Regulatory Focus™ > News Articles > Regulatory Reconnaissance (20-21 July 2013)

Regulatory Reconnaissance (20-21 July 2013)

Posted 19 July 2013 | By Alexander Gaffney, RAC 

Welcome to a special weekend edition of Regulatory Reconnaissance, Focus' regulatory news and intelligence briefing.

In Focus: US

  • FDA Discussing Guidance On Giving Drug Economic Data To Formulary Managers (Pink Sheet)
  • J&J's Simponi Aria approved for RA as it heads for blockbuster stratosphere (Fierce) (Pharma Letter)
  • mHealth oversight suggestions nearing end of the beginning (Government Health IT)
  • FDA Quality Profiling: Agency Hopes to Channel Corporate Attention (And Money) To Quality Systems (RPM Report)
  • PhRMA Criticizes Senate Drug Compounding Bill As Others Also Take Sides (IHP)

In Focus: International

  • EMA's PRAC Turns One Year Old (EMA)
  • European Medicines Agency publishes agenda for workshop on conflicts of interests (EMA)
  • Japan green-lights trial of stem cell therapy for eye disease (Fierce)

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

US

Pharmaceuticals/Biotechnology
  • FDA Discussing Guidance On Giving Drug Economic Data To Formulary Managers (Pink Sheet)
  • FDA Quality Profiling: Agency Hopes to Channel Corporate Attention (And Money) To Quality Systems (RPM Report)
  • FDA Withdraws Compliance Policy Guide on the Use of Units of Plasma and Fresh Frozen Plasma Which have been Thawed (FDA)
  • PhRMA Criticizes Senate Drug Compounding Bill As Others Also Take Sides (IHP)
  • FDA Approves ANDA for Anchen Pharmaceuticals' Fenofibrate Choline (Trilipix, #201573) (FDA)
  • Sun Pharma recalls brain hemorrhage treatment drug in US (India Times)
  • J&J's Simponi Aria approved for RA as it heads for blockbuster stratosphere (Fierce) (Pharma Letter)
  • U.S. Congress Moves Closer to Lifting Ban on Transplanting Organs From HIV-Positive Donors (Science Magazine)
  • AbbVie Hits Roxane With Patent Suit Over Norvir (Law 360)
Medical Devices
  • mHealth oversight suggestions nearing end of the beginning (Government Health IT)
  • Takeda, Zinfandel Pharma Say Their Genetic Biomarker Test for Alzheimer's is Comparable to Cerebrospinal Fluid-Based Biomarkers (Takeda)
Assorted And Government
  • FDA Uses Web Tool to Better the Odds for Food Safety (FDA)
Upcoming Meetings And Events
  • 22-23 July 2013: Arthritis Advisory Committee Meeting (FDA)
  • 23 July 2013: Meeting: Current Cardiac Risk Paradigm: Arrhythmia Risk Assessment During Drug Development without the Thorough QT Study (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)
  • 25 July 2013: CBER Webinar on its Direct Recall Classification Program (FDA)
  • 25-26 July 2013: Meeting on Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (FDA)
  • 31 July 2013: Nonprescription Drugs Advisory Committee Meeting  (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • EMA's PRAC Turns One Year Old (EMA)
  • European Medicines Agency publishes agenda for workshop on conflicts of interests (EMA)
  • New law in France could facilitate human embryo research (MedCity News)
  • U.K. pharma group's cannabis-based diabetes drug sparks insulin output (Fierce) (Bloomberg)
  • New drug driving offence will affect patients taking controlled drugs (PJO)

Asia

  • Japan green-lights trial of stem cell therapy for eye disease (Fierce)
  • GSK sends contingent to China, even as country prevents one exec from leaving (Fierce)

General Regulatory And Interesting Articles

  • Microbe found on Calif. beach kills anthrax, scientists say [Video] (CBS)
  • Medicines To Fight White Plague Are Losing Their Punch (NPR)

Regulatory Reconnaissance #112  - 20-21 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.


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe