Regulatory Focus™ > News Articles > Regulatory Recon: FDA's Rules for Marijuana Studies (20 June 2014)

Regulatory Recon: FDA's Rules for Marijuana Studies (20 June 2014)

Posted 20 June 2014 | By Alexander Gaffney, RAC

Regulatory Recon: FDA's Rules for Marijuana Studies (20 June 2014)

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

In Focus: US

  • Going to Pot: FDA Explains its Stance on Marijuana and its use in Clinical Trials (FDA) (FDA) (FDA)
  • FTC Warns REMS Abuse Not Safe From Antitrust Law (Law 360-$)
  • 'ADAPT': A Regulatory Pathway to Develop Antibiotics and Fight Drug Resistant Infections (Pew)
  • A Type of Rx Drug Tweet FDA Did Not Consider in its Recent Guidance (Pharma Marketing Blog)
  • Report Claims iWatch Awaiting FDA Approval (MacRumors)

In Focus: International

  • EU medical device reform talks could start end of 2014/beginning of 2015 (Clinica-$)
  • EMA GMP inspectors working group making updates for this year (Fierce)
  • Eucomed Pleased with EU Commissions Conclusions on Joint Plan for Immediate Actions for Medical Devices (Eisner)
  • Wockhardt Raids Competitors To Deal With Quality-Production Problems (PharmAsia-$)
  • Bayer’s Nexavar cleared in Japan for differentiated thyroid cancer (Pharma Letter-$) (Press)
  • African Union's NEPAD establishes centres of excellence to help strengthen regulatory capacity development (PharmAfrica)

US: Pharmaceuticals and Biotechnology

  • Going to Pot: FDA Explains its Stance on Marijuana and its use in Clinical Trials (FDA) (FDA) (FDA)
  • FTC Warns REMS Abuse Not Safe From Antitrust Law (Law 360-$)
  • 'ADAPT': A Regulatory Pathway to Develop Antibiotics and Fight Drug Resistant Infections (Pew)
  • A Type of Rx Drug Tweet FDA Did Not Consider in its Recent Guidance (Pharma Marketing Blog)
  • Provectus Breakthrough Denial Is Symptom Of a Different Breakthrough at FDA (RPM Report-$)
  • FDA Takes Steps to Ease Drug Shortage (Schumer)
  • Research Expert: FDA Should Reconsider Use Of Term 'Breakthrough' (IHP-$)
  • Can the pursuit of biosimilar interchangeability go too far? (GaBi)
  • FDA Leverages Big Data Via Cloud Computing (FDA)
  • FDA’s MedWatch Safety Alerts: May 2014 (FDA)
  • FDA Announces Minor Use/Minor Species Grant Program Request for Applications due August 15, 2014 (FDA)
  • Safe Use of Flea and Tick Products in Pets (FDA)

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

US: Pharmaceuticals and Biotechnology: General

  • Congressional call for hearings on Sovaldi Part D impact (BioCentury) (The Hill) (Pink Sheet-$) (Letter)
  • The Nuts and Bolts of Preparing For and Managing DEA Cyclic Inspections: What Every Registrant Should Know (FDA Law Blog)
  • The Role Of Sales Representatives In Driving Physicians’ Off-Label Prescription Habits (Health Affairs)
  • Purchasers Blast Wyeth's Immunity Bid In Pay-For-Delay Suit (Law 360-$)
  • Rahm Emanuel's War on Painkillers (Bloomberg)
  • 5 states plan online registry to share prescription drug data (Fierce)
  • 15 Highest-Paid Biopharma CEOs of 2013 (Fierce)

US: Medical Devices

  • Report Claims iWatch Awaiting FDA Approval, Will Feature Blood Glucose and Sweat Sensors (MacRumors)
  • As sequencing moves into clinical use, insurers balk (Reuters)
  • Sorin Group: ANSWER Study Shows That SafeR(TM) Safely Reduces Right Ventricular Pacing in Pacemaker Patients and Subsequently Improves Clinical Outcomes (Press)
  • US: Assorted And Government
  • Anthrax exposure possible at CDC labs in Atlanta (USA Today) (Reuters) (SCRIP-$) (NBC)

Europe

  • EU medical device reform talks could start end of 2014/beginning of 2015 (Clinica-$)
  • EMA GMP inspectors working group making updates for this year (Fierce)
  • Eucomed Pleased with EU Commissions Conclusions on Joint Plan for Immediate Actions for Medical Devices (Eisner)
  • UK’s NICE draft guidance recommends Lilly’s Efient (Pharma Letter-$)
  • Novartis Pulls Galvus From Germany After Failed Price Negotiations (Pink Sheet-$)

India

  • Wockhardt Raids Competitors To Deal With Quality-Production Problems (PharmAsia-$)
  • AIDCOC wants govt to appoint only technically qualified person in drugs dept (PharmaBiz)

Japan & China

  • Bayer’s Nexavar cleared in Japan for differentiated thyroid cancer (Pharma Letter-$) (Press)
  • China’s Hisun Gets Capreomycin WHO Prequalification (PharmAsia-$)

Other International

  • African Union's NEPAD establishes centres of excellence to help strengthen regulatory capacity development (PharmAfrica)
  • Restrictions on antimicrobial use in food animal production: an international regulatory and economic survey (PubMed)
  • Global biosimilar regulations diverging, experts say (Biopharma Reporter)

Clinical Trials

  • The Challenge of Recruiting Patients of Alzheimer's Studies (WaPo)
  • Clinical researchers dip toe into social media (MM&M)

General Regulatory And Interesting Articles

  • To Defeat A Deadly Toxin, Disrupt Its Landing Gear (NPR)

Regulatory Reconnaissance #341 – 20 June 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.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

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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