Regulatory Reconnaissance (12 February 2013)

Posted 12 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 May Change Warning Regs For Generic Labels (Pharmalot)
  • Representative Jack Kingston, Chair of DHHS Appropriations, Says Sequestration is Going to Happen (BioCentury)
  • FDA To Issue UDI Database Draft Guidance In March (The Gray Sheet)
  • Mobile apps help docs prevent drug-related errors (Mass Device)
  • AHRQ Comparative Effectiveness Strategy Could Shift As Director Clancy Steps Down (The Gray Sheet)
  • FDA's Katz Retires from Agency-So Who's Next? (Drugwonks) (The Pink Sheet Daily)
  • Health law rule on 'essential benefits' sent to White House for final review (The Hill's RegWatch)
  • Meet the New Medical Device on the Block. His Name is Watson. (IBM) (PMLiVE)
  • The Supply Chain Provisions Of The FDA Safety & Innovation Act (RxTrace)
  • Court shuts down U.S. operations of California drug, dietary supplement manufacturer (FDA)
  • Function Over Form or Form Over Function? Two Petitions Challenge FDA's NCE Exclusivity Approach for Combination Drugs (FDA Law Blog)
  • Improving the Utility and Translation of Animal Models for Nervous System Disorders - Workshop Summary (IOM)
  • The State of Drug Safety Surveillance in the U.S.: Much Improved, More to Come (Brookings)
  • Vitamin D content of supplements 'varies widely', says new analysis (Nutra Ingredients USA) (Medscape)
  • Fueled by Pain Pills, Drug Overdose Deaths Triple in NYC Between 1990 and 2006 (NY Times)
  • Pro-regulation groups urge Obama to call for additional rules (The Hill)
  • Report: President to propose 1% pay raise for feds, FDA (Federal Times)
  • Class 1 Recall of St Jude Medical's Amplatzer TorqVue Delivery System (FDA)


  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 February 2013 (EMA)
  • Pharmacovigilance Risk Assessment Committee (PRAC) invites stakeholders' feedback in review of Diane 35 and its generics (EMA)
  • Canadian Module 1 Schema Version 2.2 (extension of deadline) (Health Canada)
  • Japan's regulators push for quicker device approval process (Fierce Medical Devices)
  • Drugmakers, academics pool R&D in $265 mln EU project (Reuters)
  • Drugmakers eye Africa's middle classes as next growth market (Reuters)
  • DCGI meets stakeholders at CDSCO West zone office to address issues (Pharma Biz)


  • Is there a cure for corporate crime in the drug industry? (BMJ)
  • In research, it matters whether you're a man or a mouse (Science News)
  • Predevelopment Tasks for Drug Making (Pharma Manufacturing)

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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