Regulatory Focus™ > News Articles > Regulatory Reconnaissance (11 February 2013)

Regulatory Reconnaissance (11 February 2013)

Posted 11 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

  • 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

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)
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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