Regulatory Focus™ > News Articles > Regulatory Recon: Group Calls on FDA to Crack Down on Diabetes Drug Marketing (1 April 2015)

Regulatory Recon: Group Calls on FDA to Crack Down on Diabetes Drug Marketing (1 April 2015)

Posted 01 April 2015 | By Alexander Gaffney, RAC

Regulatory Recon: Group Calls on FDA to Crack Down on Diabetes Drug Marketing (1 April 2015)

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

In Focus: US

  • Public Citizen: FDA Needs to Crack Down on Diabetes Drug Marketing (PC) (Letter)
  • FDA Issues Guidance for Target Animal Safety Data Presentation (FDA) (Guidance) (FR)
  • Here Comes the Flood – Amendments are the Next Mountain to Climb for OGD (Lachman)
  • Troubled DMD Company Sarepta Fires CEO Over Regulatory Issues (Press) (BioFlash) (The Street) (Xconomy) (Forbes)
  • Celltrion Seeks FDA Approval for Biosimilar Remsima (WSJ-$)
  • Feds Promote Test Beds for Wireless Medical Devices (HealthDataManagement)
  • Avedro Eye Treatment’s Second Rejection Driven By Device, Not Drug (Gray Sheet-$) (Press) (SCRIP-$)
  • Can Anything Kill the Deadly Bacteria on Endoscopes? (Bloomberg)
  • Tackling Administrative Waste: The Promises Of Data Science For The FDA (Forbes)
  • FDA Gets Poor Grades When it Comes to Allowing Scientists to Speak Freely (Pharmalot)

In Focus: International

  • European project for flexible drug approvals moves up a gear (Reuters)
  • EMA: TTIP and inspection databases a way of improving global manufacturing standards (BioPharmaReporter)
  • Europe bans Chinese API maker over contamination issues (Fierce)
  • EMA pledges to review PIPs quickly for Ebola treatments (SCRIP RA-$)
  • China manufacturing requirements pose hurdle for global biosimilars players (BioCentury-$)
  • China puts stem-cell clinical trial regulation in play with draft for comment (Fierce)
  • Hospira's Inflectra becomes Canada's first biosimilar (SCRIP-$)

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US: Pharmaceuticals and Biotechnology

  • Public Citizen: FDA Needs to Crack Down on Diabetes Drug Marketing (PC) (Letter)
  • FDA Issues Guidance for Target Animal Safety Data Presentation (FDA) (Guidance) (FR)
  • Here Comes the Flood – Amendments are the Next Mountain to Climb for OGD (Lachman)
  • FDA’s Streamlined Review Pilot Takes Flight; Second Oncology sNDA Through Process (RPM Report-$)
  • Development, Commercialization of Antibacterial Drugs to Speed Up (Press)
  • Pew Summary of President’s Plan to Combat Antibiotic-Resistant Bacteria (Pew)
  • Troubled DMD Company Sarepta Fires CEO Over Regulatory Issues (Press) (BioFlash) (The Street) (Xconomy) (Forbes)
  • Why we should care that an FDA panelist forgot to disclose conflicts of interest (BioFlash)
  • Teva Announces FDA Approval of ProAir RespiClick (Press)
  • New Funding Opportunity Announcement for Minor Use/Minor Species (MUMS) Development of Drugs (FDA)
  • Oregon Right to Try Bill Advances in House (Press)
  • Fed. Circ. Revives Generic Benicar Exclusivity Challenge (Law 360-$)
  • HDMA Updates DSCSA Q&A (RxTrace)

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

  • Celltrion Seeks FDA Approval for Biosimilar Remsima (WSJ-$)
  • Idera Announces FDA Orphan Drug Designation for IMO-8400 for the Treatment of Diffuse Large B-Cell Lymphoma (Press)

US: Pharmaceuticals and Biotechnology: General

  • Millions To Be Made On...Generic Drugs? (Forbes)
  • Formulary Policy For Biosimilars In Part D Clarified In CMS Guidance (Pink Sheet-$) (BioCentury)

