Regulatory Reconnaissance (8 May 2013)

Posted 08 May 2013 | By Alexander Gaffney, RAC 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

In Focus: International

  • GlaxoSmithKline's 'independent experts' start to hand out keys to its data vault (Fierce Biotech) (GSK) (Pharma Times) (PMLive) (Pharmalot)
  • Dagmar Roth-Behrendt reaches for higher goals, won't run for Re-Election as MEP (Clinica)
  • Canadian Health Officials Hushed Drug Research on Safety of Antipsychotics, Suit Says (Law 360) ($) (Pharmalot)
  • Philippines Embraces Harmonized Postmarketing Alert System (FDA News) ($)
  • Review sets benchmark for short-term toxicity studies (Pharma Times) (NC3R)

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  • Judge in NYC Rips Opposition to Plan B Order, Hamburg Cites Troubling Precedent (AP) (Reuters) (WSJ) (CBS) (The Hill)
  • Clinical Success Rates for New Cancer Drugs Doubled from the Mid-1990s to Early-2000s (Tufts)
  • Sources Sought: Investigation of inequivalence of bupropion hydrochloride extended release tablets: in vitro metabolism quantification (FDA)
  • FDA Sends out PDUFA Invoices to Industry (FDA)
  • FDA widens fast-track scope for Cubist antibiotic (Boston Herald) (Business Wire)
  • FDA grants Breakthrough Therapy Scioderm's SD-101 for epidermolysis bullosa (CenterWatch)
  • Declaring Victory: How FDA Releases REMS (RPM Report) ($)
  • FDA: From Risk Aversion to Approval Activism (PharmExec)
  • CTTI's ABDD-QbD pilot study team tackles important clinical trial design issues (CTTI)
  • New MAPP for FDA's Office of Pharmaceutical Science Coordinating Committee (OPS CC) (FDA)
  • FDA Issues Tentative Approval for Lupin's Amlodipine; Valsartan HCl (ANDA #200797) and approval for Accord's Allopurinol (ANDA #203154) (FDA)
  • OMB Submission: Comment Request: Evaluation of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original Biologics License Applications in PDUFA (FDA) (The Pink Sheet)
  • California Regulators Warn of Possible Counterfeit HIV Drug (FDA News) ($)
  • Alcon Urges Dismissal Of Drug Bottle Size Class Action (Law 360) ($)
  • Lessons From Philips FCPA Settlement Over Polish Bribes (Law 360) ($)
  • Actelion gets go-ahead to continue new drug trial (Reuters)
  • Texas Introduces Biological Substitution Bill (Scout)
  • Rhode Island Introduces Bill to Track Controlled Substances Through an Electronic Database (Scout)
  • U.S. to contribute to 'rapid' biosimilar market growth through 2023, study finds (DSN)
  • Getting to the right relationship between doctors and drug companies (AEI)
  • Elixir Medical Announces FDA Approval to Commence EXCELLA III Clinical Trial with DESyne® Nx Novolimus Eluting Coronary Stent System in the United States (Business Wire)
Medical Devices
  • Long wait for device identifier gets longer (Modern Healthcare)
  • FDA Posts Transcript of its Meeting on the Effects of Extreme Weather on Medical Devices (FDA)
  • FDA Posts Meeting Materials from the 2-3 May 2013 Meeting on the General and Plastic Surgery Advisory Panel (FDA)
  • Medtronic Issues Class 1 Recall for Deep Brain Stimulation lead Kit and Activa Dystonia HDE Kit (FDA)
  • Class 1 Recall for Maquet's SERVO-I Ventilator Battery Module (FDA)
  • Ceramax Total Hip System With Biolox Delta Ceramic-On-Ceramic 36mm Large Femoral Head Receives FDA PMA Supplement Approval (MNT) (FDA)
  • Covidien Notification of Stolen Product - Single Lot of Non-Sterile Endo GIA ArticulatingTM 60 3.5mm Single Use Loading Unit (Covidien) (FDA)
  • FDA Considering Reclassification of Influenza Detection Devices, Currently Class I Medical Devices (FDA)
  • Life Spine Announces FDA Clearance of IRIS Anterior Cervical Plate (ACP) System (Business Wire)
  • Corgenix Gains CE Mark for ReLASV Antigen Rapid Test for Diagnosis of Lassa Fever (Business Wire)
  • X-spine Announces FDA Clearance of New Spinal Implant System (Business Wire)
  • FDA Approves Biotronik Device (Cardiovascular Business) (Business Wire)
  • FDA-approved device detects diabetic neuropathy via sweatglands (Fierce Health IT)
  • Hamburg: Sequestration will compromise ability for FDA to do its job (Reuters)
  • Fatal flaws of trial designs: Nissen explains and blasts GSK RECORD trial (SCRIP Intelligence) ($)
  • PCORI awards second round of research projects (BioCentury) (PCORI)
  • OMB Approves FDA Collection Entitled " Public Health Service Guideline on Infectious Disease Issues on Xenotransplantation" (FDA)
  • David Freeman: Debarment Order (FDA)
  • CTTI Gets Some New Board Members, Including Some from PCORI, TransCelerate Biopharma, Medtronic and CMS (CTTI)
  • Proactive Planning for HHS-OIG-DOJ Investigations (Policy and Medicine)
  • WLF to Host Webinar on Implications of Sunshine Act (CHC) (Policy and Medicine)
  • Drug Marketing Blamed for Increase in ADHD Diagnoses (Medpage Today)
  • Office of Health Assessment and Translation Evaluation of the State of the Science for Transgenerational Inheritance of Health Effects; Request for Information (NIH)
  • Hospital Prices No Longer Secret As New Data Reveals Bewildering System, Staggering Cost Differences (Huffington Post) (Washington Post) (NYTimes) (Washington Post)
  • FDA/ISPE Workshop: Redefining the `C' in CGMP: Creating, Implementing, and Sustaining a Culture of Quality (FDA)
  • Emanuel: Reconsidering the Declaration of Helsinki (The Lancet)
  • Sexual Supplements Voluntarily Withdrawn From Market (Natural Products Insider) (FDA) (FDA) (FDA) (FDA) (FDA) (FDA) (FDA)
  • Foreign Food Inspections on Decline as Illnesses From Imported Goods Rise (NYTimes)
Government and Budget
Warning Letters
  • (Medical Device) Care Diagnostica GmbH for CAPA, Failure to Respond to 483 in required time, QSR, Unspecified Equipment Requirements, Failure to Validate Changes (FDA)
  • (Medical Devices) GRI Medical & Electronic Technology Co for CAPA, QSR, Product Control, Process Monitoring, OoS Equipment, Labling and Packaging Deficiencies, Quality Audits, DHR (FDA)
  • (Medical Device) Natus Europe GmbH for misbranded devices, extensive MDR problems, calibration, non-conforming products, unctonrolled labeling activities, lack of executive accountability (FDA)
  • (Pharmaceuticals) CMI Cosmetic Manufacturers for Significant CGMP Violations, lack of raw material controls, failure to follow procedure, failure to register during 2011 and 2012 (FDA)
  • (Pharmaceuticals) EuroPharma Co for marketing unapproved drugs (FDA)
  • (Dietary Supplements) ristine Bay LLC for adulterated supplements, CGMP, ADR, SOPs (FDA)
Upcoming Meetings and Events
  • 7-8 May 2013: House Hearing on Track and Trace (House)
  • 8-9 May 213: Summit on Color in Medical Imaging (FDA)
  • 8 May 2013: Vaccines and Related Biological Products Advisory Committee (FDA)
  • 8 May 2013: Intelligence Squared Debate: Is FDA's Caution Harzardous to our Health? (IQ2)
  • 9 May 2013: Senate HELP Committee Hearing on Pharmaceutical Compounding and its Proposed Legislative Solution (Senate)
  • 9 May 2013: FDA Listening Tour on Antibiotic Resistance (FDA)
  • 16 May 2013: OPDP Enfocement Actions Webinar (FDA)
  • 17 May 2013: NCATS Meeting (NCATS)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (FDA)


