Regulatory Reconnaissance (12 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 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• FDA To Issue UDI Database Draft Guidance In March (The Gray Sheet)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)

International

• 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)

Interesting

• 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.