Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Veterinary Companies to Phase Out Growth-Promoting Antibiotics (11 March

Regulatory Reconnaissance: Veterinary Companies to Phase Out Growth-Promoting Antibiotics (11 March 2014)

Posted 11 March 2014 | By Alexander Gaffney, RAC

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In Focus: US

In Focus: International

  • EU Parliament delays vote, but no hope of early first reading agreement on medtech regs (Clinica-$)
  • UK to launch early access to drugs plan (Pharma Times)
  • EU Releases Reports on Reference Pricing of Medical Products (EC) (EC)
  • EMA Looks At Avastin, As Novartis/Roche Appeal Italian Competition Fines (Pink Sheet-$)
  • Health Canada Releases Five Guidance Docs, 3 Monographs (Health Canada)
  • Bill Would Give Drug Recall Power to Health Canada (MNT)

US: Pharmaceuticals/Biotechnology

  • Animal Drug Companies Formally Agree To Phase Out Growth Promotion Antibiotics (IHP-$)
  • FDA Opioid Rulings Slammed as Inconsistent (Medpage Today)
  • Teva Can't Dodge GSK's Wellbutrin False Ad Suit (Law 360-$)
  • Following FDA Guidance: Continuous Improvement in an Outsourced Environment (PCM)
  • Drug Labeling Games - Skinny Labels Getting an FDA Assist (PCM)
  • Ranbaxy scrambles for ingredients to make generic Nexium (Reuters)
  • CPR Submits Comments on the FDA Proposed Generics Labeling Rule (CPR)
  • India's Sun Pharma Recalls Diabetes Drug From U.S. After Seizure Drug Found In Bottle (PharmAsia-$)
  • Drug Company Chimerix Denies Dying Boy Experimental Medicine (CNN)

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

  • FDA accepts Lundbeck NDA for IV carbamazepine (Pharma Letter-$) (Press)
  • La Jolla Pharma's drug improves kidney function in trial, shares soar (Reuters)
  • Trophos to file olesoxime after positive data in orphan indication (SCRIP-$) (BioCentury)
  • Nexavar flunks PhIII adjuvant liver cancer trial (SCRIP-$) (Reuters)

US: Pharmaceuticals and Biotechnology: General

US: Medical Devices

  • FDA informatics chief: NGS is an immediate priority for the agency (Fierce)
  • Don't Expect Much from CDRH's New Quality Program (MDDI)
  • Court denies Myriad Genetics' motion to block rival (Reuters) (NYTimes)
  • FDA Posts Lists of New PMA Approvals (FDA) (FDA)
  • Weight-loss: FDA bumps EnteroMedics' advisory meeting for VBLOC neurostimulation system (Mass Device)
  • Wright Medical Group, Inc. Announces Agreement with FDA Office of Device Evaluation to File PMA Amendment for Augment Bone Graft In Lieu of Dispute Resolution Panel (Press)

US: Dietary Supplements

  • Medical Foods No "Dumping Ground" For Disease Claims - FDA (Tan Sheet-$)
  • Judge Denies Request To Dismiss Monster Energy Lawsuit (Food Product Design)

US: Assorted And Government

  • Hamburg to testify at Senate HELP hearing (BioCentury)
  • CDC Plans to Map DNA of Disease-Causing Viruses (Roll Call)

Europe

  • EU Parliament delays vote, but no hope of early first reading agreement on medtech regs (Clinica-$)
  • UK to launch early access to drugs plan (Pharma Times)
  • EU Releases Reports on Reference Pricing of Medical Products (EC) (EC)
  • EMA Looks At Avastin, As Novartis/Roche Appeal Italian Competition Fines (Pink Sheet-$)
  • Keryx Biopharma files for EU approval of Zerenex (Pharma Letter-$) (BioCentury)
  • UK begins assessment of Proteus Digital Health's intelligent medicine platform (MobiHealthNews) (Pharmafile) (Pink Sheet-$)
  • Sanofi MS pill Aubagio approved in Scotland (Pharma Times)
  • Torii reports Japanese data for dust mite immunotherapy (BioCentury)
  • New MHRA Guidance on Borderline Medical Devices (Inside Medical Devices)

India

  • Indian Business Hits Back At Calls For Tougher U.S. Stance Over Alleged Patent Abuses (PharmAsia-$)

Other International

  • Health Canada Releases Five Guidance Docs, 3 Monographs (Health Canada)
  • Bill C-17 gives drug recall power to Health Canada, but more needs to be done (MNT)
  • Pharma firms pressed to tackle neglected diseases in developing world (EurActiv)
  • IPQ Monthly Update, February 2014 (IPQ)

General Regulatory And Interesting Articles

  • Black Market For Organs Reportedly Alive And Well On Facebook (Huffington Post)

Regulatory Reconnaissance #273 - 11 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.

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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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