Regulatory Focus™ > News Articles > Regulatory Recon: FDA Poised for Funding Boost in 'Cures' Bill (21 May 2015)

Regulatory Recon: FDA Poised for Funding Boost in 'Cures' Bill (21 May 2015)

Posted 21 May 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: FDA Poised for Funding Boost in 'Cures' Bill (21 May 2015)

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

In Focus: US

  • 21st Century Cures Act Markup to Reconvene Today (The Hill)  (ModernHealthcare) (SCRIP-$) (Politico)
  • PDUFA Could Be Improved By More FDA Discipline Review Letters, Firms Say (Pink Sheet-$)
  • FDA Cautions About Dose Confusion and Medication Errors With Zerbaxa (ceftolozane and tazobactam) (FDA)
  • FDA AdComm to Review Eli Lilly's Necitumumab for NSCLC (FDA)
  • MelaFind Device Recalled Due to Unapproved Software Components (FDA)
  • HBO report links Hatch to military deaths associated with DMAA via his sponsorship of DHSEA (NI-USA) (NewHope360)

In Focus: International

  • New EMA Draft Guideline on the Development of Gene Therapies (EMA) (EMA)
  • EMA Exploring new ways to fight antimicrobial resistance (EMA)
  • Changes to EU guidelines on device clinical investigation on the agenda (Clinica-$)
  • World's Most Expensive Medicine: Is it Worth the Price? (Bloomberg)
  • Eisai Signs on to Industry Clinical Trial Transparency Initiative (Eisai)

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US: Pharmaceuticals and Biotechnology

  • PDUFA Could Be Improved By More FDA Discipline Review Letters, Firms Say (Pink Sheet-$)
  • FDA Cautions About Dose Confusion and Medication Errors With Zerbaxa (ceftolozane and tazobactam) (FDA)
  • FDA AdComm to Review Eli Lilly's Necitumumab for NSCLC (FDA)
  • Recall for Generic Asthma Drug Manufactured by Cipla (India Times)
  • FDA Helps to Break up Pharmaceutical Fraud Ring in Florida (Local10)
  • Sunscreen Innovation Act Illuminates ‘Good Things’ For OTC Monograph Reform (Tan Sheet-$)
  • The Problems With FDA's New Blood Donation Policy (The New Republic)
  • FDA Renews Charter of Medical Imaging Drugs Advisory Committee (FDA)
  • Glenmark Gets Tentative US Regulatory Nod to Sell Seizure Treatment Drug (NDTV)

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

  • Tris Pharma Announces the FDA Acceptance of NDA for Dyanavel XR (Press)
  • Regeneron's arthritis drug aces Phase III with the FDA in sight (Fierce) (Press)
  • Genocea's herpes vaccine hits the mark in Phase II (Fierce) (BioCentury)
  • Wockhardt gets QIDP status for pneumonia drug from USFDA (Business Standard)
  • FDA sparks AVEO investors' hopes for tivozanib in RCC (SCRIP-$)

US: Pharmaceuticals and Biotechnology: General

  • DEA to Schedule Acetyl Fentanyl Into Schedule I (DEA)
  • DEA announces four-state crackdown on illegal pill distribution (Reuters) (NYTimes)
  • Maine Bill Aims To Make Abuse-Deterrent Painkillers More Affordable (NPR)

US: Medical Devices

  • MelaFind Device Recalled Due to Unapproved Software Components (FDA)
  • ECG monitor app helps users find heart rhythm issues (ModernHealthcare)

US: Dietary Supplements

  • HBO report links Hatch to military deaths associated with DMAA via his sponsorship of DHSEA (NI-USA) (NewHope360)

US: Assorted And Government

  • 21st Century Cures Act Markup to Reconvene Today (The Hill)  (ModernHealthcare) (SCRIP-$) (Politico)
  • FDA's Weekly Enforcement Report (FDA)
  • Beyond Moral Outrage — Weighing the Trade-Offs of COI Regulation (NEJM)
  • New group pushes to overhaul organ donations (The Hill)

Upcoming Meetings and Events

Ebola Outbreak

Europe

  • New EMA Draft Guideline on the Development of Gene Therapies (EMA) (EMA)
  • EMA Exploring new ways to fight antimicrobial resistance (EMA)
  • Changes to EU guidelines on device clinical investigation on the agenda (Clinica-$)
  • World's Most Expensive Medicine: Is it Worth the Price? (Bloomberg)
  • MHRA issues medical safety alert for RelonChem Ltd / Kent Pharmaceuticals Tramadol 50mg capsules (MHRA)
  • Baxter BioScience Files for European Approval of Investigational 20% Subcutaneous Immune Globulin Treatment for Primary Immunodeficiency (Press)
  • Public consultation on the position paper on how to decide on the appropriate study design for primary research arising from HTA (EUnetHTA)

India

Clinical Trials

  • Eisai Signs on to Industry Clinical Trial Transparency Initiative (Eisai)
  • Trial-Results Reporting and Academic Medical Centers (NEJM)
  • African Americans prone to display negative perceptions of cancer-related clinical trials (MNT)

General Regulatory And Interesting Articles

  • A unified authentication system is needed to combat the massive trade in counterfeit medicines (PharmJournal)
  • Pharmacogenomics project seeks to provide personalised drug safety profiles (PharmaJournal)

Regulatory Reconnaissance #562 – 61 May 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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