Regulatory Focus™ > News Articles > Regulatory Reconnaissance (29 July 2013)

Regulatory Reconnaissance (29 July 2013)

Posted 29 July 2013 | By Alexander Gaffney, RAC

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

In Focus: US

In Focus: International

  • CHMP Releases Approval Recommendations from Most Recent Meeting (CHMP)
  • EU Releases Reports on the State of Rare Disease Activities (EUCERD)
  • France Warns Physicians About Cases of Necrotizing Fascitis from use of Avastin (ANSM)
  • UK pharma shows signs of dangerous addiction to bribery (Guardian)
  • Latest Round Of TPP Talks End Without Resolving Drug Patent Extension Issues (PharmAsia)
  • New Zealand Pharmaceutical industry bodies plan to merge (NZHerald)

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

US

Pharmaceuticals/Biotechnology
Pharmaceuticals: General
  • US drugmaker Perrigo to buy Ireland's Elan for $8.6bn (Guardian) (Fierce) (SCRIP) (Bloomberg)
  • Pfizer Signs New Agreement With UNICEF To Supply A Total Of Up To 740 Million Doses Of Prevenar 13* For The World's Poorest Countries Through 2025 (Pfizer) (AP)
  • GSK adds to its commitment to GAVI Alliance to help protect millions more children against infectious diseases (GSK)
  • BioCenturyTV: How do you get Rare Disease Treatments Paid For? (BCTV)
Medical Devices
  • Coalition Proposes FDA Regulatory Framework For Clinical-Decision Support (Gray Sheet)
  • Medicare Change Heralds Easier Device Trial Reimbursements (Law 360)
  • Medical device hacking expert dies before releasing pacemaker exploit (Mass Device)
Assorted And Government
  • FDA has adequate enforcement authority, sources say in reaction to Driven Sports exposé (Nutra-Ingredients)
  • FDA warns on vitamin supplement containing steroids, cites risks (Reuters) (NBC) (FDA) (FDA)
  • Regulatory Legislation to see House Vote This Week (House)
  • SCRIP's Capitol Capsule (SCRIP)
  • Harvard Pilgrim sued for not covering compounded drugs (Fierce)
Upcoming Meetings And Events
  • 25-26 July 2013: Meeting on Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (FDA)
  • 29 July 2013: Workshop on Clinical Development Programs for Opioid Conversion (FDA)
  • 30-31 July 2013: Workshop on Battery-Powered Medical Devices (FDA)
  • 31 July 2013: Nonprescription Drugs Advisory Committee Meeting  (FDA)
  • 2 August 2013: Blood Products Advisory Committee Meeting (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • EU Releases Reports on the State of Rare Disease Activities (EUCERD)
  • Boehringer nears European approval for first cancer drug (Pharmafile)
  • France Warns Physicians About Cases of Necrotizing Fascitis from use of Avastin (ANSM)

CHMP Roundup

Asia

  • UK pharma shows signs of dangerous addiction to bribery (Guardian)
  • GlaxoSmithKline China scandal: another 18 people arrested (Guardian)
  • Latest Round Of TPP Talks End Without Resolving Drug Patent Extension Issues (PharmAsia)
  • Indian Health Min to take a final call on lifting ban on analgin, deanxit soon (PharmaBiz)
  • ExAblate Receives Approval of Chinese Food and Drug Administration (InSightec)

Other International

  • New Zealand Pharmaceutical industry bodies plan to merge (NZHerald)
  • Were Four Australian Soccer Players Enrolled in a Secret Clinical Trial? (The Australian)

General Regulatory And Interesting Articles

  • Devices Keep Tots from Chugging Liquid Meds (MedPage Today)
  • Dangerous Liaisons: Terrorism and Pharma (PharmExec)

Regulatory Reconnaissance #119  - 29 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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