Panel (BioFire)
  • Aethlon Medical Announces FDA Approval of IDE to Treat Hepatitis C (HCV) Patients (Aethlon)
  • Six Steps to Stop Medical Device Hackers (Qmed)
  • Minnesota feds probe Medtronic over Trade Agreements Act (Mass Device)
Assorted And Government
  • Diamond Jubilee: The Federal Food, Drug, and Cosmetic Act Turns 75! (FDA Law Blog)
  • Obama administration threatens veto of House FDA appropriations bill (Agri Pulse) (BioCentury)
  • New Warning Letters Posted (FDA)
  • OMB Clears FDA Information Request on Electronic Reporting of Adverse Events (OMB)
  • Ed Markey, Congressman Now Influential in FDA Matters, Wins Race for Senate Seat Vacated by John Kerry (Huffington Post)
  • DHHS to Hold Meeting on Matters Related to the Protection of Human Subjects and Research Studying Standard of Care Interventions (DHHS)
  • Panel aims to debunk 'anti-regulatory myths' (The Hill)
  • S.1180 -- Medicare Data Access for Transparency and Accountability Act (Senate)
  • FDA publishes guidance for Good Manufacturing Practices for Cosmetics (Cosmetics Design)
Upcoming Meetings And Events
  • 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) (Materials)
  • 27 July 2013: Gastroenterology And Urology Devices Panel Of The Medical Devices Advisory Committee Meeting (FDA) (Materials)
  • 27 June 2013: Mobile Medical App Entrepreneurs: Changing The Face Of Health Care (House)
  • 27 June 2013: A Tangle Of Trade Barriers: How India's Industrial Policy Is Hurting U.S. Companies (House)
  • 29 June 2013: Clinical Development Programs For Opioid Conversion (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • Here Comes The Sunshine Act - This Time, In Europe (Law 360)
  • Thrown in at the deep end: MEP Rebecca Taylor on the IVD Regulation (Clinica)
  • France Issues New Report on Combined Oral Contraceptives (ANSM)
  • Avanir's Nuedexta approved for PBA in Europe (Pharma Letter)
  • NICE completes Forxiga U-turn (Pharmafile)

Asia

  • China, Taiwan Begin Shift to Regulatory Convergence (In-Pharma Technologist)
  • More to come as China-Taiwan build pharma bridges (SCRIP)
  • Ranbaxy Gets Rare Good News: Court Tosses Sensational Lawsuit (Pharmalot)
  • Ranbaxy CEO: All change at the top and no FDA Mohali 'show-stopper' (SCRIP)
  • China Needs More Drug Regulatory Legal Staff: Tsinghua University Conference (PharmAsia)
  • India Fixes Prices of 40 Additional Drugs Under New DPCO (PharmaBiz) (PharmaBiz)

Other International

  • Aussie House Passes Public Access Bill For Branded Drugs, Gene Tests (PharmAsia)
  • Martin Cross is new chair of Medicines Australia (BioSpectrum)
  • TGA: Reclassification of hip, knee and shoulder joint replacement implants: advice from orthopaedics working group meeting (TGA)

General Regulatory And Interesting Articles

  • What are Life Science Companies Doing on Twitter? (Eye on FDA)

Regulatory Reconnaissance #96 - 26 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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