Regulatory Focus™ > News Articles > Regulatory Recon: WHO Seeking New Policy on Clinical Trials Data Transparency (24 October 2014)

Regulatory Recon: WHO Seeking New Policy on Clinical Trials Data Transparency (24 October 2014)

Posted 24 October 2014 | By Alexander Gaffney, RAC

Regulatory Recon: WHO Seeking New Policy on Clinical Trials Data Transparency (24 October 2014)

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

In Focus: US

  • No FDA Warning Letters For Device Firms Participating In IMDRF Single-Audit Pilot (Gray Sheet-$)
  • FDA Clarifies Oversight Exception For Stem Cell Procedures (Law 360-$)
  • On “Right To Try” Legislation (D&D Law)
  • FDA Official Hints at Potential Quality Metrics and Collection Methods (FDA News-$)
  • Hikma Pharma shares slip on FDA warning for Portugal plant (Reuters) (RTT)
  • FDA Throws Support Behind New Tool to Study Rare Diseases (FDA)
  • Jury clears DePuy in 1st Pinnacle bellwether trial (Mass Device) (Reuters) (Law 360-$) (Law 360-$) (WSJ-$)
  • FDA’s Hollow Medical Device Recall Guidance: Ending Not with A Bang But A Whimper (FDA Law Blog)

In Focus: International

  • WHO Drafting Policy on Clinical Trials Data Reporting Transparency (AllTrials) (BioCentury) (WHO)
  • EMA Recommends Approval of Six New Medicines (EMA)
  • Scenesse recommended for rare disease that causes intolerance to sunlight (EMA) (Reuters)
  • Lynparza recommended for approval in ovarian cancer (EMA) (Press) (Reuters)
  • Head of GSK Ebola Vaccine Research: "Can We Even Consider Doing A Trial?" (Forbes)
  • Ebola Vaccine, Ready for Test, Sat on the Shelf (NYTimes)
  • Fixing 'Ebolanomics' in pursuit of vaccines and drugs (Reuters)

US: Pharmaceuticals and Biotechnology

  • FDA Clarifies Oversight Exception For Stem Cell Procedures (Law 360-$)
  • On “Right To Try” Legislation (D&D Law)
  • FDA Official Hints at Potential Quality Metrics and Collection Methods (FDA News-$)
  • Hikma Pharma shares slip on FDA warning for Portugal plant (Reuters) (RTT)
  • FDA Throws Support Behind New Tool to Study Rare Diseases (FDA)
  • Certara Receives FDA Grant to Enhance Simcyp Simulator’s Mechanistic Dermal Absorption Model to Permit Drug Bioequivalence Assessment (Press)
  • Turning the Page on Zohydro? New Formulations, New Division Leadership Should Help FDA Move Forward in Opioids (RPM Report-$) (Policy and Medicine)
  • Guidance: Qualification for the Use of Galactomannan in Serum and Bronchoalveolar Lavage Fluid (FDA)
  • Traceability of biopharmaceuticals in spontaneous reporting systems: a cross-sectional study in the FDA Adverse Event Reporting System (FAERS) and EudraVigilance databases (PubMed)
  • A Warm Send-Off For FDA’s Rappaport (RPM Report-$)
  • No, Abortion Drugs Aren't Banned in Oklahoma (Reason)
  • Report Pans Military's Blood Management System (DOD IG-PDF)
  • Arbor Pharmaceuticals Announces FDA Approval of Sotylize (Press) (MPR)
  • BioSpace’s Favorite FDA Tricks Or Treats (BioSpace)

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

  • Novartis racks up a new slate of promising PhIII data for secukinumab (Fierce)
  • NPS Pharma says FDA extends review of its drug Natpara by 3 months; decision due Jan. 24 (AP) (Reuters) (Press) (BioCentury)
  • TaiMed Biologics Receives Orphan Drug Designation for Ibalizumab from U.S. FDA (Press)

US: Pharmaceuticals and Biotechnology: General

  • Celgene invests in startup that measures residual cancer cells to test a drug’s efficacy (MedCityNews)

