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.