Regulatory Focus™ > News Articles > Regulatory Recon: IOM Endorses Sharing of Clinical Trials Data (15 January 2015)

Regulatory Recon: IOM Endorses Sharing of Clinical Trials Data (15 January 2015)

Posted 15 January 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: IOM Endorses Sharing of Clinical Trials Data (15 January 2015)

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

In Focus: US

In Focus: International

  • India rejects Gilead's Hepatitis C drug patent request (Reuters) (SCRIP-$) (Pharmalot) (PharmAsia-$) (PharmaTimes) (Fierce) (Bloomberg)
  • WHO guidance aims to help regulators identify 'false' biosimilars (SCRIP RA-$)
  • How well does EU notified body database NANDO stand up under harsh climes? Commission in the hot seat (Clinica-$)
  • Final opinion - Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices (SCENIHR)
  • EU Commission to part-fund authorities’ medtech market surveillance programs (Clinica-$)
  • Italian pharmacists likely to defy EU's ruling on over the counter morning-after pill (Independent)
  • Indian Device Industry urges govt to re-draft D&C Act (Amendment) Bill to meet domestic manufacturers' requirements (PharmaBiz)

US: Pharmaceuticals and Biotechnology

  • FDA Touts Success of 2014 New Drug Approval Numbers (FDA) (Report) (BioCentury)
  • Virginia, Oregon Introduce New "Right to Try" Expanded Access Treatment Bills (Virginia) (Oregon)
  • 21st Century Cures Bill Could Create More Prescriptive Rx Approval Standards For FDA (Pink Sheet-$)
  • FDA Says Orally Disintegrating Ibuprofen is a No Go for an ANDA (Lachman)
  • Is Anyone Safe From an FCA Whistleblower Suit? (FDA Law Blog)
  • Study Reveals Lack of Data on Opioid Drugs (Press) (CBS)
  • Researchers propose new regulations for off-label uses of drugs and devices (Medical Xpress)
  • Veloxis Pharmaceuticals Confirms FDA Delay of Envarsus XR (Bidness)
  • Orexo receives paragraph IV notice letter on Abstral in the US (Reuters) (Press)
  • Can MS Drug Tysabri be Transferred Through Breast Milk? (PubMed)
  • Drug Smugglers Jailed on FD&C Act Charges (TimesEnterprise)
  • FDA: Need Relief From Overactive Bladder Symptoms? (FDA)

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

  • Auspex Pharmaceuticals Receives FDA Orphan Drug Designation of SD-809 for Treatment of Tourette Syndrome in the Pediatric Population (Press)

US: Pharmaceuticals and Biotechnology: General

  • Opioid Abuse in US Leveling Off (NEJM) (Reuters) (MedPage Today) (CDC)
  • Big Pharma faces up to new price pressure from aggressive insurers (Reuters)
  • Drug disposal not our problem, industry tells Supreme Court (In-Pharma)

US: Medical Devices

US: Dietary Supplements

  • Hawaii Hepatitis Outbreak: Will DOJ Prosecute USPlabs? (NPI)
  • Supplement GMP Violations Stop Mexican Firm’s Herbal Imports (Tan Sheet-$)

US: Assorted And Government

  • Institute of Medicine Urges Broader Sharing of Clinical Trial Data (Pharmalot) (IOM Report) (IOM) (SCRIP-$) (Vox) (AllTrials) (ModernHealthcare)
  • Path to cures: More unfunded FDA, NIH mandates? (SCRIP-$)
  • FDA Press Releases – 2014 What They Said and How They Said It (Eye on FDA)
  • New Batch of FDA Warning Letters Posted (FDA)
  • Police search for man who posed as FDA agent and raped woman who advertised a massage on Craigslist (amNY)

Upcoming Meetings

Europe

  • How well does EU notified body database NANDO stand up under harsh climes? Commission in the hot seat (Clinica-$)
  • Final opinion - Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices (SCENIHR)
  • EU Commission to part-fund authorities’ medtech market surveillance programs (Clinica-$)
  • Italian pharmacists likely to defy EU's ruling on over the counter morning-after pill (Independent)
  • PRAC Concludes Safety Review of Ambroxol, Bromhexine Meds (Medscape)
  • New case study illustrates how MHRA and OxSonics help cancer drugs to go the extra mile (MHRA)
  • Boehringer complaint ruled out by PMCPA (Pharmafile)
  • PhEur 8th Edition: 3 monographs will be suppressed on 1 January 2016 (EDQM)

India

China

  • Key China Regulatory Agenda For January (PharmAsia-$)

Other International

  • WHO guidance aims to help regulators identify 'false' biosimilars (SCRIP RA-$)
  • IMDRF Wants User Feedback For Medical Device Single Audit Program (Silver Sheet-$)

General Regulatory And Interesting Articles

  • The Forgotten Heroes of Penicillin Batch Safety Testing: Rabbits (Vox)

Regulatory Reconnaissance #472 – 15 January 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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