Regulatory Focus™ > News Articles > Regulatory Recon: How Social Media Complicates Compassionate Use (28 August 2014)

Regulatory Recon: How Social Media Complicates Compassionate Use (28 August 2014)

Posted 28 August 2014 | By Alexander Gaffney, RAC

Regulatory Recon: How Social Media Complicates Compassionate Use (28 August 2014)

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

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In Focus: US

In Focus: International

  • India Enters The 'Pay-For-Delay' Fray (Law 360-$)
  • IMDRF Closes Work Items on Recognized Standards, UDI Roadmap (IMDRF)
  • UK NICE wants more info on type 2 diabetes drug Jardiance (Pharma Letter-$) (Pharma Phorum) (Pharma Times)
  • UK Cancer Drugs Fund budget increased – but pharma prices to be challenged (Pharma Phorum) (Pharmafile) (UK Gov)
  • Girls in Colombian town struck by mystery illness, GSK's Guardasil Implicated (WaPo)

US: Pharmaceuticals and Biotechnology

  • Rescue Me: The Challenge Of Compassionate Use In The Social Media Era (Health Affairs) (Forbes)
  • ISPE Launches New Drug Shortage Plan (ISPE)
  • Aegerion says FDA investigation into off-label marketing is closed (BioFlash) (Pink Sheet-$)
  • What does the FDA say regarding glass delamination prevention? (ECA)
  • Costly Drugs Prompt Attention To QALY Value Measure In U.S. – Tufts/Harvard Experts (Pink Sheet-$) (Tufts) (NEJM)
  • Biosimilar Nomenclature: Can We Achieve the Truth, the Whole Truth, & Nothing but the Truth? (FDLI)

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

  • Amgen Submits Biologics License Application For Novel Investigational LDL Cholesterol-Lowering Medication Evolocumab To The FDA (Press)
  • FDA Removes Partial Clinical Hold on OncoMed Pharmaceuticals' Vantictumab (Press) (Reuters)
  • Repros says its testosterone drug found superior in study (Reuters)
  • Pfizer’s Investigational Vaccine Candidate for Clostridium difficile Receives FDA Fast Track Designation (Press)
  • Amgen gets Priority Review for ivabradine (BioCentury) (MedCityNews) (Pharma Times) (Press) (SCRIP-$)
  • Treatment for Spinal Cord Injury To Start Clinical Trial Funded by California’s Stem Cell Agency (CIRM) (Press)
  • ACADIA Pharmaceuticals Announces Trade Name NUPLAZID for Pimavanserin (Press)

US: Pharmaceuticals and Biotechnology: General

  • NIH issues final policy on genomic data sharing (BioCentury) (NIH) (FR)
  • PhRMA Must Restart Suit Over 340B Orphan Drug Rule (Law 360-$) (FDA Law Blog)
  • New trial ordered for soldier who says anti-smoking drug drove him to kill (SacBee)
  • Painkiller maker Acura gets NIH grant for Abuse Resistance (MM&M)
  • Who's worried about the drug-pricing debate? Regeneron's CEO, for one (Fierce)

US: Medical Devices

  • DePuy Synthes gets FDA's highest-risk warning after 15 complaints (Mass Device) (Reuters)
  • How the FDA regulates 3-D printed devices (FedScoop)
  • Shareholders sue Edap following FDA slip (Mass Device)
  • ReShape targets U.S. approval as EU study shows major weight loss (Fierce)
  • Predicting PARADIGM-HF, Or What To Expect When You're Expecting (Forbes)
  • CardiacAssist Receives FDA 510(k) Clearance for Its PROTEK Duo Veno-Venous Cannula (Press)
  • Miraculins Inc. Planning De Novo Submission for Scout DS Device (Press)
  • MicroVention’s LVIS and LVIS Jr. Stents FDA Approved to Treat Brain Aneurysms (MedGadget)

US: Dietary Supplements

  • Working with FDA for Successful Outcomes Post-Inspection (NPI)

US: Assorted And Government

  • FDA Internal Meeting Means Public Meetings Off Campus (RPM First Take)
  • White House orders immediate 'sweep' of infectious agent labs (SCRIP-$)
  • Government Wants a 12-Acrea Marijuana Farm (TIME)

Ebola Outbreak

Europe

  • European approval for Velphoro (BioCentury) (SCRIP-$)
  • UK Cancer Drugs Fund budget increased – but pharma prices to be challenged (Pharma Phorum) (Pharmafile) (UK Gov)
  • UK NICE wants more info on type 2 diabetes drug Jardiance (Pharma Letter-$) (Pharma Phorum) (Pharma Times)
  • Report on the EMA workshop of pharmacovigilance in the paediatric population (EMA)
  • European Pharmacopoeia Enquiry – AIM and EDA in the Quality Control of Inhaled Drug Products (EDQM)

India

  • India Enters The 'Pay-For-Delay' Fray (Law 360-$)
  • MSF upset over inclusion of IP in ongoing negotiations of Regional Comprehensive Economic Partnership (PharmaBiz)

Canada

  • Canadian prescription drug crisis: opioid use per capita second to US (Beacon)

Other International

  • IMDRF Closes Work Items on Recognized Standards, UDI Roadmap (IMDRF)
  • Girls in Colombian town struck by mystery illness, GSK's Guardasil Implicated (WaPo)
  • OEP Philippines Orders Recall Of Angina Drug (PharmAsia-$)

Clinical Trials

General Regulatory And Interesting Articles

  • DARPA Project Starts Building Human Memory Prosthetics (IEEE)
  • In India, surgeons use 3-D printed skull for practice (Fierce)
  • Electromagnetic Warfare Is Here (IEEE)

Regulatory Reconnaissance #388 – 28 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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