Regulatory Focus™ > News Articles > Regulatory Reconnaissance (14 February 2013)

Regulatory Reconnaissance (14 February 2013)

Posted 14 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.

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

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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