Regulatory Reconnaissance (14 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 Skeptical of MRI Contrast Agent in Babies (Medpage Today)
• Botulism Agent Gets Thumbs Up from FDA Panel (Medpage Today)
• Live Webcast: International Regulatory Harmonization Amid Globalization of Biomedical Research & Medical Product Development (IOM)
• FDA Reveals More Info on API File Submissions (In Pharma Technologist)
• Rx-to-OTC switches could be boon as FDA looks at switch paradigm (Drug Store News)
• Supplements' GMP Problems Red Flag Other Regulatory Issues (Natural Products Insider)
• FDA Approves Second Generation MRI-Friendly Pacemaker System From Medtronic (Forbes) (Medtronic)
• New England Compounding Center expected record profits before raid (WCVB TV)
• Obama Medicare rebate plan could hurt drug companies (Reuters)
• Girl who lost most of her skin awarded $63 million in Motrin lawsuit (Cleveland Plain Dealer)
• Obama targets drug companies, supports NIH (BioCentury)
• PhRMA slams 'radical' proposal on drug pricing in Obama's SOTU (The Hill)
• Colorado Biosimilar Bill Passes A Key Hurdle (Pharmalot)
• Lantheus: 'Supplier Diversification' Strategy After Ben Venue Shutdown (Outsourcing Pharma)
• FDA returns to Hospira plant for crucial re-inspection (Fierce Pharma)
• Hospira gets FDA notice over medical device problems (Reuters)
• CDMO Sovereign takes it on the chin in FDA warning letter (Fierce Pharma Manufacturing) (Warning Letter)
• FDA Warning Letter to PA Benjamin Manufacturing Co, Ltd (Warning Letter)
• Podcast: OIG's Sarah Langford on the Agency's Report, "REMS Plans Assess Risky Drugs" (OIG)
• Patients victims of untested medical devices (San Francisco Chronicle) (Fierce Medical Devices)
• Attorneys: J&J knew of mesh problems before marketing (Fierce Medical Devices)
• GAO Report: State Approaches Taken to Control Access to Key Methamphetamine Ingredient Show Varied Impact on Domestic Drug Labs (GAO)
• Does Health IT Safety Need New Regulatory Body? (Information Week)
• Is FDA Moving Quickly Enough to Regulate DMAA? (NYTimes)
• US Drug prices jump again while other health costs decline (USA Today)

International

• Slow approvals put India's drug trials industry at risk (Reuters)
• Planning Commission recommends interlinking of all drug licensing offices, labs (PharmaBiz)
• EU and US free-trade talks launched (BBC)
• PhRMA and EFPIA Applaud Push for EU-US Trade Agreement (PhRMA/EFPIA)
• Professor Stuart Ralston confirmed as new Chair of the Commission on Human Medicines (MHRA)
• Spanish cost curbs: pharma sales down 15% over two years (Pharma Times)
• EMA Recruiting for New Head of Unit, Development and Evaluation (LinkedIn)

Interesting

• 6 Tips for Mitigating Manufacturing Risk (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.