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Regulatory News
13th February 2013
by Alexander Gaffney, RAC

Regulatory Reconnaissance (13 February 2013)

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


US

  • 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)

International

  • 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)

Interesting

  • 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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