Regulatory Focus™ > News Articles > Regulatory Recon: Health Insurers Want Reforms to FDA's 510(k) Pathway (17 April 2015)

Regulatory Recon: Health Insurers Want Reforms to FDA's 510(k) Pathway (17 April 2015)

Posted 17 April 2015 | By Alexander Gaffney, RAC

Regulatory Recon: Health Insurers Want Reforms to FDA's 510(k) Pathway (17 April 2015)

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

In Focus: US

  • Health Insurers Call for Stronger Rules on Medical Devices (WSJ-$) (Fierce)
  • FDA and CMS Form Task Force on LDT Quality Requirements (FDA) (Gray Sheet-$)
  • FDA Greenlights First Copaxone Generic (MedPage Today) (SCRIP-$) (Reuters) (Pharmalot) (Pink Sheet-$)
  • FDA's Releases White Paper on New Pharmaceutical Quality Approach (FDA)
  • Breakthrough barriers: Seeking fast track review means betting on data says Roche (In-Pharma)
  • Warning and NOV Letter Summary – 1st Quarter 2015 (Eye on FDA)
  • PhRMA CEO Castellani announces retirement (ModernHealthcare) (PhRMA)

In Focus: International

  • Scientific advice leads to stronger applications from industry (EMA) (Nature)
  • German regulator puts UniQure gene therapy appraisal on hold (Reuters) (SCRIP-$)
  • Europe’s baby meds contain potentially harmful additives (Reuters)
  • TTIP must not jeopardize EU safeguards, say MEPs (SCRIP-$)
  • India amends track and trace plans for pharma exports (SecuringIndustry)
  • China's big pharma companies get thumbs-up from Moody's on reform push (Fierce)
  • EFPIA Welcomes WHO Statement on Clinical Trials Data Disclosure (EFPIA)

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US: Pharmaceuticals and Biotechnology

  • FDA Greenlights First Copaxone Generic (MedPage Today) (SCRIP-$) (Reuters) (Pharmalot) (Pink Sheet-$)
  • FDA's Releases White Paper on New Pharmaceutical Quality Approach (FDA)
  • Breakthrough barriers: Seeking fast track review means betting on data says Roche (In-Pharma)
  • FDA to Hold Workshop on Pharmacoepidemiology and Relying on Healthcare Databases (FDA)
  • GPhA launches Biosimilars Council (Press) (Pink Sheet-$)
  • Joint Workshop on Drug Transporters in Absorption, Distribution, Metabolism, and Excretion: From the Bench to the Bedside (FDA)
  • FDA Pressed To Clarify Purity Standard On Injectables (Law 360-$)
  • How Marketing And Media Muddled The Truth About The Heart Drug Vytorin (Forbes)
  • U.S. Marshals seize unapproved drugs from Florida distributor (FDA)
  • Pliva's Win In 5th Circ. Is A Blueprint To Beat 'Off-Label' Suits (Law 360-$)
  • Risperdal Lawsuit Filed against Federal Government (Press)
  • FDA Urges Improving Characterization, Manufacturing Control, and Potency Assay Design for Cell and Gene Therapies (IPQ-$)
  • Olysio Label Now Includes New Warnings (MPR)

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

  • Athersys stroke treatment fails study, shares slide (Reuters)
  • AZ's Selumetinib granted Orphan Drug Designation by US FDA for treatment of uveal melanoma (Press)
  • MedDay announces its pivotal Phase III study of MD1003 in patients with Progressive Multiple Sclerosis meets primary endpoint (Press)
  • Oncolytics Biotech Inc. Announces Receipt of Orphan Drug Designation from the U.S. FDA for Malignant Gliomas (Press)
  • AstraZeneca lung cancer drug delays disease by more than a year (Reuters) (Press)
  • Transgene SA: Agreement with FDA Announced for Special Protocol Assessment for Upcoming Phase 3 Pexa-Vec Trial in Advanced Liver Cancer (Press)
  • SillaJen Announces Agreement with the FDA for a Special Protocol Assessment for Upcoming Phase 3 Pexa-Vec Trial in Advanced Liver Cancer (Press)

US: Pharmaceuticals and Biotechnology: General

  • PhRMA CEO Castellani announces retirement (ModernHealthcare) (PhRMA)
  • FTC To Dive Deep In Pay-To-Delay Analysis, Brill Says (Law 360-$)
  • Another House Hearing to Look Into Opioid Abuse (House)

US: Medical Devices

  • Health Insurers Call for Stronger Rules on Medical Devices (WSJ-$) (Fierce)
  • FDA and CMS Form Task Force on LDT Quality Requirements (FDA) (Gray Sheet-$)
  • FDA Asks Experts For On Aneurysm Flow Diverter Clinical Trials (Gray Sheet-$)
  • Global Trials Show Addition of Medtronic’s Solitaire Device Stent Thrombectomy Procedure in Treatment of Acute Ischemic Stroke Improves Neurological Outcomes (Press)
  • Conventus Orthopaedics wins FDA clearance for shoulder fracture fixation device (Mass Device)
  • Focus Diagnostics gets FDA nod for rapid strep test (Fierce)
  • Abbot Receives FDA Clearance for New Blood Glucose Meter (Press)

US: Assorted And Government

  • Warning and NOV Letter Summary – 1st Quarter 2015 (Eye on FDA)
  • Trade Promotion Authority Bill Prioritizes Reimbursement Transparency (Gray Sheet-$) (White House)
  • Center for Inquiry Invited to Testify Against Homeopathy at FDA Public Hearings (CFI)
  • FDA Weekly Enforcement Report (FDA)

Upcoming Meetings and Events

Europe

  • Scientific advice leads to stronger applications from industry (EMA) (Nature)
  • German regulator puts UniQure gene therapy appraisal on hold (Reuters) (SCRIP-$)
  • Europe’s baby meds contain potentially harmful additives (Reuters)
  • TTIP must not jeopardize EU safeguards, say MEPs (SCRIP-$)
  • French health bill OKd with new provision on early HTA advice (SCRIP-$)
  • New EU Directives on Tissues and Cells boost safety, but we can't stop there (EC)
  • Cepheid Qualitative HIV-1 Test Receives CE Mark (GenomeWeb)
  • Startup gets CE mark for diabetic retinopathy screening software, FDA up next (Fierce)

India

Japan

  • Baxter Submits Application to Japan's MHLW for Approval of BAX 855, Extended Half-Life Recombinant FVIII Based on ADVATE for Hemophilia A (Press)

China

  • China's big pharma companies get thumbs-up from Moody's on reform push (Fierce)

Other International

  • One-stop regulatory shop: country-by-country global regulatory update for key jurisdictions (Clinica-$)
  • UN restrictions on narcotic ketamine would impede veterinary practices, trade group argues (Fierce)

Clinical Trials

  • EFPIA Welcomes WHO Statement on Clinical Trials Data Disclosure (EFPIA)

General Regulatory And Interesting Articles

  • Common heartburn drugs linked to kidney failure in the elderly (Reuters)
  • Clues to How an Electric Treatment for Parkinson’s Works (NYTimes)
  • 2 things you should do asap when starting a medical device project (MedCityNews)
  • If SpaceX CEO Musk was Biotech CEO, Rocket's 'Landing' Big Win (The Street)

Regulatory Reconnaissance #538 – 17 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.


Categories: Recon, Regulatory News

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