Regulatory Reconnaissance: FDA Failing to Protect Consumers from Faulty Generics (27 February 2014)

Posted 27 February 2014 | By Alexander Gaffney, RAC 

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In Focus: US

In Focus: International

  • Cell Thera's NHL drug Pixuvri gets backing from UK's NICE (Pharma Letter-$) (SCRIP-$) (PMLive)
  • Britain sets out plans for first 'three-parent' IVF babies (Reuters)
  • NICE Yervoy, Invokana Rulings Show Need for Regulator/HTA Dialogue (Pink Sheet-$)
  • EU Approves 2014-2020 Health Programme (EU) (EU)
  • MHRA received 286 advertising complaints in 2013 (PMLive)

US: Pharmaceuticals/Biotechnology

  • FDA Failed to Track Substandard Generics, Congress Told (Bloomberg) (India Times) (In-Pharma)
  • FDA, EMA Regulators Say Incretin-Based Diabetes Drugs Are Safe (NEJM) (Pink Sheet-$) (NYTimes) (AP)
  • New Fees Made FDA Less Effective on Generic Drug Approvals, Says GPhA Chairman (PharmExec)
  • Republicans say FDA spying may have broken whistleblower law (Law 360-$) (Washington Post) (Grassley) (BioCentury) (FDA) (POGO) (Grassley) (Report) (AP) (Reuters)
  • Senators probe 'pay-to-play' allegations on FDA approval of painkillers (The Hill)
  • With John Dingell's Departure from Congress, Maybe it is Time to Reflect on the Generic Drugs Scandal (Lachman)
  • Drug Safety In Pregnant Women: FDA Seeks Alternatives To Registries (Pink Sheet-$)
  • Not Jazzed About Xyrem REMS, Irish Company Begins Dispute Resolution (Pink Sheet-$)
  • Eliquis earns best safety score in its class in analysis of FDA adverse event reports (Fierce)
  • Panel Votes For Removing Nebulizer, Asthma Ingredients From Monograph (Tan Sheet-$)
  • FDA under pressure to review sunscreen ingredients (Cosmetics Design)
  • BioNJ Streamlines Clinical Trials Agreement Process (BIO)
  • FDA Adverse Event Reporting System (FAERS): Latest Quarterly Data Files (FDA)

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

  • Forest Laboratories Submits a New Drug Application for Nebivolol and Valsartan Combination in Hypertension (Press)
  • FDA Grants Astellas Qualified Infectious Disease Product Designation for Isavuconazole for the Treatment of Invasive Mucormycosis (Press)
  • Triphase Receives FDA Orphan Drug Designation for Marizomib in Multiple Myeloma (Press)
  • Baxter Presents Data at EAHAD from Long-Term Outcomes Registry Reinforcing Prophylaxis Treatment Experience with ADVATE (Press)

US: Pharmaceuticals and Biotechnology: General

  • Oklahoma Death Row Inmates Sue Over Drugs' Secrecy (AP)

US: Medical Devices

  • Reflecting on the First Year of CDRH's 510(k) Refuse to Accept Policy (FDA Law Blog)
  • Feds promise to publish FDASIA report on HIT regulation in March (Fierce)
  • U.S. FDA updates electronic system for medical device exporters (Emergo)
  • FDA Spotlights Devices With Antimicrobial Surface Coatings (Gray Sheet-$)
  • Study challenges FDA's stance on CT risks to implanted devices (Cardiovascular Business)
  • Carestream lands FDA nod for X-ray app on Apple, Samsung devices (Mass Device)
  • Covidien Announces U.S. Food and Drug Administration 510(k) Clearance for the Puritan Bennett 980 Ventilator (Press)

US: Dietary Supplements

US: Assorted And Government

  • FDA Press Releases - What They Say (Eye on FDA)
  • Enforcement Report - Week of February 26, 2014 (FDA)
  • NIH adding medical data to sequence database (BioCentury)

Upcoming Meetings And Events

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


  • Cell Thera's NHL drug Pixuvri gets backing from UK's NICE (Pharma Letter-$) (SCRIP-$) (PMLive)
  • NICE Yervoy, Invokana Rulings Show Need for Regulator/HTA Dialogue (Pink Sheet-$)
  • Britain sets out plans for first 'three-parent' IVF babies (Reuters)
  • Cubist Announces EMA Acceptance of Tedizolid Marketing Authorization Application for Review (Press)
  • EU Approves 2014-2020 Health Programme (EU) (EU)
  • MHRA received 286 advertising complaints in 2013 (PMLive)
  • Mitochondrial donation consultation launched (UK)

Other International

  • GSK's Witty Says he's Committed to Making Malaria Vaccine Affordable (ITV)

General Regulatory And Interesting Articles

  • Blood pressure meds may raise elderly fall risk (Reuters)

Regulatory Reconnaissance #265 - 27 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.

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