US: Medical Devices

  • No FDA Warning Letters For Device Firms Participating In IMDRF Single-Audit Pilot (Gray Sheet-$)
  • Jury clears DePuy in 1st Pinnacle bellwether trial (Mass Device) (Reuters) (Law 360-$) (Law 360-$) (WSJ-$)
  • FDA’s Hollow Medical Device Recall Guidance: Ending Not with A Bang But A Whimper (FDA Law Blog)
  • FDA Twitter Guidance Lacks Flexibility, And May Be Unconstitutional, Critics Say (Gray Sheet-$)
  • Federal agencies warn against counterfeit decorative contact lenses (ICE)
  • AVACEN Medical Announces FDA Clearance Of First Medical Device With Internal Game Mode (Press)
  • Zyno Medical, LLC Receives FDA 510(k) Clearance for Ambulatory Infusion Pump (Press)
  • Flint Rehabilitation Devices Introduces MusicGlove, World’s First FDA Approved, Clinically Validated Music-Based Hand Rehabilitation Device (Press)
  • Life Spine announces FDA clearance of Long Bow interbody system (Healio)

US: Dietary Supplements

  • DSHEA Sheds Little Light On Distinguishing Old From New Ingredients (Tan Sheet-$)
  • Sen. Brown Demands FDA Ban Powdered Caffeine (WTAM)
  • 5-Hour Energy Knee-Deep In Litigation with Private Plaintiffs, Attorneys General (NPI)
  • Herbal medicines could contain dangerous levels of toxic mold (Press)

US: Assorted And Government

  • E-Cigarettes Spark Evolution Of FDA’s Nicotine-Containing Medical Product Regulation (Tan Sheet-$)

Upcoming Meetings

Ebola Outbreak

  • Head of GSK Ebola Vaccine Research: "Can We Even Consider Doing A Trial?" (Forbes)
  • Ebola Vaccine, Ready for Test, Sat on the Shelf (NYTimes)
  • Fixing 'Ebolanomics' in pursuit of vaccines and drugs (Reuters)
  • Big pharma battles charge of tardiness on Ebola (FT-$)
  • Ebola crisis rekindles concerns about secret research in Russian military labs (WaPo)
  • WHO expects around 200,000 Ebola vaccine doses by mid-2015 (Reuters)
  • Treating Ebola: The Hunt for a Drug (NYTimes)
  • Study to Look at Blood Products From Ebola Survivors as Treatment (WSJ-$)
  • Medical Groups Issue Statement on Processing Biohazardous Waste from Treating Ebola Patients (AAMI)
  • DeSalvo Leaving ONC To Work On U.S. Ebola Response (Forbes)
  • EU names coordinator to step up response to Ebola (Reuters)
  • Paul Allen pledges $100 million to fight Ebola (CNBC)
  • U.S. government grants five open Ebola waste permits (Reuters)

Europe

  • EMA Recommends Approval of Six New Medicines (EMA)
  • Scenesse recommended for rare disease that causes intolerance to sunlight (EMA) (Reuters)
  • Lynparza recommended for approval in ovarian cancer (EMA) (Press) (Reuters)
  • EMA recommends further measures to minimise risk of blood vessel blockage with Iclusig (EMA) (Reuters)
  • European Medicines Agency completes review of polymyxin-based medicines (EMA)
  • Starting debate: EMA says rules on API materials need clarification (In-Pharma)
  • EMA updates Pre-Authorisation Procedural Advice for CP users (Exalon)
  • What Disease Condition had the Most Positive Reviews from NICE? (Context Matters)
  • How NICE can get innovative cancer meds into NHS (PharmaTimes)

Australia

  • Expert review of medicines and medical devices regulation (TGA)
  • GSK's Zovirax Ophthalmic Ointment Recalled (MNT)
  • Australian TGA updates eCTD FAQ (Exalon)

Other International

Clinical Trials

  • Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care (HHS)
  • Were clinical trial practices in East Germany questionable? (MNT)

Regulatory Reconnaissance #426 – 24 October 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.


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