Regulatory Focus™ > News Articles > Regulatory Recon: Buggy Batch of Saline Gets Recalled (21 July 2015)

Regulatory Recon: Buggy Batch of Saline Gets Recalled (21 July 2015)

Posted 21 July 2015 | By Michael Mezher 

Regulatory Recon: Buggy Batch of Saline Gets Recalled (21 July 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher and @RAPSorg on Twitter.

In Focus: US

  • Insect Discovery in IV Solution Bags Prompts Recall (MPR) (FiercePharmaManufacturing) (FDA)
  • Efficient OTC Pathway Needs NDA Flexibility, Monograph Scope – Sharfstein (Tan Sheet-$)
  • NIH: Early antiretroviral benefits go beyond AIDS prevention (SCRIP-$) (NIH)
  • Judging a Pill by Its Color (WSJ)
  • Rising U.S. Drug Prices Are Focus of Research Grant (WSJ)
  • Does high TV ad rotation give patients the wrong idea about drugs? (FiercePharmaMarketing)
  • The Shrinking Value Of Best-In-Class And First-In-Class Drugs (In Vivo)
  • CDRH Sets Date To Examine Patient-Focused Device Labeling Policies (Gray Sheet-$)
  • Senate Bill Aimed At Streamlining Combo Product Regulation (Gray Sheet-$)
  • 510(k) Reform on a High Wire (MDDI)
  • Podcast: Fighting Depression With Medical Devices (MassDevice)

In Focus: International

  • Guideline on core SmPC and Package Leaflet for sodium fluoride (EMA)
  • EMA Labeling Principles Seek To Define When To 'Go Broader Or Narrower' (Pink Sheet-$)
  • Re-manufacture of single use devices: Survey on draft guidance (MHRA)
  • Swissmedic updates guidance on medical device clinical trials (Clinica-$)
  • Singapore's Biopharma Industry: Where the Jobs Are (FiercePharmaAsia)

US: Pharmaceuticals and Biotechnology

  • FDA Modifies Tikosyn REMS Requirements (MPR)
  • How Express Scripts plans to do indication-based pricing for cancer drugs (BioCentury-$)
  • Efficient OTC Pathway Needs NDA Flexibility, Monograph Scope – Sharfstein (Tan Sheet-$)
  • NIH: Early antiretroviral benefits go beyond AIDS prevention (SCRIP-$) (NIH)
  • Insect Discovery in IV Solution Bags Prompts Recall (MPR)
  • Ibrance Illustrates Heavy FDA Workload For 'Breakthrough' Reviews (Pink Sheet-$)
  • ANDA Refuse-to-Receive Challenges Become More Common – And More Successful (Pink Sheet-$)

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

  • Delcath Gets Orphan Nod From FDA for Melphalan (MassDevice) (Press)
  • Adaptimmune Touts a Promising Snapshot of TCRs for Myeloma (FierceBiotech) (Press)
  • Boston Scientific Initiates Study Evaluating New Fully Resorbable Scaffold Technology (Press)
  • Inhaled Cannabis for Neuropathic Pain: Results From First-of-Kind Study (MPR)

US: Pharmaceuticals and Biotechnology: General

  • Judging a Pill by Its Color (WSJ)
  • Rising U.S. Drug Prices Are Focus of Research Grant (WSJ)
  • Paper Shadow Charts: Hidden Barrier to eSource in Risk Based Monitoring (MedCityNews)
  • Drug Shortage Regulation: Incentive for Development of “Unapproved” Drugs? (The 505(b)(2) Blog)
  • Follow-On Biologics: Another Ho-Hum Assessment (Health Business Blog)
  • Does high TV ad rotation give patients the wrong idea about drugs? (FiercePharmaMarketing)
  • The Shrinking Value Of Best-In-Class And First-In-Class Drugs (In Vivo)

