Regulatory Focus™ > News Articles > Regulatory Reconnaissance (13 February 2013)

Regulatory Reconnaissance (13 February 2013)

Posted 13 February 2013 | By Alexander Gaffney, RAC

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe.


  • FDA Convenes 'Message Fatigue' Panel (Medpage Today)
  • Public Workshops: Global Quality Systems--An Integrated Approach to Improving Medical Product Safety (FDA)
  • Under OMB Review: "Guidance for Industry and Food and Drug Administration Staff; Center for Devices and Radiological Health Appeals Processes" (FDA)
  • Meetings: Annual Computational Science Symposium (FDA)
  • Furloughs likely would exceed 1 million; feds feel 'undervalued, unappreciated' (Washington Post)
  • House Rules Committee to explore biennial budget process (The Hill)
  • FDA's Adverse Event Reporting System (FAERS) Finds Three Drugs With Potential Risks in Q3 2012 (FDA)
  • Mini-Sentinel Expanding Drug Safety Efforts To Prospective Surveillance (The Pink Sheet)
  • Disclosures To Participate in State Prescription Drug Monitoring Programs (VA)
  • How Many People Participate In Medical Research? (Pharmalot)
  • 'Fast' Progress: Ampligen Activist Ends Hunger Strike (BioWorld)
  • The US Pharmacopoeia Has Been Re-Certified as a Global Standards-Setting Organization by ISO (USP)
  • Amgen ditches PhIII study plans for bone-healing drug as regulatory bar rises (Fierce Biotech)
  • FDA's Plan for Speeding 510(k)s: Triage for 90 Day Decisions (MDDI)
  • Philly U.S. Attorney: Caronia court decision won't impact pharma prosecutions (locally, for now) (Philadelphia Inquirer)
  • Everything You Need to Know About Priority Review Vouchers: Part 1 of 2 (Ask Cato)
  • More Breakthrough Designation Product Sponsors Determined: Pharmacyclics and Johnson & Johnson (J&J)
  • FDA Approves Actos ANDA Before Exclusivity Expires; Shared 180-Day Awards At Risk? (The Pink Sheet Daily)
  • St Jude recalls wire used to help plug hole in heart (Reuters)
  • Dispute Develops Over 340B Discount Drug Program (NYTimes)


  • Parliamentary panel recommends bringing of CDSCO under Dept of Pharmaceuticals (PharmaBiz)
  • Indian Pharma companies may share essential drugs production details with govt (Economic Times)
  • Exporters upset over govt's delay in convincing EU to accept Indian GMP on par with EU CGMP (PharmaBiz)
  • RS panel to visit Hyderabad, Mumbai to probe charges of prevalence of spurious drugs (PharmaBiz)
  • Notice to Stakeholders - New name for the Post-Market Reporting Compliance (PMRC) inspection program to Good Pharmacovigilance Practices (GVP) (Health Canada)
  • Inspection Strategy for Good Pharmacovigilance Practices (GVP) for Drugs (Health Canada)
  • Risk Classification of Good Pharmacovigilance Practices (GVP) Observations (Health Canada)
  • Good Pharmacovigilance Practices (GVP) Guidelines (Health Canada)
  • Opioid prescription is on the increase in Germany (EurekAlert)
  • NICE rejects Jakavi (Pharmafile)


  • Name-brand or generic? Your political ideology might influence your choice (EurekAlert)
  • Two Medical Societies Break New Ground To Test Medical Device (Forbes)
  • Cancer, Innovation and a Boy Named Jack (Forbes)
  • Patients At Risk From Inaccurate Antibiotic Test Kits, Warns BMJ Investigation (Medical News Today)
  • World's Most Popular Painkiller Raises Heart Attack Risk (NPR)

Did we miss a story? Send us a tweet at @RAPSorg or @AlecGaffney and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance.

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