Regulatory Focus™ > News Articles > Regulatory Recon: Huge Win for FDA in Apotex Import Ban Case (27 August 2014)

Regulatory Recon: Huge Win for FDA in Apotex Import Ban Case (27 August 2014)

Posted 27 August 2014 | By Alexander Gaffney, RAC

Regulatory Recon: Huge Win for FDA in Apotex Import Ban Case (27 August 2014)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

This fall, regulatory professionals from across the globe will come together to learn, connect and share at the Regulatory Affairs Professionals Society’s 2014 RAPS: The Regulatory Convergence, 27 September-1 October, Austin, TX.  Register by 29 August 2014 to receive the lowest rate.

In Focus: US

  • Arbitration tribunal backs FDA in NAFTA dispute with generic drug firm Apotex ( Canadian Press) ( Law 360-$)
  • Critics Slam FDA Plan to Up Minorities in Studies ( MedPage Today) ( FDA)
  • Who can Recall what FDA’s Mandatory Recall Authority is? A U.S. District Court Could Not… ( FDA Law Blog)
  • Eliminating the Disparity in 2253 Filing Requirements ( RegulatoryRx)
  • PhRMA wants payment system clarity from CMS ( BioCentury) ( Pharmalot) ( IHP-$)
  • Guidance On Nucleic Acid-Based IVDs Recommends Analytical, Clinical Studies ( Gray Sheet-$)
  • St. Jude Medical Resolves FDA Warning Letter for Plano Facility ( Press)

In Focus: International

  • Generic Drug Makers Tussle With International Standards Group ( Pharmalot) ( IHP-$)
  • NICE confirms recommendation for Biogen MS pill Tecfidera ( Pharma Times) ( PMLive)
  • European Commission Approves Bristol-Myers Squibb’s Hep C Drug Daklinza ( Press)
  • EU Commission starts to ponder effectiveness of its medical device working groups ( Clinica-$)
  • India committee on clinical trials gives clearance to only 9 new trial proposals ( PharmaBiz)

US: Pharmaceuticals and Biotechnology

  • Arbitration tribunal backs FDA in NAFTA dispute with generic drug firm Apotex ( Canadian Press) ( Law 360-$)
  • Critics Slam FDA Plan to Up Minorities in Studies ( MedPage Today) ( FDA)
  • Who can Recall what FDA’s Mandatory Recall Authority is? A U.S. District Court Could Not… ( FDA Law Blog)
  • Eliminating the Disparity in 2253 Filing Requirements ( RegulatoryRx)
  • Biomedical Reform Legislation May Be Piecemeal But Holistic ( Pink Sheet-$)
  • Ambien Linked To Doubling of Emergency Department Visits ( Forbes)
  • GSK's Promacta OK’d in severe aplastic anemia ( SCRIP-$) ( BioCentury) ( Pharma Times) ( Medscape) ( Press)
  • PhRMA Urges Court to Reject Off-Label Promotion Case ( MM&M) ( Fierce) ( Law 360-$)
  • Generic Cos. Back On Hook In Reglan Failure-To-Warn Case ( Law 360-$)
  • Teva recalls Parkinson's disease drug because it may be 'superpotent' ( Fierce)
  • Fresenius Kabi Receives FDA approval for Kabiven and Perikabiven ( Press)

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

  • FDA Grants Amgen Priority Review Designation For Ivabradine For The Treatment Of Chronic Heart Failure ( Press)

US: Pharmaceuticals and Biotechnology: General

  • PhRMA wants payment system clarity from CMS ( BioCentury) ( Pharmalot) ( IHP-$)
  • Interagency Task Force on Antimicrobial Resistance (ITFAR) Public Meeting Cancellation ( CDC)
  • Teva, AstraZeneca Say Court Rulings Kill Nexium Delay Suit ( Law 360-$)

US: Medical Devices

  • Telecom Industry Supports FDA Guidance on Medical Device Data Systems ( Health Data Management)
  • Boston Sci gets bad news on four of 23,000+ vaginal mesh lawsuits ( Fierce)
  • Guidance On Nucleic Acid-Based IVDs Recommends Analytical, Clinical Studies ( Gray Sheet-$)
  • St. Jude Medical Resolves FDA Warning Letter for Plano Facility ( Press)
  • Morcellator Manufacturer Karl Storz Taking Hard Line on Defending Rotocut Device ( Dropbox)
  • FDA Clears Westmed’s Vibralung Acoustical Percussor For CF, Other Respiratory Diseases ( CF News Today)
  • DePuy's Craniomacillofacial Distraction System Recalled ( FDA)
  • Recall of Sterile Convenience Surgical Packs by Customed, Inc ( FDA)
  • Current FDA's Warning Letters on IT Topics - Part 1: Medical Devices ( GMP Compliance)

US: Dietary Supplements

  • Drug Claims For Supplements Put Enforcement Bulls Eye On Firms ( Tan Sheet-$)
  • Improving Documentation of GMP Procedures ( NPI)

US: Assorted And Government

  • OpenFDA Hopes to Provide Model Government API Strategy ( Programmable Web)
  • WANTED: Consumers to Report Problems ( FDA)

Ebola Outbreak

  • How Will We Know If The Ebola Drugs Worked? ( Forbes)
  • British Ebola patient Will Pooley taking experimental drug ZMapp ( Guardian)

Europe

  • NICE confirms recommendation for Biogen MS pill Tecfidera ( Pharma Times) ( PMLive)
  • European Commission Approves Bristol-Myers Squibb’s Daklinza (daclatasvir) Across Multiple Genotypes for the Treatment of Chronic Hepatitis C Infection ( Press)
  • EU Commission starts to ponder effectiveness of its medical device working groups ( Clinica-$)
  • EU okays Vifor Fresenius phosphate binder Velphoro ( Pharma Times)
  • Yes and No: Leaders clash over NHS as Scottish referendum nears ( SCRIP-$)
  • European Medicines Agency publishes booklet on European regulatory system for medicines ( EMA)

India

  • Apex committee on clinical trials gives clearance to only 9 new trial proposals ( PharmaBiz)
  • DCGI sets up ICC within CDSCO to address issues of exporters ( PharmaBiz)

Japan

  • Japan's IPR text red-flagged ahead of regional FTA meet ( SCRIP-$)

Other International

  • Generic Drug Makers Tussle With International Standards Group ( Pharmalot) ( IHP-$)
  • Korea: First approval for Green Cross' Neulasta rival ( SCRIP-$)
  • Nigeria's Chief Regulator Akunyili Remembered ( Sun News)

Clinical Trials

  • New report shows that HPV vaccine trials can be significantly shortened ( MNT)
  • Volunteer drug users: the highs and lows of addiction trials ( Outsourcing Pharma)

General Regulatory And Interesting Articles

  • 1 Key Tip to Nailing your Regulatory Affairs Interview ( Regdy)
  • Are Expired Medications OK to Take? ( WSJ-$)

Regulatory Reconnaissance #387 – 27 August 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.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


Categories: Recon, Regulatory News

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