Regulatory Focus™ > News Articles > Regulatory Recon: FDA Effort to Block Counterfeit Drug Sales Runs Into Problems (28 October 2014)

Regulatory Recon: FDA Effort to Block Counterfeit Drug Sales Runs Into Problems (28 October 2014)

Posted 28 October 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: FDA Effort to Block Counterfeit Drug Sales Runs Into Problems (28 October 2014)

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

In Focus: US

  • Icann, FDA Clash Over Illegal Online Drug Sales (WSJ-$)
  • U.S. judge slashes $9 billion award vs Takeda, Lilly over diabetes drug (Reuters)
  • Women Press FDA to Encourage Sexual Dysfunction Drugs (WSJ-$)
  • Legal Experts Tout Need For More FDA Authority To Respond To Drug Shortages (IHP-$)
  • St. Jude Medical snags FDA approval for next-generation ablation catheter (Fierce) (MDDI) (Star Tribune)
  • CDRH Holds Webinar on Draft LDT Guidances – Highlights that Guidances Hold More Questions than Answers (FDA Law Blog)

In Focus: International

  • In race for Ebola vaccines, technical and regulatory hurdles loom large (Reuters)
  • Saatchi Medical Innovation Bill must include off-label drug use, says peer (Pharma Times)
  • Adoption of EU Device Regulations Slower Than Expected But Changes Already Happening (Clinica-$)
  • Indian Govt seeks representation from industry to reform policy on medical device sector (PharmaBiz)
  • Should energy drinks be age-restricted like alcohol? WHO official asks in report (Nutra-Ingredients)

US: Pharmaceuticals and Biotechnology

  • Icann, FDA Clash Over Illegal Online Drug Sales (WSJ-$)
  • U.S. judge slashes $9 billion award vs Takeda, Lilly over diabetes drug (Reuters)
  • Women Press FDA to Encourage Sexual Dysfunction Drugs (WSJ-$)
  • Legal Experts Tout Need For More FDA Authority To Respond To Drug Shortages (IHP-$)
  • Background Analysis: US FDA Advisory Committee to Review Blood Donor Policies Involving MSM, Chikungunya Virus Infections, and MERS-CoV (Tarius)
  • A Review of the Status of Biosimilars in the U.S. (National Law Review)
  • Sarepta Needs FDA Expertise, Stat (Forbes)
  • DEA Removes Naloxegol from Control Schedule (DEA)
  • The evolution of the regulatory framework for antibacterial agents (Wiley)
  • Drug Exclusivity, Incentives On The Table As House 'Cures' Effort Advances (IHP-$)
  • Teva Sues Chicago to Block Disclosure of Marketing Plan Amid Opioid Case (FDA News-$)
  • Want a flu shot? Supplies run low amid shipment delays (CBS) (Fierce)
  • In Men’s Fight Against Aging, How Much Risk to Take? (WSJ-$)
  • Ranbaxy Still Working to Fix Quality Issues (Reuters)

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

  • Receptos bowel disorder drug meets mid-stage trial goal (Reuters) (Fierce)
  • Araim Pharmaceuticals Given FDA Fast Track Designation to ARA 290 for the Treatment of Sarcoidosis-associated Small Fiber Neuropathy (Press)

US: Pharmaceuticals and Biotechnology: General

  • Report: Pharma companies have many apps, relatively few downloads (MobiHealthNews)
  • Novartis sees new heart failure drug as 'multi-blockbuster' (Reuters)

US: Medical Devices

  • St. Jude Medical snags FDA approval for next-generation ablation catheter (Fierce) (MDDI) (Star Tribune)
  • CDRH Holds Webinar on Draft LDT Guidances – Highlights that Guidances Hold More Questions than Answers (FDA Law Blog)
  • FDA Webinar on the Custom Device Exemption Guidance (FDA)
  • Wright Gets FDA Approvable Letter For Augment Bone Graft (Press)
  • Bad Tumor Markers Equal to Bad Drugs (MedPage Today)
  • Zyno Medical Single-Use Ambulatory Infusion Pump FDA Cleared (MedGadget)
  • Dallen Medical Receives FDA Clearance for Tensyn Band for AC/CC Joint Stabilization (Press)

US: Dietary Supplements

  • Medications, Dietary Supplements Potentially Dangerous Mix, FDA Says (NPI) (FDA)
  • FDA ‘Struggles’ Against Spiked Supplements, ‘Thorn’ In Industry’s Side (Tan Sheet-$)
  • Experts not surprised steroid-tainted supplements lingered on market following recalls (NutraIngredients)
  • Hatch Marks 20th Anniversary of the Dietary Supplement Health and Education Act (DSHEA) (Press)
  • Think Twice Before Consuming Herbal Products (USP)

US: Assorted And Government

  • FDA Commissioner talks life balance, Ebola (Yale Daily)
  • FDA Awarding Contract to Expert Witness Support Company (FDA)

Upcoming Meetings

Ebola Outbreak

  • In race for Ebola vaccines, technical and regulatory hurdles loom large (Reuters)
  • WHO: Millions of Ebola Vaccine Doses Ready in 2015 (AP)
  • Biotech Co. Misled Investors About Role In Ebola Drug: Suit (Law 360-$)

Europe

  • Saatchi Medical Innovation Bill must include off-label drug use, says peer (Pharma Times)
  • EMA Clinical Data Disclosure Plan Under Fire (PharmExec)
  • Adoption of EU Device Regulations Slower Than Expected But Changes Already Happening (Clinica-$)
  • Guidance on the assessment of persistent, bioaccumulative and toxic or very persistent and very bioaccumulative substances in veterinary medicine (EMA)
  • New policy for testing for bacterial endotoxins (EDQM)
  • EDQM 50th anniversary International Conference - Follow up (EDQM)
  • Coming soon – EDQM's New Standard Terms database (EDQM)

India

  • Indian Society Calls for Ban on Codeine (India Times)
  • Govt seeks representation from industry to reform policy on medical device & plastics sector (PharmaBiz)
  • India’s State Assembly Elections And Their Impact On The Life Sciences Industry (Two-Four Insight)
  • DCGI to provide WC certificate to exporters on submission of 6-month stability data (PharmaBiz)

Canada

  • Canadian guidelines recommend against prostate cancer test (Reuters)

Other International

  • Should energy drinks be age-restricted like alcohol? WHO official asks in report (Nutra-Ingredients)
  • EOS imaging Obtains Marketing Approval in South Korea (Press)

Clinical Trials

General Regulatory And Interesting Articles

  • New Research Shows Your Body Clock May Influence How Many Drugs Work (Forbes)
  • Scientific advances are not translating into new cancer drugs, expert warns (PharmJournal)
  • Agave syrup, placebo both better than nothing for little kids' coughs (Reuters)
  • Adverse drug reactions in children following use of asthma medications (PharmaNews.eu)

Regulatory Reconnaissance #428 – 28 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.


Categories: Recon, Regulatory News

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