Regulatory Focus™ > News Articles > Regulatory Reconnaissance: FDA Dials Back on Use of REMS (13 May 2014)

Regulatory Reconnaissance: FDA Dials Back on Use of REMS (13 May 2014)

Posted 13 May 2014 | By Alexander Gaffney, RAC 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org.

In Focus: US

  • FDAAA Fading? REMS Use Continues To Decline As Drug Safety Law Matures (RPM Report-$)
  • Navigating the "Country of Origin" Question for Pharmaceutical Products (Reed Smith)
  • Fake OTCs becoming more common, says ex-DOJ prosecutor (In-Pharma)
  • FDA clears prescription video game for rehabilitation therapy (Fierce) (Bloomberg)
  • 4 Regulatory Challenges Facing IVD Companies Today (MDDI)
  • FDA Panel to Review Rejection of FzioMed's Oxiplex (FDA)
  • How FDA Made Red M&M's Disappear for a Decade (Priceonomics)

In Focus: International

  • Japanese officials: Novartis failed to report side effects of leukemia drug (Fierce)
  • CFDA Says Regulatory Reform Needs Market Push (PharmAsia-$)
  • Scottish Medicines Consortium recommends three drugs but rejects Remicade  (SCRIP-$)
  • Journal: Industry, Not Health Canda, Behind Access Delays (Press) (CBC)
  • Australia Opens Consultation on IMDRF Software Proposal (TGA)

US: Pharmaceuticals/Biotechnology

  • FDAAA Fading? REMS Use Continues To Decline As Drug Safety Law Matures (RPM Report-$)
  • Navigating the "Country of Origin" Question for Pharmaceutical Products (Reed Smith)
  • Fake OTCs becoming more common, says ex-DOJ prosecutor (In-Pharma)
  • Opinion: Fix the FDA, Fix Patents, Save Lives (Forbes)
  • FDA Concludes Review of Osteoporosis Drugs, Says Consumers May be Able to Stop After Few Years (FDA)
  • Arizonans will vote on right-to-try drugs measure (AZ Central)
  • A Close Call: FDA's Decision Memo On The Approval of Chelsea Therapeutics' Northera (RPM Report-$)
  • FDA, Drug Companies Struggle with Compassionate Use Requests (PharmTech)
  • FDA, Ipsen Working to Increase Supply of Childhood Cancer Drug Increlex (Press)
  • FDA holding workshop on immune response to ERTs (BioCentury) (FDA)
  • Costs from FDA actions undermine Ranbaxy's earnings (Fierce) (Pharmafile)
  • FDA Approves Perrigo's Generic Astepro Nasal Spray (Press)
  • Amgen Names Senior Vice President, Global Regulatory Affairs And Safety (PharmPro)

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

  • Lilly draws flak after touting PhIII diabetes success for Lantus rival (Fierce) (Reuters) (BioCentury) (Bloomberg)
  • GlaxoSmithKline's blockbuster dreams dashed as darapladib goes 0-for-2 in PhIII (Fierce) (Reuters) (Press)
  • Sandoz preparing to file biosimilar Neupogen/Neulasta in US (SCRIP-$)
  • Taiho to file colorectal cancer combo following positive PhIII data (SCRIP-$)
  • Tesaro gains on final Phase III data for oral rolapitant (BioCentury) (BioFlash) (Xconomy)
  • AstraZeneca announces positive results from Phase III study of saxagliptin/dapagliflozin combination in patients with type 2 diabetes (Press)
  • Santhera Announces Successful Outcome of Phase III Study with Catena(R)/Raxone(R) in Duchenne Muscular Dystrophy (Press)
  • Cubist's antibiotic for gram-negative infections meets goals in two pivotal studies (MedCity news)
  • Panel Supports Halozyme Continuing Pancreatic-Cancer-Treatment Study (WSJ-$)
  • FDA Grants Abeona's Sanfilippo Syndromes Drugs Orphan Drug Status (DD&D)
  • FDA grants fast track status for Prima BioMed's CVac (PBR)
  • Teva Announces FDA Acceptance of sNDA Filing for Pediatric Indication for QNASL (Beclomethasone Dipropionate) Nasal Aerosol (Press)
  • Janseen Submits sNDA for Once-Monthly Long-Acting Therapy INVEGA SUSTENNA (paliperidone palmitate) for the Treatment of Schizoaffective Disorder (Press)

US: Pharmaceuticals and Biotechnology: General

US: Medical Devices

  • FDA clears prescription video game for rehabilitation therapy (Fierce) (Bloomberg)
  • 4 Regulatory Challenges Facing IVD Companies Today (MDDI)
  • FDA Panel to Review Rejection of FzioMed's Oxiplex (FDA)
  • Device makers pay high-volume spine surgeons consulting, design fees (CBS)
  • Court Rules Against Stryker in Failure to Warn Pain Pump Case (Scout)
  • Perforations, deaths temporarily derail St. Jude's E.U. Nanostim study (Mass Device)
  • Baxter lands FDA nod for next-gen Sigma Spectrum infusion pump (Mass Device)
  • Baxter Recalls Abacus TPN Calculation Software Due to Faulty Calculations (FDA)
  • How to Effectively Use FDA's Presubmission Process (MDDI)
  • Medtronic-backed AcuFocus wins FDA panel date for Kamra inlay (Mass Device)
  • Abbott's diagnostic shows it can detect infections in hours in RADICAL trial (MedCity News)
  • GE's new cybersecurity buy includes medical devices (Mass Device)

US: Dietary Supplements

  • FDA Issues Draft Guidance Regarding Food Allergen Labeling Exemption Petitions and Notifications (FDA Law Blog)

US: Assorted And Government

  • PCAST proposals may fit Capitol Hill 'cures' goals (SCRIP-$)
  • How FDA Made Red M&M's Disappear for a Decade (Priceonomics)
  • FDA Hiring New Director for its Office of Technology and Delivery (FDA)
  • FDA Hiring New Director of Business and Customer Service (FDA)

Europe

  • Proactively managing the risk of marketed drugs: experience with the EMA Pharmacovigilance Risk Assessment Committee (Nature)
  • Scottish Medicines Consortium recommends three drugs but rejects Remicade  (SCRIP-$)
  • EDMA has solution to companion Dx but EMA remains closed book (Clinica-$)
  • Elixir Medical Receives CE Mark Approval for the Breakthrough Fully Bioresorbable DESolve 100 Novolimus Eluting Coronary Scaffold System (Press)

India

  • Health ministry appoints Dr Jagashetty as national advisor (drugs control) & project in-charge for CDSCO schemes (PharmaBiz)

Japan & China

  • Japanese officials: Novartis failed to report side effects of leukemia drug (Fierce)
  • CFDA Says Regulatory Reform Needs Market Push (PharmAsia-$)

Other International

  • Australian Watchdog Publishes Audit of TGA (PSnews)
  • Journal: Industry, Not Health Canda, Behind Access Delays (Press) (CBC)
  • Australia Opens Consultation on IMDRF Software Proposal (TGA)
  • Canada regulators stop production at Biolyse Pharma in Ontario (Fierce)
  • Peer Pressure: Vital To Global Drug Quality? (Pharmaceutical Online)

General Regulatory And Interesting Articles

  • The best illustration you'll see that correlation doesn't equal causation (Vox)
  • What's Hidden Inside Fake Medicines (Safe Medicines)
  • Parasitic Worms Wiggle Into Modern Medicine (Scientific American)

Regulatory Reconnaissance #317 - 13 May 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.


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