Regulatory Reconnaissance (11 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

• Triclosan: Anti-bacterial soaps called useless, potentially dangerous (Chicago Tribune)
• FDA Convenes Hearing on Pain-Pill Labels (WSJ)
• Pain Groups Give FDA Opioid Panel Alternatives to Label Changes (Med Page Today)
• Defender Or Opponent? Amgen Straddles The Biosimilar Line (Pink Sheet Daily) ($)
• Amgen gives biosimilars guidance (BioCentury)
• One Down, 13 To Go: A Biosimilar Bill Falls Flat (Pharmalot)
• FDA Talking To Industry About Releasing "Complete Response" Letters (The Pink Sheet) ($)
• FDA rebuff deals big blow to Novo Nordisk's U.S. hopes (Reuters)
• FDA warns of dangerous software malfunction with Hamilton ventilators (FierceMedicalDevices)
• FDA Questions Whether Raw Deal's Products are Dietary Supplements (Natural Products Insider)
• Did Sperm and Egg Donors Unwittingly Contribute to NIH-Approved Stem Cells? (Science Insider)
• Supplement-Related Adverse Events Underreported, FDA Says (Natural Products Insider)
• Meningitis outbreak prompted electronic access to patient records (Modern Healthcare)
• Study Seeks Biomarkers for PTSD and Traumatic Brain Injuries (NYTimes)
• Florida Pharmacy Guilty in New York Inquiry Into Steroid Sales (NYTimes)
• US pharmaceutical exports to Iran cut in half in 2012 (Reuters)
• The Changing Landscape of Postmarketing Safety Reporting (Ask Cato)
• Why NMEs and Therapeutic Biological Products Fail in the First FDA Review Cycle (RPM Report) ($)
• Medical research grants drop with threat of sequestration (Federal Times)
• GVB BIO licenses biomarker database to FDA (Center Watch)
• EU, US Fully Implement Mutual Trade Recognition Decision (CBP)
• Ruling paves way for state pharmaceutical suits (MedCity News)
• Guard shoots at boy, 15, at FDA office in Bothell (Seattlepi)
• Mystery: Contracted FDA Guard Opens Fire on 15-Year-Old Boy (TheBlaze)
• Opinion:The FDA's Magic Meeting (Placebo Control)
• Opinion: Antibiotic Resistance and Agency Recalcitrance (Center for Progressive Reform)

International

• Uncertainties Abound in Indian Draft Clinical Trial Amendment (Outsourcing Pharma)
• Planning Commission calls for steps to strengthen regulatory systems in Indian States (PharmaBiz)
• India's drug alert system picks up momentum (PharmaBiz)
• MHRA 'concern' over unlicensed drug sales in UK (Pharma Times)
• China Sentences 7 to Prison for Toxic Gel Capsules (Pharmaceutical Processing)
• German agencies proposal to tackle nanomaterials in REACH (Cosmetics Design Europe)
• Fake TB drugs linked to rising resistance (Securing Industry)
• EU Parliament sets 90 days for pricing generics (BioCentury)

General Regulatory

• The Most Powerful Case for Vaccines You'll Ever See (Imgur)
• Record-High Antibiotic Sales for Meat and Poultry Production (Pew)
• GSK vaccine ingredient scrutinized for narcolepsy clues (Reuters)
• Psychiatric drugs tied to falls in the elderly (Reuters)
• Acetaminophen Deaths Fall with Smaller Bottles (Med Page Today)