Regulatory Focus™ > News Articles > Regulatory Reconnaissance: FDA's 2014 Regulatory Plans Revealed (7 January 2013)

Regulatory Reconnaissance: FDA's 2014 Regulatory Plans Revealed (7 January 2013)

Posted 07 January 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

  • DHHS & FDA Releases Their Semiannual Regulatory Agenda (DHHS)
  • CDISC Announces Study Data Set - XML Draft Standard Available for Public Review (CDISC)
  • PhRMA Wants Off-Label Use To Help Drive Expanded Indications (Pink Sheet-$)
  • The Federal Circuit is Slated to Consider an Appeal of the First BPCIA Biosimilars "Patent Dance" Decision (FDA Law Blog)
  • Topera Announces 510(k) Clearance of its Third Generation 3D Mapping System (Press) (Fierce) (Mass Device)
  • FDA Guidelines for Medical Device Cybersecurity - What Do They Mean to You? (Medical Design)

In Focus: International

  • Abraxane Plus gemcitabine Receives European Marketing Authorization for First-Line Treatment of Patients with Metastatic Pancreatic Cancer (Press) (RTT News)
  • China's Regional FDAs To Approve Anesthetic, Type I Psychiatric Drugs (PharmAsia-$)
  • India: DCGI to take up matter of barcoding for primary packaging with Commerce Min (Pharmabiz)

US: Pharmaceuticals/Biotechnology

  • PhRMA Wants Off-Label Use To Help Drive Expanded Indications (Pink Sheet-$)
  • Three biopharma companies poised for product OKs in 2014: analyst (Market Watch)
  • The Federal Circuit is Slated to Consider an Appeal of the First BPCIA Biosimilars "Patent Dance" Decision (FDA Law Blog)
  • Secrecy protects only laggards: why the FDA should disclose which drug companies volunteer for its "judicious use" antibiotics livestock policy (CPR)
  • PCPC and ACI continue defense of antibac soap safety following FDA ruling (Cosmetics Design)
  • Market builders: Complex, but rewarding work of rare disease R&D (SCRIP-$)
  • Five firms create new portal for patient-level data requests (SCRIP-$)
  • Duchenne Muscular Dystrophy Illustrates Potential Utility of Innovative Benefit-Risk Assessments in Regulatory Review (PhRMA)

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

  • Navidea wants the FDA to approve a wider use of its injectable cancer imaging agent (Fierce)
  • Aeterna Zentaris' macimorelin under FDA review (SCRIP-$) (BioCentury)
  • Orexigen Announces June 10, 2014 PDUFA Action Date for Contrave (Press)
  • Shield ready to file after 'strongly' positive PhIII with oral anemia drug (SCRIP-$)
  • Alitair Receives Orphan Drug Designation for Erdosteine in Bronchiectasis (Press)

US: Pharmaceuticals and Biotechnology: General

  • Medicare Up, Everyone Else Down: The Latest U.S. Drug Spending Data (Drug Channels)
  • Calif. college students to get imported meningitis vaccine (NBC)
  • New healthcare regs target Medicare Part D Fraud (The Hill)
  • CMS looks to cut protected drugs under Part D (BioCentury) (FR)

US: Medical Devices

  • Medtronic gives it another go with atrial fibrillation device (Fierce)
  • Topera, Inc. Announces 510(k) Clearance of its Third Generation 3D Mapping System (Press) (Fierce) (Mass Device)
  • FDA Guidelines for Medical Device Cybersecurity - What Do They Mean to You? (Medical Design)
  • Diabetes: FDA puts highest risk label on Abbott's blood glucose test strip recall (Mass Device) (FDA)
  • GE Recalls Device Attachment Due to Small Holes (FDA)
  • Smiths Medical lands 510(k) for pain pump (Mass Device)
  • Sapheon Submits Second Module of PMA Application for VenaSeal Sapheon Closure System (Press)
  • FDA Reclassifies ECP Devices for Refractory Angina as Class II (Press)

US: Dietary Supplements

  • FTC Hits Maker Of Diet Supplement Products Over Ad Claims (Law 360-$)
  • Most vitamin studies are flawed by poor methodology, say Linus Pauling researchers (Nutra Ingredients)

US: Assorted And Government

  • DHHS & FDA Releases Their Semiannual Regulatory Agenda (DHHS)
  • CDISC Announces Study Data Set - XML Draft Standard Available for Public Review (CDISC)

Upcoming Meetings And Events

  • 10 January 2013: National Biodefense Science Board Meeting (DHHS)
  • 28-29 January 2013: Workshop - Strategies to Address Hemolytic Complications of Immune Globulin Infusions (FDA)
  • 2014 FDA OAGS Small Business Outreach Vendor Fair (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • Abraxane Plus gemcitabine Receives European Marketing Authorization for First-Line Treatment of Patients with Metastatic Pancreatic Cancer (Press) (RTT News)
  • Cell Medica Announces Orphan Drug Designation in the European Union for Cytovir ADV (Press)
  • NPS Pharma Gets Orphan Designation in EU (Press)

Asia

  • China's Regional FDAs To Approve Anesthetic, Type I Psychiatric Drugs (PharmAsia-$)
  • India: DCGI to take up matter of barcoding for primary packaging with Commerce Min (Pharmabiz)

General Regulatory And Interesting Articles

Regulatory Reconnaissance #230 - 7 January 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.


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