Regulatory Focus™ > News Articles > Regulatory Reconnaissance: 25 Companies Commit to FDA Antibiotic Limits (27 March 2014)

Regulatory Reconnaissance: 25 Companies Commit to FDA Antibiotic Limits (27 March 2014)

Posted 27 March 2014 | By Alexander Gaffney, RAC

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In Focus: US

  • F.D.A. Unveils Deal to Limit Antibiotic Use in Animal Feed (FDA) (NYTimes) (WSJ-$) (AP) (NBC)
  • New FDA Breakthrough-Drug Category - Implications for Patients (NEJM) (Pink Sheet-$)
  • OTC Monograph System In "Slow Death Spiral" From FDA's Neglect - Hutt (Tan Sheet-$)
  • FDA panel split on Epigenomics' Epi ProColon (MedPage Today) (BioCentury)
  • J&J May Have Destroyed Vaginal Mesh Docs, DOJ Told (Law 360-$) (Fierce) (AP)
  • Baxter Announces Plans to Split Into Two Separate Healthcare Companies (Press) (NYTimes)

In Focus: International

US: Pharmaceuticals/Biotechnology

  • F.D.A. Unveils Deal to Limit Antibiotic Use in Animal Feed (FDA) (NYTimes) (WSJ-$) (AP) (NBC)
  • New FDA Breakthrough-Drug Category - Implications for Patients (NEJM) (Pink Sheet-$)
  • OTC Monograph System In "Slow Death Spiral" From FDA's Neglect - Hutt (Tan Sheet-$)
  • Shortage Within A Shortage: Baxter Adjusts Allocation Of I.V. Products As Shortage Drives Demand (Pink Sheet-$) (Fierce)
  • Drug Shortage Optimism: FDA, Industry Expect Faster Resolution Than GPhA (Pink Sheet-$)
  • Karen Midthun Again Defends Agency Action on Bexsero MenB Vaccine (Roll Call)
  • More Disclosure Coming in Merck's Decade-Long Vioxx Nightmare (WSJ)
  • FDA, Sponsors Seek Study Endpoints Earlier in Development (PharmExec)
  • Attorneys general seek to pull 'powerful' painkiller  Zohydro (USA Today)
  • Under Fire, Zohydro Maker Touts Drug Safety Board (AP)
  • NYTimes Editorial Board Comes out in Support of FDA's Generic Drug Labeling Rule (NYTimes)
  • Pfizer Initiates Recall for 70k Bottles of Subpotent Advil PM Capsules (FDA)
  • High Court Changed Hatch-Waxman Cases - Nobody Noticed (Law 360-$)
  • Better Medicine: Overcoming 20th-century regulations to allow 21st-century cures (Reason)
  • FDA Approves Wider Dose Range for Genzyme's Thyrogen (Press)
  • Indiana biosimilar bill becomes law (BioCentury) (BioPharma Reporter)
  • Husband Seeks Compassionate Use Of Anti-PD-1 Drug For Young Wife With Rare Kidney Cancer (Forbes)

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

  • Avanir migraine drug-device combo under FDA review (SCRIP-$) (Press)
  • pSivida Announces Resubmission of New Drug Application for ILUVIEN (Press)
  • Novartis Rare Lung Cancer Investigational Drug Ceritinib Shows Positive Response (RTT) (WSJ-$) (Reuters)
  • Synthon announces successful outcome of the Phase III GATE study with its generic glatiramer acetate (Press)
  • Exelixis' shares flogged after lead drug disappoints at interim PhIII point (Fierce) (The Street)
  • Swedish Orphan falls on Phase III miss for Kiobrina (BioCentury)

US: Pharmaceuticals and Biotechnology: General

  • Baxter Announces Plans to Split Into Two Separate Healthcare Companies (Press) (NYTimes)
  • GSK Handed $106M Verdict For Paxil Generic Contract Breach (Law 360-$)
  • Florida man threatened to poison J&J products unless it forked over cash (Fierce)
  • Oklahoma Told It Can't Shield Suppliers of Execution Drugs (NYTimes)

US: Medical Devices

  • FDA panel split on Epigenomics' Epi ProColon (MedPage Today) (BioCentury)
  • J&J May Have Destroyed Vaginal Mesh Docs, DOJ Told (Law 360-$) (Fierce) (AP)
  • Does An ONC Tweet Reflect Conflict With FDA Over Health IT Regulation? (Gray Sheet-$)
  • Reining in FDA regulation of mobile health apps (Washington Post)
  • Medtronic is expected to publicly detail its failed renal denervation pivotal study on March 29 (Fierce)
  • West Health Institute gets ONC, FDA support for interoperability (MobiHealthNews)
  • Guided Therapeutics Submits Request for Face to Face Meeting with FDA; Receives Notification on PMA Extension for LuViva Advanced Cervical Scan (Press)

US: Dietary Supplements

  • PharmaRoth Looks Abroad With Type 2 Diabetes Product After NDI Notification Decision (Pink Sheet-$)
  • US: Assorted And Government
  • Women Make up 59% of FDA's Workforce (FDA)

Europe

India

  • Ranbaxy's Paonta Site Clears Joint Inspection By Five Regulators (PharmAsia-$)
  • Indian Drug Regulator Held on Graft Charges (Times of India)
  • DIPP rejects proposal for cheaper versions of cancer drug Dasatinib (India Times)
  • Pfizer Gets Stay Of India Patent Withdrawal OfDetrol Incontinence Drug (PharmAsia-$)

Japan & China

  • World first: Japan OKs Otsuka's Samsca for rare kidney disease (Pharma Times) (WSJ)
  • Japan approves treprostinil for PAH (BioCentury)

General Regulatory And Interesting Articles

Regulatory Reconnaissance #285 - 27 March 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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