Regulatory Focus™ > News Articles > Regulatory Recon: House, Senate Appropriators Make Demands of FDA (30 May 2014)

Regulatory Recon: House, Senate Appropriators Make Demands of FDA (30 May 2014)

Posted 30 May 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: House, Senate Appropriators Make Demands of FDA (30 May 2014)

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

  • As Senate and House Lawmakers Slog Through FDA Appropriations Bills, FDA’s To-Do List Grows (FDA Law Blog) (Report) (BioCentury) (BioCentury) (Pink Sheet-$) (SCRIP-$)
  • Bills would press FDA on sunscreen (The Hill)
  • India's Zydus Cadila recalls over 10,000 bottles of allergy drug in U.S (Reuters)
  • House E&C subcommittee advances scheduling bill (BioCentury) (E&C) (Pitt)
  • FDA allows marketing of first non-invasive test to help in identifying cause of certain kidney disease (FDA)
  • OIG to Review Medical Device Security (GovInfoSec)

In Focus: International

US: Pharmaceuticals/Biotechnology

  • As Senate and House Lawmakers Slog Through FDA Appropriations Bills, FDA’s To-Do List Grows (FDA Law Blog) (Report) (BioCentury) (BioCentury) (Pink Sheet-$) (SCRIP-$)
  • Bills would press FDA on sunscreen (The Hill)
  • India's Zydus Cadila recalls over 10,000 bottles of allergy drug in U.S (Reuters)
  • House E&C subcommittee advances scheduling bill (BioCentury) (E&C) (Pitt)
  • BPTF Warns FDA on Reduced API Manufacturer Inspections (PharmTech)
  • FDA Researchers Find Way to Speed up Toxicological Screenings Using Zebrafish Embryos (Applied Toxicology)
  • FDA Researchers Find Association Between Malaria Drug Quinine and Thrombotic Microangiopathy (TMA) and immune Thrombocytopenic Purpura (ITP) (PubMed)
  • FDA’s Final Guidance on Expedited Drug Approvals: Fueling Innovation and Helping Patients (FDA)
  • Fears Of Too Many OTC Choices Should Not Restrict Switches, Stakeholders Say (Tan Sheet-$)

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

  • Newron submits safinamide NDA (BioCentury) (Pharma Times)
  • Genzyme’s Lemtrada Resubmission Accepted for Review by FDA (Press) (Fierce)
  • Sigma Tau Aims For First FDA Approval Of Live Biotherapeutic (Pink Sheet-$)
  • Safinamide New Drug Application (NDA) Submitted to FDA (Press)
  • Angiochem’s ANG1005 Received Fast Track and Orphan Drug Designation from FDA for the Treatment of Glioblastoma Multiforme (Press)

US: Pharmaceuticals and Biotechnology: General

  • KV Pharmaceutical Now Named "Lumara Health," Goes Private (MM&M)
  • What's Old Is New Again--A Prescription for Drug Repurposing (Fierce)
  • PhRMA chief tears into insurers over Sovaldi cost moans (Pharma Times) (Press)
  • Expensive Drugs Forcing Cancer Doctors to Weigh Price (Bloomberg)

US: Medical Devices

  • FDA allows marketing of first non-invasive test to help in identifying cause of certain kidney disease (FDA)
  • OIG to Review Medical Device Security (GovInfoSec)
  • Can Your App Avoid FDA Regulation? 4 Questions to Ask (MDDI)
  • Senators push for Medicare to cover lung cancer test (The Hill)
  • FDA clears nonsurgical treatment for male urinary and fecal incontinence (Fierce)
  • Researchers Talk About the Evaluation of Biomarkers (PubMed)
  • FDA says pancreatic stents are lower-risk at Xlumena's request (Mass Device)
  • FDA approves 1st non-drug treatment for Restless Leg Syndrome (Mass Device) (Press)

US: Assorted And Government

  • Biotech Co. Hit With Class Action Over Medical Food (Law 360-$)
  • Enforcement Report - Week of May 28, 2014 (FDA)
  • The House just voted to protect medical marijuana patients from federal interference (Vox) (HuffPo)
  • Connecticut Transparency Law: APRN Payment Reprorting Date Pushed Back to July 1, 2015 (Policy and Medicine)
  • DOJ Announces Significant Policy Shift on Electronic Recordings of Statements; Will Other Agencies Follow? (FDA Law Blog)
  • Missouri Official Proposes Execution Drug Lab (AP)

Europe

  • BMJ slams EMA ‘U-turn’ (Pharmafile) (BioCentury)
  • Will Europe Remain Medtech's Innovation Destination? (MDDI)
  • EC approves Bayer’s Nexavar for differentiated thyroid cancer (Pharma Letter-$) (Press) (Pharma Times)
  • Draft guide attempts to ease pharma worries over EMA-HTA advice (SCRIP-$)
  • Janssen's Stelara Rejection At NICE Puts Innovation In The Spotlight (Pink Sheet-$)
  • EU industry calls for specialized, not special, notified bodies (Clinica-$)

India

  • GMP Woes: India’s Process Versus Quality Debate Set For A Global Spin? (PharmAsia-$)
  • Pharma dept to bat for revival of bulk drug industry (India Times)
  • Health & drug to remain under administrative control of two ministries despite streamlining process by Modi govt (PharmaBiz)
  • Concern That India's Attempts to Further Cut Drug Prices Will Impact Drug Quality (India Times)

Japan & China

  • China enhances drug safety for children (Shanghai Daily)
  • Bayer Global Regulatory Affairs Head Joseph Scheeren On Multi-Regional Clinical Trials In China (PharmAsia-$)
  • Astellas and UMN Announce Submission of Application for Marketing Approval of Recombinant Influenza HA Vaccine ASP7374 in Japan (Press)
  • US supplements economy loses $8bn due to Great Wall of Regulations (Nutra Ingredients) (NI-USA)

Canada

  • Guidance Document: Biopharmaceutics Classification System Based Biowaiver (Health Canada)

General Regulatory And Interesting Articles

  • Military Funds Brain-Computer Interfaces to Control Feelings (MIT Tech Review)

Regulatory Reconnaissance #328 – 30 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.

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