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

Regulatory Reconnaissance (18 July 2013)

Posted 18 July 2013 | By Alexander Gaffney, RAC 

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

In Focus: US

  • Supplement GMP Problems Could Yield Park Cases (Pink Sheet)
  • With a complete redesign and a new quality program, J&J hopes Fort Washington plant can reopen (MedCity News) (Fierce)
  • J&J Pays $23M To Settle Class Action Suit Over OTC Troubles (Pharmalot)
  • PPD's Monitoring of Eliquis Trials 'Adequate' says US FDA (Outsourcing Pharma)
  • House Inches Toward Oversight of Compounding (MedPage Today)
  • Novartis Under Investigation Over MS Drug Marketing (Law 360)
  • Chelsea Northera gets 2nd chance at FDA (SCRIP) (BioCentury)
  • Breast Implants: The View From the FDA (Medscape)
  • Myriad: Marching in on BRCA test patents would be 'inappropriate' (SCRIP) (Patent Docs)
  • Lawsuit Highlights Long-Dormant FDA Medical Food Issues (IHP)

In Focus: International

  • European Medicines Agency welcomes new Head of Legal Service (EMA)
  • China regulators pledge new crackdown on counterfeit drug operations (Fierce)
  • Will the Asian Clinical Trial Boom Turn to Bust? (Outsourcing Pharma)
  • China Pharma Awaits 15 Drug Patent Expirations In 2013 (PharmAsia)
  • MSD Japan head: Regulatory bodies are purposely delaying approvals (BioSpectrum)
  • GlaxoSmithKline's Andrew Witty on Fixing Big Pharma's Bad Boy (Bloomberg)

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

US

Pharmaceuticals/Biotechnology
  • Supplement GMP Problems Could Yield Park Cases (Pink Sheet)
  • With a complete redesign and a new quality program, J&J hopes Fort Washington plant can reopen (MedCity News) (Fierce)
  • J&J Pays $23M To Settle Class Action Suit Over OTC Troubles (Pharmalot)
  • PPD's Monitoring of Eliquis Trials 'Adequate' says US FDA (Outsourcing Pharma)
  • House Inches Toward Oversight of Compounding (MedPage Today)
  • Novartis Under Investigation Over MS Drug Marketing (Law 360)
  • Rx manufacturer vs compounder: Where to draw the lines (SCRIP) (IHP)
  • Compounder Definition In House Bill May Use Blended Metrics (Pink Sheet)
  • New Radiation Therapy Xofigo Prolongs Prostate Cancer Survival (NYTimes) (Pharma Letter)
  • Chelsea Northera gets 2nd chance at FDA; shares up (SCRIP) (BioCentury)
  • FDA Approves ANDAs for Watson's Lamotrigine (#200828) and Glenmark's Acamprosate Calcium (#202229) (FDA)
  • Novartis' Serelaxin Poised For Standard FDA Review (Pink Sheet)
  • FDA Grants Fast Track Designation to Adynxx Lead Compound AYX1 (Adnyxx)
  • FDA Grant Fast Track Designation to ELND005 for the Treatment of Neuropsychiatric Symptoms in Alzheimer's Disease (Elan) (Medical Daily) (PMLive)
  • Transition Therapeutics' Alzheimer's drug gets FDA fast-track status (Reuters)
  • Citizen Petition: Amedra Pharmaceuticals Asks FDA Not to Approve Generic Albenza (Docket)
  • Regulation of Drugs for Early Alzheimer's Disease: Not Enough? (NEJM)
  • Celgene Will Discontinue Phase III ORIGIN Trial in Previously Untreated Elderly Patients with B-Cell Chronic Lymphocytic Leukemia (Celgene)
Pharmaceuticals: General
  • Who Should Administer .Pharmacy Domain Names? (Pharmalot)
Medical Devices
  • Breast Implants: The View From the FDA (Medscape)
  • Study Slams Online Alzheimer's Tests (MedPage Today)
  • Myriad: Marching in on BRCA test patents would be 'inappropriate' (SCRIP) (Patent Docs)
  • GE wins CE Mark for low-radiation 3D breast imaging (Mass Device)
  • Sologrip III Laser Fiberoptic Delivery Device for Minimally Invasive Transmyocardial Revascularization FDA Cleared (MedGadget)
Assorted And Government
  • Research Underscores Need For New Pain Measures In Clinical Trials (IHP)
  • Lawsuit Highlights Long-Dormant FDA Medical Food Issues (IHP)
  • In Case You (Like Everyone) Missed It - The Administrative Conference of the United States is Back (FDA Law Blog)
  • ACRP Applauds FDA Expanded Access Guidance (Docket)
  • Hospitals, drug firms, device makers win with Obamacare, analyst says (Market Watch)
  • FTC Releases Draft Strategic Plan for Fiscal Years 2014-2018 (FTC)
  • JAMA Drops Requirement for Independent Statistical Analysis for Industry Funded Trials (Policy and Medicine)
  • Senate Committee Urges National Toxicology Program "to be Highly Precise" (NPI)
  • H.R.2696 -- To increase transparency of agencies by requiring a report describing any proposed conference. (Congress)
  • Regulatory: The dos and don'ts of corporate internal investigations, Part 6 (Inside Counsel)
Upcoming Meetings And Events
  • 16 July 2013: Hearing: Reforming the Drug Compounding Regulatory Framework (House)
  • 18 July 2013: Meeting: Dental Products Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 18 July 2013: Meeting: Anesthetic and Analgesic Drug Products Advisory Committee (FDA)
  • 22-23 July 2013: Arthritis Advisory Committee Meeting (FDA)
  • 23 July 2013: Brookings Webinar: Active Medical Product Surveillance Roundtable (FDA)
  • 24 July 2013: House Hearing on US-EU Free Trade Agreements and Regulatory Barriers (House)
  • 31 July 2013: Nonprescription Drugs Advisory Committee Meeting  (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • European Medicines Agency welcomes new Head of Legal Service (EMA)

Asia

  • China regulators pledge new crackdown on counterfeit drug operations (Fierce)
  • Will the Asian Clinical Trial Boom Turn to Bust? (Outsourcing Pharma)
  • China Pharma Awaits 15 Drug Patent Expirations In 2013 (PharmAsia)
  • GSK Roundup: Kin Of Ousted Party Official Works For GSK, Suggesting Politics In Probe (PharmAsia)
  • MSD Japan head: Regulatory bodies are purposely delaying approvals (BioSpectrum)
  • Japan Science And Technology Agency Proposes News IP Strategy (PharmAsia)
  • Questions linger as Novartis, university look to move past Japan Diovan affair (SCRIP)

Other International

  • GlaxoSmithKline's Andrew Witty on Fixing Big Pharma's Bad Boy (Bloomberg)

General Regulatory And Interesting Articles

  • Neuro Trials Often Based on Shaky Evidence (DD&D)
  • Injectable 'smart sponge' holds promise for controlled drug delivery (EurekAlert)
  • Glucose Sensing Sponge Delivers Insulin Precisely When and Where Needed (MedGadget)
  • New Surgical Knife Can Instantly Detect Cancer (AP) (Reuters)

Regulatory Reconnaissance #110  - 18 July 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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