Regulatory Focus™ > News Articles > Regulatory Recon: FDA Wants More Data on Hand Sanitizers Used in Hospitals (30 April 2015)

Regulatory Recon: FDA Wants More Data on Hand Sanitizers Used in Hospitals (30 April 2015)

Posted 30 April 2015 | By Alexander Gaffney, RAC

Regulatory Recon: FDA Wants More Data on Hand Sanitizers Used in Hospitals (30 April 2015)

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

In Focus: US

In Focus: International

  • EMA publishes 2014 annual report on progress in science, medicines and Health (EMA)
  • European Court of Justice Justifies Some Bans on Donated Blood (FT-$) (CBC)
  • Indian Commerce ministry assures industry on track & trace system (PharmaBiz)
  • What Meals? Pharma Will not Disclose all Payments to Docs Down Under (Pharmalot)
  • Regulators: skip clinical data and extrapolate biosimilar indications (BioPharma-Reporter)

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US: Pharmaceuticals and Biotechnology

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

  • U.S. Food and Drug Administration Accepts Supplemental Biologics License Application for Opdivo (nivolumab) in Patients with Previously Untreated Advanced Melanoma (Press)

US: Pharmaceuticals and Biotechnology: General

  • Express Scripts says controlling cancer-drug costs a tough new focus (Reuters)

US: Medical Devices

  • FDA Looks to Downclassify Some PMA Devices (MDDI) (Gray Sheet-$) (FDA)
  • MDUFA III on Trial: FDA and Device Reviews (Thompson Reuters)
  • CDRH Can’t Rely On ‘Network of Experts’ Due To Confidentiality Concerns (Gray Sheet-$)
  • No Benefit For retrievable inferior vena cava filters (Forbes)
  • Medical Device Hacking—Why Are Patients Innovating and Companies Failing to Deliver? (MDDI)
  • First FDA Cleared Ophthalmic App For Monitoring AMD And DR (Press)

US: Assorted And Government

  • FDA's Weekly Enforcement Report (FDA)

Upcoming Meetings and Events

Europe

  • EMA publishes 2014 annual report on progress in science, medicines and Health (EMA)
  • Draft concept paper on the need to revise the "Guideline on the evaluation of anticancer medicinal products in man" in order to provide guidance on the reporting of safety data from clinical trials (EMA)
  • Conclusion of EDQM's Prospective Harmonisation Pilot project announced (EDQM)
  • European Court of Justice Justifies Some Bans on Donated Blood (FT-$) (CBC)
  • Arno Therapeutics Receives European Orphan Drug Designation for AR-12 to Treat Two Infectious Diseases (Press)

India

  • Commerce ministry assures to review track & trace system on issues raised by industry (PharmaBiz)
  • Higher wages in India eating quickly into low-cost generic manufacturing model (Fierce)

Australia

  • What Meals? Pharma Will not Disclose all Payments to Docs Down Under (Pharmalot)
  • Australia to include modern HTA/clinical evaluation methods in updated PBAC guidelines (SCRIP-$)
  • Australian conformity assessment changes impact high-tech devices, and recertification (SCRIP RA-$)

Other International

  • Regulators: skip clinical data and extrapolate biosimilar indications (BioPharma-Reporter)

General Regulatory And Interesting Articles

  • 3 boys saved by customized airway tube made on 3-D printer (AP) (Reuters)
  • Why Tattoos Might Be a Huge Problem for the Apple Watch (TIME)

Regulatory Reconnaissance #547 – 30 April 2015

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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