Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Judge: Regulatory Non-Compliance is Not a False Claim (25 February 2014)

Regulatory Reconnaissance: Judge: Regulatory Non-Compliance is Not a False Claim (25 February 2014)

Posted 25 February 2014 | By Alexander Gaffney, RAC

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In Focus: US

  • We'll Say It Again: Regulatory Noncompliance Does Not an FCA Case Make (FDA Law Blog)
  • "Grades" for FDA Approvals: When Academics Weigh in on Regulation (RPM Report-$)
  • FDA approves Myalept to treat rare metabolic disease (FDA)
  • FDA Blames Over-Reporting For Record-High Recall Count In 2013; Looks To Root Causes (Silver Sheet-$)
  • Health data industry fights FDA oversight (Boston Globe)
  • Ball In Judge's Court In Combination Product Classification Suit (Gray Sheet-$)

In Focus: International

  • EMA backs model from Novartis to identify safest, most effective Phase III dose (BioCentury-$)
  • Guidelines and concept papers Adopted during the CHMP meeting 17-20 February 2014 (EMA)
  • NICE turns down BMS's Yervoy for first-line use (SCRIP-$) (Pharma Letter-$) (PharmaTimes)
  • EU bolsters power to tackle in-transit counterfeits (Securing Industry)
  • Ranbaxy Laboratories suspends drug ingredients shipment from 2 plants (India Times) (Pharma Letter-$) (In-Pharma)
  • Indian Drug Regulator Denies Press Reports That he Won't Hold Indian Companies to Higher Standards (CDSCO)

US: Pharmaceuticals/Biotechnology

  • We'll Say It Again: Regulatory Noncompliance Does Not an FCA Case Make (FDA Law Blog)
  • FDA mulling in vitro fertilization with embryos made from 3 parents (CBS) (SciAm)
  • "Grades" for FDA Approvals: When Academics Weigh in on Regulation (RPM Report-$)
  • US FDA's Hamburg offers few details on trip to India (In-Pharma)
  • Ultragenyx's Kakkis lists innovations that could spur Orphan drug development (BioCentury-$)
  • BioCentury on the History and Successes of the Orphan Drug Act (BioCenturyTV)
  • Some Indian Generic Drug Companies Are Selling Shoddy, Ineffective, FDA-Approved Medicines To U.S. Patients (Forbes)
  • FDA approves Myalept to treat rare metabolic disease (FDA)
  • Pfizer Announces FDA Approval of XELJANZ  (tofacitinib citrate) (Press)
  • Iroko Pharmaceuticals Receives FDA Approval for TIVORBEX (Press)
  • Recall of BIVIGAM Immune Globulin Intravenous Due to Vial Integrity Defects (CBER)
  • New MAPP on CDER FTEs (FDA)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

  • InterMune Hits Home Run With Pivotal Lung Drug Study Results (The Street) (Fierce)
  • rEVO Biologics Announces the Submission of an IND for ATryn in Preeclampsia (Press)
  • Regeneron's Eylea under FDA review for macular edema after BRVO (SCRIP-$) (Press)
  • B-MS oral HCV combo gets FDA breakthrough status (Pharma Times) (SCRIP-$) (PMLive) (Fierce) (Press)
  • FDA considers expanded use of Xiaflex in Dupuytren's contracture (SCRIP-$)

US: Pharmaceuticals and Biotechnology: General

  • How The Black Market Distributes Counterfeit Drugs In The U.S. (SafeMedicines)

US: Medical Devices

  • FDA Blames Over-Reporting For Record-High Recall Count In 2013; Looks To Root Causes (Silver Sheet-$)
  • Health data industry fights FDA oversight (Boston Globe)
  • Ball In Judge's Court In Combination Product Classification Suit (Gray Sheet-$)
  • Who's to blame when a device goes rogue? (mHealthNews)
  • 10 Most Frequently Recalled Device Types (Silver Sheet-$)
  • Device Center Recall Chief Talks Health Hazard Evaluations (Silver Sheet-$)
  • Biosense Webster Receives FDA Approval for First Catheter Ablation Therapy in the U.S. to Feature Direct Contact Force Technology for Treatment of Atrial Fibrillation (Press)
  • Samsung adds heart rate sensor to its newest smartwatches (MobiHealthNews)
  • FDA Warns of Class 1 Recalls for Teleflex, Medline Devices

US: Dietary Supplements

  • Vitamin Supplements Come Up Short Once Again (Forbes)

US: Assorted And Government

  • FDA/NIH advocate, House 'Dean' John Dingell to depart Congress (SCRIP-$) (BioCentury)
  • Obama's rush to regulate (The Hill)
  • The Underlying Condition: Increasing Diversity in Clinical Trials (National Journal)
  • The Regulatory Accountability Act: Or How to Defeat the Public Interest in Just 65 Easy Steps (CPR)

Upcoming Meetings And Events

  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • EMA backs model from Novartis to identify safest, most effective Phase III dose (BioCentury-$)
  • Guidelines and concept papers Adopted during the CHMP meeting 17-20 February 2014 (EMA)
  • NICE turns down BMS's Yervoy for first-line use (SCRIP-$) (Pharma Letter-$) (PharmaTimes)
  • EU bolsters power to tackle in-transit counterfeits (Securing Industry)
  • NICE backs Invokana for Type II diabetes (BioCentury)
  • Global Quality Regulatory Maze Jeopardizes Vaccine Supply, IFPMA is Stressing (IPQ-$)
  • Endocyte Anticipating Positive CHMP Opinion On Ovarian Cancer Drug/Diagnostic Combo (Pink Sheet-$)
  • EC approves Piramal's NeuraCeq imaging agent (BioCentury)

India

  • Ranbaxy Laboratories suspends drug ingredients shipment from 2 plants (India Times) (Pharma Letter-$) (In-Pharma)
  • Indian Drug Regulator Denies Press Reports That he Won't Hold Indian Companies to Higher Standards (CDSCO)
  • Ranbaxy Overhauls Plants to Improve Drug Quality and Beat US ban (Financial Times)
  • India Mulls Taking U.S. IP Priority List To WTO Complaint Process (PharmAsia-$)

Japan & China

  • Novartis gets fourth indication, DME, for Lucentis in Japan (Pharma Letter-$)

Other International

  • International Panel of Regulators Spotlights Current Biotech CMC Regulatory Problems and Convergence Pathways (IPQ-$)
  • Taiwan FDA Drops Antibody Type Over Risks Of Severe Side Effects (PharmAsia-$)

General Regulatory And Interesting Articles

  • Polio-Like Illness Sickens Kids in California (NBC) (SciAm)
  • Acetaminophen use during pregnancy linked to ADHD in children (CBS) (Forbes)
  • Data mining study links seasonal flu vaccine to 24% drop in likelihood of stroke (Fierce)

Regulatory Reconnaissance #263 - 25 February 2014

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 news@raps.org.


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