US: Medical Devices

  • Feds Promote Test Beds for Wireless Medical Devices (HealthDataManagement)
  • White House calls for advancing rapid diagnostics to combat drug-resistant bacteria (Fierce)
  • Avedro Eye Treatment’s Second Rejection Driven By Device, Not Drug (Gray Sheet-$) (Press) (SCRIP-$)
  • FDA hosts medical device reprocessing webinar (Mass Device)
  • Can Anything Kill the Deadly Bacteria on Endoscopes? (Bloomberg)
  • FDA: Don't Wait On 'Case For Quality'; 'Build Bridges' To Better-Than-Baseline Practices Now (Gray Sheet-$)
  • FDA Investigators Will Still Be Well Rounded Despite Being In Commodity-Based Silos, MacFarland Asserts (Gray Sheet-$)
  • Wearables the rage but are they medical devices? (Eisner)
  • FDA OKs SynCardia trial for bridge-to-transplant indication (MassDevice)

US: Dietary Supplements

  • Office of Dietary Supplements VDSP Commutability Study 2 (NIH)

US: Assorted And Government

  • Tackling Administrative Waste: The Promises Of Data Science For The FDA (Forbes)
  • FDA Gets Poor Grades When it Comes to Allowing Scientists to Speak Freely (Pharmalot)
  • NIH's Collins on Changing the Future of Medicine (Medscape)
  • Public health reporters say federal agencies are restricting access and information, limiting their ability to cover crucial health issues (Nieman)

Upcoming Meetings and Events

Ebola Outbreak

  • EMA pledges to review PIPs quickly for Ebola treatments (SCRIP RA-$)

Europe

  • European project for flexible drug approvals moves up a gear (Reuters)
  • EMA: TTIP and inspection databases a way of improving global manufacturing standards (BioPharmaReporter)
  • Europe bans Chinese API maker over contamination issues (Fierce)
  • Guideline on clinical investigation of medicinal products for the treatment of Multiple Sclerosis (EMA)
  • EMA's strategies to meet the challenges of Alzheimer disease (Nature-$)
  • EC Approves Aptalis Pharma’s Levofloxacin, Quinsair, for Cystic Fibrosis Infections (EC)
  • EC Approves Merck’s Dutrebis for HIV (EC)
  • UK lags behind peers in access to new meds (SCRIP-$)
  • Certificates of Free Sale for medical devices: registration and use (MHRA)
  • Baxter Completes CE Mark Approval for HOMECHOICE CLARIA Automated Peritoneal Dialysis System with SHARESOURCE (Press)

India

  • DCGI to link PSURs with pharmacovigilance programme for better tapping of ADRs (PharmaBiz)
  • Exporters demand exemption of barcodes on mono-cartons on export consignment of pharmaceuticals (PharmaBiz)
  • Industry welcomes Centre's move to set up MvPI, but cautions against mimicking PvPI (PharmaBiz)

China

  • China manufacturing requirements pose hurdle for global biosimilars players (BioCentury-$)
  • China puts stem-cell clinical trial regulation in play with draft for comment (Fierce)

Canada

  • Hospira's Inflectra becomes Canada's first biosimilar (SCRIP-$)

Australia

  • Australia's reimbursement cost battle hits cancer drug access (Fierce)

Other International

  • Regulatory moves afoot in Africa to find solutions and grow markets (Clinica-$)

Clinical Trials

General Regulatory And Interesting Articles

  • New security report raises possibility of ‘medical zero day’ exploits (VentureBeat)
  • New cancer drugs 'vastly overestimated', says contrarian analyst (Reuters)
  • Opioid Misuse at 25 Percent, Addiction at 10 Percent (Press)
  • Safe but inadequate: Tylenol flunks back pain test (Today)
  • Drug metabolism: manipulating the microbiome (PharmJournal)
  • Crusted Ring Around NyQuil Bottle Top Coming Along Nicely (The Onion – Satire)

Regulatory Reconnaissance #526 – 1 April 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 @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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