Regulatory Focus™ > News Articles > Regulatory Reconnaissance (1 October 2013)

Regulatory Reconnaissance (1 October 2013)

Posted 01 October 2013 | By Alexander Gaffney, RAC 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. We're coming to you from Boston this week for the 2013 RAPS Regulatory Convergence-our annual gathering of thousands of regulatory professionals. If you see us walking around, come say "Hello"! We'd love to meet you. In the meantime, got any tips or gripes? Shoot us an email at news@raps.org.

In Focus: US

  • US Government is Officially Shut Down Per the Office of Management and Budget (WaPo)
  • Percent of FDA Staff Currently Furloughed: 45%
  • FDA Releases Long-Awaited Final IDE Guidance for Early Feasibility Device Studies (FDA) (Gray Sheet) (FR)
  • FDA Publishes ANDA Submission Guidance (BioPharm Intl) (FR)
  • Legislator: OMB Improperly Sequestering FDA User Fees (BioCentury TV)
  • Quality Metric Requirements Coming Soon for Drugmakers (FDA News-$)
  • FDA Bestows Grant For Global Workforce Program (Food Product Design)
  • User-Friendly Federal Register Site May go Offline During Shutdown (FR)

In Focus: International

  • Device makers fight as E.U. lawmakers back heavier regulation (Mass Device) (MedPage Today)
  • New rules will force EU medtech notified bodies to up their game (Clinica-$)
  • EMA Releases Updated Draft Guideline on Development of HIV Products (EMA) (EMA)
  • EUnetHTA Weighs in on EMA Clinical Trials Data Transparency Proposal (EUnetHTA)
  • Indian Pharma companies see need for tighter compliance procedures (Business Standard)
  • Indian Supreme Court stays DCGI nod to 162 clinical trial applications (India Times)
  • Oncologists call for industry-led global fund to fight cancer (Reuters)

Comments? Suggestions? Email me at news@raps.org.

US: Pharmaceuticals/Biotechnology

  • FDA Publishes ANDA Submission Guidance (BioPharm Intl) (FR)
  • Legislator: OMB Improperly Sequestering FDA User Fees (BioCentury TV)
  • Quality Metric Requirements Coming Soon for Drugmakers (FDA News-$)
  • Roche's Perjeta becomes first FDA-approved pre-surgical breast cancer drug (CBS) (MedPage Today) (SCRIP-$) (FDA) (Fierce) (Reuters) (BioCentury) (Roche) (Pharma Letter-$) (PMLive)
  • Third US approval for UCB's Cimzia (Pharma Times) (Press) (SCRIP-$)
  • FDA approves Lundbeck's antidepressant Brintellix (Reuters) (Pharma Times) (FDA) (Fierce) (SCRIP-$) (Press)
  • Why Robust Biopharmaceutical Innovation Is Increasingly Dependent On a Functional Regulatory Path For Quality Biosimilars (Forbes)
  • Vertex seeks to expand cystic fibrosis patient pool with sNDA filing (BioFlash) (Vertex) (BioCentury)
  • AcelRx submits Zalviso NDA (BioCentury)
  • Waiting For The Senate To Act On A Track & Trace Bill, Again (RxTrace) (FDA Law Blog)
  • FDA to host CFS teleconference (BioCentury)
  • How biosimilar battles are brewing over state laws, names and labels (BioCentury-$)
  • In cancer drug battle, both sides appeal to ethics (CNN)
  • FDA Grants Orphan Drug Designation to Omeros' OMS824 for Huntington's Disease (PharmPro)
  • More Ben Venue manufacturing issues will lead to Doxil shortages in October (Outsourcing Pharma)
  • Brown Signs Two Bills To Reduce Rx Misuse, Vetoes Another (CA Healthline)
  • Ariad to reduce initial dose in mid-stage trial of lung cancer drug (BioFlash)
  • US: Pharmaceuticals and Biotechnology: General
  • Eli Lilly Says Disappointed With CMS Decision To Deny Patient Access To Amyvid (RTT) (Reuters) (Fierce)
  • Pharma Working on Sunshine Act Disclosures (MedPage Today)
  • DEA argues there's no right to privacy with prescriptions (Fierce)
  • Prescription drug use among US seniors "has plateaued" (Pharma Times)