US: Medical Devices

  • CDRH Sets Date To Examine Patient-Focused Device Labeling Policies (Gray Sheet-$)
  • Senate Bill Aimed At Streamlining Combo Product Regulation (Gray Sheet-$)
  • UCLA adopts startup cleaning system to help stop spread of superbugs via duodenoscopes (FierceMedicalDevices)
  • FDA and UL weigh in on security of medical devices, IoT (TechTarget)
  • Class 1 Device Recall Portable Oxygen System regulators (FDA)
  • 510(k) Reform on a High Wire (MDDI)
  • FDA Microneedling Regulations Status Update (FDA Atty)
  • Podcast: Fighting Depression With Medical Devices (MassDevice)
  • Boston Scientific heads to the clinic with its first bioabsorbable, drug-eluting coronary scaffold (FierceMedicalDevices)
  • Blood-based liquid biopsies are the new frontier in cancer diagnosis (FierceMedicalDevices)
  • Abbott wins FDA nod for Lasik device (MassDevice)
  • NIH-backed scientists develop wireless, remote-controlled brain implant (FierceMedicalDevices)
  • St. Jude Medical - FDA Approval for First MR-Conditional 5-Column Paddle Lead for Chronic Pain (Press)
  • Hospitals to Trial AliveCor's iPhone-Enabled ECG for Diagnosis of Heart Attacks (FierceMedicalDevices)
  • Early study results indicate EndoStim's implant is effective for treating acid reflux (FierceMedicalDevices)

US: Assorted and Government

  • House Dems Say Obama's Trade Deal Threatens Public Health (MedpageToday)

Upcoming Meetings and Events

Europe

  • Guideline on core SmPC and Package Leaflet for sodium fluoride (EMA)
  • EMA Labeling Principles Seek To Define When To 'Go Broader Or Narrower' (Pink Sheet-$)
  • Re-manufacture of single use devices: Survey on draft guidance (MHRA)
  • Swissmedic updates guidance on medical device clinical trials (Clinica-$)
  • EC approves nivolumab for squamous NSCLC (BioCentury-$) (Press)
  • Cons Of 'Brexit' For Pharma Could Far Outweigh Pros (Pink Sheet-$)
  • Human Medicines Regulations 2012 Advisory Bodies annual report 2014 (MHRA)
  • New members sought for the British Pharmacopoeia Commission (MHRA)
  • EC approves Amgen’s cholesterol-lowering medication Repatha (European Pharmaceutical Review)
  • Results of Phase 2 study of lonafarnib in HDV infected patients published (European Pharmaceutical Review)

India

  • Drug exports from India to have embedded tracking chips (Hindustan Times)
  • India expands drug pricing with caps for two antibiotics (FiercePharma)

China

  • OrbusNeich Launches Chinese Combo Stent Trial (MassDevice)

Japan

  • Japan Approves BioSpecifics’ Dupuytren's Contracture Treatment (BioSpectrum)

Australia

  • Australian Regulators End Transition Period for Reclassification of Joint Replacement Devices (Emergo)

Ebola Outbreak

  • Liberia: Ebola Patients Discharged, Last of the Country’s Latest Wave (NYTimes)

Other International

  • Singapore's Biopharma Industry: Where the Jobs Are (FiercePharmaAsia)
  • Women Respond Well to Daily HIV Prevention Pill in South African Study (MedpageToday)

General Regulatory and Interesting Articles

  • How ‘Medical’ Is Marijuana? (NYTimes)
  • New Marijuana Industry Wrestles With Pesticides and Safety (Boston Herald)
  • How Healthy is the Field of Total Synthesis? (In the Pipeline)
  • French Teen’s HIV in Remission Despite Stopping Treatment as a Child (Washington Post)
  • Leading scientists call for new approach to research reporting (MNT)
  • Berg: Using artificial intelligence for drug discovery (MedCityNews)
  • Two Tools To Grow Your Influence As A Leader (Life Science Leader)

Regulatory Reconnaissance #600– 21 July 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 @Michael_Mezher 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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