Regulatory Reconnaissance (20 February 2013)

Posted 20 February 2013 | By Alexander Gaffney, RAC 

Good morning and welcome to another edition of Regulatory Reconnaissance. There are now just nine days between the US Food and Drug Administration and the effects of budget sequestration.

Top stories today include several looks at the effects of sequestration, two new private sector regulatory programs, a new batch of FDA warning letters, a new patent agreement in the EU, problems with clinical trials in India, a petition calling for clinical trials transparency gets a powerful supporter, and Pfizer's former head of drug development asks why Diclofenac is still on the market.


  • Noncompliant Use of Testimonials Remains Durable Feature of Supplements Business (Nutra Ingredients USA)
  • Will Sequester End Drug Approvals? Not Unless White House Wants it to (Forbes)
  • How The Sequester Could Affect Health Care (NPR)
  • Reports: Florida House subcommittee approves biosimilar-substitution bill (Drug Store News)
  • Almost one-third of chemotherapy used "off-label" (Reuters)
  • Opioid overdose deaths topped 16,000 in 2010 (Milwaukee Journal-Sentinel)
  • Webcast (9 am, 20 February): IOM Live Release of its PEPFAR Evaluation Report (IOM)
  • FDA Approval Rates up 7% in 2012 (Globe News Wire)
  • National Clinical Trials Network will Facilitate Research Recruitment in the US (Eye for Pharma)
  • AAMI Foundation's HTSI Launches New Coalition to Focus on Adverse Event Reporting (Infection Control Today)
  • Merck and Samsung Bioepis Enter Biosimilars Development and Commercialization Agreement (Merck)
  • FDA Has Submitted to OMB Revised Figured for Environmental Impact Assessment Reporting (FDA)
  • Recalling all lots of Reumofan Plus Tablets Due to Undeclared Drug Ingredients (FDA)
  • FDA Has Released the MedGuide for Pomalyst, an Analogue of Thalidomidie (FDA) (All MedGuides)
  • (Warning Letter - Device, Adulterated) Alcon LenSx, Inc (FDA)
  • (Warning Letter - Device, Clinical Trials) Solta Medical, Inc. (FDA)
  • (Warning Letter - Device, QSR/MDR) Medsys s.a. (FDA)
  • (Warning Letter - Device, Adulterated, Import Detention) Tan Extreme Inc (FDA)
  • Citizen Petition: FDA/CDER Response to Mutual Pharmaceutical Company, Inc. (Sidley Austin LLP) - Petition of Denial (FDA)
  • Citizen Petition: FDA/CFSAN Responds to Procter and Gamble Company Petition on Health Claims; Denied Due to Lack of Completeness (FDA)(Re-filed by Company)
  • 2013 Meeting Materials of the Neurological Devices Panel - NeuroPace (FDA)
  • Sanitas Gets FDA Clearance to Market 'Wellaho' Mobile Patient Support Platform (Xconomy)
  • INFOGRAPHIC: Business group points to 'tidal wave' of regulations (The Hill)
  • Industry Group Argues Parallel Importation is a "Disincentive for Developing World Access to Medicines" (BIO)
  • New rule helps small hospitals struggling with shortages (Fierce Pharma Manufacturing)
  • Psych Meds Often On Board in Opioid Overdoses (Med Page Today)
  • Feds Seize Supplements from Global All Wellness (Natural Products Insider)
  • FDA Reminds USPlabs of CGMP Duties (Natural Products Insider)
  • Meeting (20 February 2013): Launch of the Administration's Strategy to Mitigate the Theft of U.S. Trade Secrets (White House)
  • Gilead hepatitis C drug meets goal of fourth late-stage study (Reuters)
  • FDA accepts GSK's Anoro (Pharmafile)
  • Is The uBiome Project Performing Human Subjects Research Without IRB Approval? (Free Thought Blog Network)


  • Is India Losing Its Edge In Clinical Trials? (Pharmalot)
  • EU member states sign Unified Patent Court agreement (BioCentury)
  • AllTrials campaign shifts up a gear with NICE backing (Pharma Times)
  • INMETRO Certification Changes in Brazil (Emergo Group)
  • Meeting: "Regulation on Medical Devices (MDs) and In Vitro Diagnostic Medical Devices (IVDMDs)" (ENVI) (26 February 2013)
  • Committee for Veterinary Medicinal Products - focus on reducing the risk of antimicrobial resistance and strengthening quality assurance (EMA)
  • Recommendation on harmonising the approach to causality assessment for adverse events to veterinary medicinal products (EMA)
  • Reflection paper on pharmacovigilance communication concerning veterinary medicinal products (EMA)
  • China SFDA issues Technical Requirements for the Study of New Natural Medicines (SFDA)
  • India: System for the Pre-Screening of the Applications for Registration of Ethics Committees (CDSCO)
  • NICE now backs Oncotype with discount (BioCentury)
  • India to Open China Drug Inspection Office on 1 March 2013 (European Compliance Academy)
  • Takeda subsidiary suspended for 'no drug label' (BioSpectrum)
  • MEDEC Analysis: Increased Review Times at Health Canada (Emergo Group)
  • Changes to Medical Device Regulations in Argentina in Effect (Emergo Group)
  • Study Raises Doubts Over Robotic Surgery (WSJ) (Reuters)
  • NxStage wins nocturnal dialysis CE Mark (Mass Device)
  • Dune gains CE mark for next gen-breast cancer Dx tool (Fierce Medical Devices)
  • Australian Regulators Say They Are Aware of Reports of New Adverse Events Associated With Hip Replacement Systems (TGA)


Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

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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