Regulatory Focus™ > News Articles > Regulatory Reconnaissance: State Ban on Zohydro Likely to be Struck Down (9 April 2014)

Regulatory Reconnaissance: State Ban on Zohydro Likely to be Struck Down (9 April 2014)

Posted 09 April 2014 | By Alexander Gaffney, RAC

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org.

In Focus: US

  • Judge indicates she'll strike down Massachusetts Zohydro ban (Boston Globe) (Boston Herald) (FDA Law Blog)
  • How Often Does FDA Follow the Advice of its Advisory Committees? (Twitter)
  • GPhA, EGA Weigh in on TTIP's Regulatory Provisions, Seek Regulatory Harmonization (GPhA)
  • FDA halts Halozyme's pancreatic cancer study (Reuters)
  • FDA Stops Issuing NHRIC, NDC labeler codes to device manufacturers (FDA)
  • Ex-CDRH Engineer Petitions to Widen Use of Product Codes (MDDI)
  • Analysis: The Significance and Insignificance of the FDASIA HIT Report (MobiHealthNews)

In Focus: International

  • French wrestle with major concerns over biosimilar substitution (SCRIP-$)
  • Regulatory uncertainties hampering European advanced therapy sector, report (BioPharma Reporter)
  • Good news trickles in for Ranbaxy, FDA approves Gurgaon & Romania R&D centres (India Times)
  • Exports to Europe from Ranbaxy's two plants to remain suspended (India Times)
  • WHO publishes revised draft on the Guideline on "Hold Time" studies (ECA)

US: Pharmaceuticals/Biotechnology

  • Judge indicates she'll strike down Massachusetts Zohydro ban (Boston Globe) (Boston Herald) (FDA Law Blog)
  • How Often Does FDA Follow the Advice of its Advisory Committees? (Twitter)
  • GPhA, EGA Weigh in on TTIP's Regulatory Provisions, Seek Regulatory Harmonization (GPhA)
  • FDA halts Halozyme's pancreatic cancer study (Reuters)
  • FDA: Value Of A Qualified Clinical Outcome Measure (FDA-PDF)
  • Warning Letter for Medicated Feed Manufacturer (FDA)
  • Expedited Reviews and the Current State of Drug Development (Context Matters)
  • Teva launches first generic of GSK's Lovaza in US (PMLive) (SCRIP-$) (AP)
  • Sarepta Therapeutics on Cusp of Huge Eteplirsen News (The Street)

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

  • CMC Setback for Forest, Almirall's Aclidinium and Formoterol FDC (Press)
  • Pharmacyclics submits sNDA toward full Imbruvica approval in CLL (SCRIP-$)

US: Pharmaceuticals and Biotechnology: General

US: Medical Devices

  • FDA Stops Issuing National Health Related Items Code (NHRIC) and National Drug Code (NDC) labeler codes to device manufacturers (FDA)
  • Ex-CDRH Engineer Petitions to Widen Use of Product Codes (MDDI)
  • Analysis: The Significance and Insignificance of the FDASIA HIT Report (MobiHealthNews)
  • FDA Ignored Device Reclassification Process, DC Circ. Told (Law 360-$)
  • Boston Scientific lands U.S., E.U. nods for Expect Slimline needle (Mass Device)
  • Medtronic's Drug-Coated Balloon Impresses In Peripheral Artery Trial (Gray Sheet-$)
  • GE Healthcare Receives FDA Clearance For Q.Clear Technology (Press)
  • January 2014 PMA Approvals (FDA)

US: Dietary Supplements

  • FDA Warning Letter: Beverage Products Misrepresented as Dietary Supplements (NPI)

US: Assorted And Government

  • BIO Calls on Appropriators to Fully Fund FDA (BIO)

Europe

  • French wrestle with major concerns over biosimilar substitution (SCRIP-$)
  • Regulatory uncertainties hampering European advanced therapy sector, report (BioPharma Reporter)
  • Sanofi Pasteur MSD's Gardasil approved in the European Union for a 2-dose schedule in children aged from 9 to 13 years (Press)
  • Abiomed wins CE Mark for Impella RP heart pump (Mass Device)

India

  • Good news trickles in for Ranbaxy, FDA approves Gurgaon & Romania R&D centres (India Times)
  • Exports to Europe from Ranbaxy's two plants to remain suspended (India Times)
  • Gilead aims to license hepatitis C drug to 3-4 Indian firms (Reuters)

Other International

  • WHO publishes revised draft on the Guideline on "Hold Time" studies (ECA)
  • WHO issues its first hepatitis C treatment guidelines (WHO)
  • WHO joins clamor to make new hepatitis C pills affordable (Reuters)
  • CAN/CSA C22.2 No. 60601-1:14 (Harmonized with Ed. 3.1) Recently Released (Eisner)
  • Analytical Methods - USP's Future Expectations (ECA)

General Regulatory And Interesting Articles

  • Study Suggests Link Between Viagra And Melanoma (Forbes)
  • Low-dose aspirin may prevent preeclampsia: panel (Reuters)
  • China's WuXi invests in edible anti-counterfeiting tech (Fierce)
  • The Use of Preliminary Scientific Evidence in Public Health: A Case Study of XMRV (PLoS)

Regulatory Reconnaissance #294 - 9 April 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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