  • GlaxoSmithKline's 'independent experts' start to hand out keys to its data vault (Fierce Biotech) (GSK) (Pharma Times) (PMLive) (Pharmalot)
  • Dagmar Roth-Behrendt reaches for higher goals, won't from from Re-Election as MEP (Clinica)
  • Canadian Health Officials Hushed Drug Research on Safety of Antipsychotics, Suit Says (Law 360) ($) (Pharmalot)
  • European Medicines Agency closed 9-10 May 2013 (EMA)
  • Philippines Embraces Harmonized Postmarketing Alert System (FDA News) ($)
  • Industry now has marginally longer to lobby on Liese and Roth-Behrent's texts (Clinica)
  • Review sets benchmark for short-term toxicity studies (Pharma Times) (NC3R)
  • Ayush Dept plans to act tough on misleading advertisements of drugs (PharmaBiz)
  • Recall: Aurum Adrenaline 10 mL 1:10,000 pre-filled syringes (TGA)

General Regulatory and Interesting Articles

  • Surveys reveal opportunity for medical community to fully embrace biomarker testing in lung cancer (The Pharma Letter) ($)
  • France reports first case of new SARS-like virus (Reuters)
  • Injectable Oxygen Could Help People Breath Underwater; Keep Patients Alive After Lung Failure (Medical Daily)

Regulatory Reconnaissance #62 - 8 May 2013

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 and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at

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