Regulatory Focus™ > News Articles > Regulatory Recon: DEA Relaxes Marijuana Research Restrictions, India Revamps List of Essential Medic

Regulatory Recon: DEA Relaxes Marijuana Research Restrictions, India Revamps List of Essential Medicines (24 December 2015)

Posted 24 December 2015 | By Michael Mezher 

Regulatory Recon: DEA Relaxes Marijuana Research Restrictions, India Revamps List of Essential Medicines (24 December 2015)

Note from the Editor: We're off enjoying the holidays through next week, Regulatory Recon will be back on 4 January 2016. Happy Holidays!

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

In Focus: US

In Focus: International

  • India adds more cancer, HIV/AIDS drugs to essential medicines list (Reuters) (Economic Times) (24 Insight)
  • Pill Prices Are Hiked Up All The Time In The Low-Income World (NPR)
  • Nigeria: NAFDAC - Promoting Robust Scientific Education (All Africa)
  • EU 2015: Tough Year For Notified Bodies and For Negotiations On New Regulations (Clinica-$)

US: Pharmaceuticals and Biotechnology

  • Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance (FDA)
  • PDUFA VI: Innovative Trial Design Proposal Includes Modeling, Simulation (Pink Sheet-$)
  • The biosimilars are coming. But how long will it be till they can make their mark? (FiercePharma)
  • Prime Therapeutics picks both PCSK9s (BioCentury)
  • DNA Manufacturing Enters the Age of Mass Production (IEEE Spectrum)
  • Purified marijuana compound may reduce stubborn epileptic seizures (Reuters)
  • Pediatric Medication Poisonings More Likely in Poor, Rural Areas (DD&D)

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

  • Merz North America Announces FDA Approval Of XEOMIN® (incobotulinumtoxinA) For Treatment of Adult Upper Limb Spasticity (Press)
  • Transgene announces publication in "The Lancet Oncology" of Phase 2b time trial results with TG4010 immunotherapy in non-small cell lung cancer (MNT)
  • Eagle Pharmaceuticals Announces FDA Approval of Docetaxel Injection, Non-Alcohol Formula (Press)

US: Medical Devices

  • Global biomarker market projected to reach $53.6B by 2020 (MedCityNews)
  • ED-530XT Duodenoscopes by FUJIFILM Medical Systems, U.S.A.: Safety Communication - FUJIFILM Medical Systems Validates Revised Reprocessing Instructions (FDA)
  • Class 1 Recall: Boston Scientific, Chariot Guiding Sheath May Break off During the Procedure (FDA)
  • Class 1 Recall: Draeger Perseus A500 Anesthesia Workstation - Faulty Power Switch May Cause Device to Stop Working (FDA)
  • Class 1 Recall: Insulet Corporation OmniPod Insulin Management System: Needle May Fail to Deliver Insulin (FDA)
  • Why It's Such a Big Deal That Mainstream Glucometers are Going Wireless (medGadget)
  • FDA approves BIOTRONIK Iperia ICD Systems with Full-Body ProMRI Technology (MNT)
  • FDA approval enables Biotronik to enter the crowded peripheral stent market(FierceMedicalDevices)
  • Class 1 Device Recall: Critical Car Ventilator (FDA)
  • Class 1 Device Recall: Etest (FDA 1, 2, 3, 4)

US: Assorted and Government

  • Senate chairman: Cures bill is next priority (The Hill)
  • FDA's Requirement For Nutritional Labels On Craft Beers Is Sobering, Maybe (Lexology)
  • "Destroying Things Is Much Easier Than Making Them" – The Worst Prescription Drug/Medical Device Decisions of 2015 (Drug and Device Law)
  • Propriety of Certificate of Correction Requires Assessment of Teachings of Specification as Whole (National Law Review)
  • Happy Holidays to "Relator" (Drug and Device Law)
  • Trade Groups Back Warner Chilcott In 3rd Circ. Doryx Row (Law360-$)

Upcoming Meetings and Events              

Europe

  • NICE okays ezetimibe for hypercholesterolemia (PharmaLetter-$)
  • Avedro Announces CE Mark Clearance for its Mosaic Advanced Cross‐Linking System and CEO Transition (Press)

India

Japan

Australia

  • Australia bets $1B on pricey hep C drugs in broad effort to eradicate the disease (FiercePharma)

Canada

  • Summary Safety Review - AVONEX (interferon beta-1a) - Assessing the Potential Risk of Clots in Small Blood Vessels (thrombotic microangiopathy) (Health Canada)
  • Canada Says Lilly Seeks 'Uber-Tribunal' In $500M IP Fight (Law360-$)

Other International

  • Brazil declares emergency after 2,400 babies are born with brain damage, possibly due to mosquito-borne virus (Washington Post)
  • Fresh start for Liberian chimpanzees used for medical tests (Reuters)

General Health and Other Interesting Articles

  • Illegal Trade In Tiny Pet Turtles Keeps Spreading Salmonella (NPR)
  • Ecologist Finds Another Cause of Antibiotic Resistance (ICT)
  • World's First Clinical Guidelines for Chronic Fungal Lung Infections are Available (ICT)
  • Brain Cancers Reveal Novel Genetic Disruption in DNA (NYTimes)

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.


Categories: Recon, Regulatory News

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