US: Medical Devices

  • FDA Releases Long-Awaited Final IDE Guidance for Early Feasibility Device Studies (FDA) (Gray Sheet) (FR)
  • FDA Guidance on Wireless Devices: What You Need To Know (MDDI)
  • Gov't shutdown would hit ONC hard (GovHIT)
  • BioRestorative Engages Consulting Firm to Advance brtxDISC Program Delivery Device through FDA Clearance Process (Press)
  • Xpect Flu A&B Assay Achieves FDA Clearance for Novel Avian Influenza A (H7N9) Analytical Reactivity Label Claims (Press)
  • Class I Recall for Codman's Infusion Pumps and Recall Kits due to Higher-Than programmed Drug Flow Rate (FDA)

US: Assorted And Government

  • US Government is Officially Shut Down Per the Office of Management and Budget (WaPo)
  • Senators call it a night as the government shuts down (The Hill) (MedPage Today)
  • FDA Bestows Grant For Global Workforce Program (Food Product Design)
  • User-Friendly Federal Register Site May go Offline During Shutdown (FR)
  • Agency websites, other technology to go dark during shutdown (Federal News Radio)
  • PEPFAR 3.0: The Easiest Decision for Congress This Week (CGD)
  • How A Tax On Medical Devices United Political Rivals (NPR)
  • False Claims Act: External Auditor Moonlights as Whistle Blower (Policy and Medicine)

Upcoming Meetings And Events

  • 29 Sept. - 2 Oct. 2013: 2013 RAPS Regulatory Convergence (RAPS)
  • 3 October 2013: Congressional Hearing on FDA's Implementation of FDASIA (E&C)
  • 4 October 2013: Joint FDA-EMA Orphan Drug Workship (Details)
  • October 8-9, 2013: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 9-10 October 2013: AAMI/FDA Summit on Healthcare Technology in Nonclinical Settings (AAMI)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • EMA accepts file for AstraZeneca PARP inhibitor (Pharma Times)
  • Device makers fight as E.U. lawmakers back heavier regulation (Mass Device) (MedPage Today)
  • New rules will force EU medtech notified bodies to up their game (Clinica-$)
  • EMA Releases Updated Draft Guideline on Development of HIV Products (EMA) (EMA)
  • EUnetHTA Weighs in on EMA Clinical Trials Data Transparency Proposal (EUnetHTA)
  • Cancer Drugs Fund Extended As Pharma Calls For U.K. HTA Rethink (Pink Sheet-$)
  • NICE sticks by u-turn on Alimera's Iluvien (Pharma Times) (pSivida) (SCRIP-$)
  • Draft paediatric addendum to the note for guidance on the clinical investigation on medicinal products in the treatment of hypertension (EMA)
  • EUnetHTA Adds Co-Chair Position to Represent Views of Patients (EUnetHTA)
  • European Medicines Agency publishes a video explaining the concept of medicines under additional monitoring (EMA)

Asia

  • Indian Pharma companies see need for tighter compliance procedures (Business Standard)
  • Indian Supreme Court stays DCGI nod to 162 clinical trial applications (India Times)
  • Indian Special panel to prepare list of harmful drugs & vaccines in market for banning (PharmaBiz)
  • Japan Panel Says Diovan Ads Possibly Deceptive, Ministry To Probe (PharmAsia-$) (Reuters)
  • Japan's Kissei and JCR link for Aranesp biosimilar (SCRIP-$)

Other International

  • Oncologists call for industry-led global fund to fight cancer (Reuters)
  • Ghana Bans Anti-Malaria Drug Made in India (Med India) (BioSpectrum)
  • 2013 annual report of the Australian Orthopaedic Association's National Joint Replacement Registry (TGA)
  • Bumpy road won't deter Sanofi's push into emerging markets (Reuters) (India Times)

General Regulatory And Interesting Articles

  • Hiring and career development for RA/QA professionals (Mass Device)

Regulatory Reconnaissance #168 - 1 October 2013

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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