Regulatory Focus™ > News Articles > Regulatory Recon: FDA's Updates NDA Notification Policy (26 August 2014)

Regulatory Recon: FDA's Updates NDA Notification Policy (26 August 2014)

Posted 26 August 2014 | By Alexander Gaffney, RAC

Regulatory Recon: FDA's Updates NDA Notification Policy (26 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

  • FDA’s NDA Review Notification Policy Gets Update At User Fee Program’s Midpoint (Pink Sheet-$) (FDA)
  • FDA Recall Powers Should Be Limited, FDA Says (Pink Sheet-$)
  • 'Black box' warning on antidepressants vastly reduced lawsuits against Eli Lilly, others (IndyStar)
  • Alkermes seeks FDA approval for injectable treatment for schizophrenia symptoms (MedCity News) (SCRIP-$) (BioFlash) (BioCentury) (Boston Globe)
  • FDA Reclassifies Hemoglobin A1c Test Systems as Class II With Special Controls (FDA) (Gray Sheet-$)
  • FDA takes action against Georgia dietary supplement manufacturer (FDA)

In Focus: International

  • DCGI renames new drug advisory committees as subject expert committees (PharmaBiz)
  • Mad at NICE's cancer drug rejections? Look to drugmakers, agency chief says (Fierce)
  • Easier access to medicines in the UK? (PMLive) (Pharmafile)
  • America's "Great Generic Wars" and the Canadian-European Trade Agreement (PharmExec)

US: Pharmaceuticals and Biotechnology

  • FDA’s NDA Review Notification Policy Gets Update At User Fee Program’s Midpoint (Pink Sheet-$) (FDA)
  • FDA Recall Powers Should Be Limited, FDA Says (Pink Sheet-$)
  • 'Black box' warning on antidepressants vastly reduced lawsuits against Eli Lilly, others (IndyStar)
  • Iroko's Zorvolex gets second FDA approval for osteoarthritis NSAID (BizJournal)

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

US: Pharmaceuticals and Biotechnology: General

US: Medical Devices

  • Medtronic snags FDA approval for next-generation pacemaker (Fierce)
  • FDA Reclassifies Hemoglobin A1c Test Systems as Class II With Special Controls (FDA) (Gray Sheet-$)
  • Upcoming Medical Device Webinars and Stakeholder Calls (FDA)
  • Customed, Inc. Issues Recall of Sterile Convenience Surgical Packs (FDA)

US: Dietary Supplements

  • FDA takes action against Georgia dietary supplement manufacturer (FDA)
  • Can a Dietary Supplement Treat a Concussion? No! (FDA)
  • “Mender” Supplement Firm Hopes To Reopen After Mending Its Violations (Tan Sheet-$)

US: Assorted And Government

  • House Committee Chairman Doesn't Expect Path2Cures Legislation Before 2015 (Twitter)

Ebola Outbreak

  • Canada’s Immunovaccine says animal test of Ebola vaccine promising (MedCity News)

Europe

  • Mad at NICE's cancer drug rejections? Look to drugmakers, agency chief says (Fierce)
  • Easier access to medicines in the UK? (PMLive) (Pharmafile)
  • MHRA launches stroke drug review (OnMedica)

India

  • DCGI renames new drug advisory committees as subject expert committees (PharmaBiz)

Japan

  • Janssen Files For Japan Approval Of Triple Ingredient HIV Drug (PharmAsia-$)

Canada

  • America's "Great Generic Wars" and the Canadian-European Trade Agreement (PharmExec)
  • Health Canada Approves Eloctate(TM), the First Therapy to Extend the Interval Between Prophylactic Infusions in Hemophilia A (Press)

Clinical Trials

  • Drug Supply Shortages in Clinical Trials, Part 3 (BioClinica)
  • A regulatory perspective on essential considerations in design and analysis of subgroups when correctly classified (PubMed)
  • Alternative medicine studies criticised by researchers (PMLive)

General Regulatory And Interesting Articles

  • AIDS Progress in South Africa Is in Peril (NYTimes)

Regulatory Reconnaissance #386 – 26 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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