Regulatory Focus™ > News Articles > Regulatory Reconnaissance (12 December 2013)

Regulatory Reconnaissance (12 December 2013)

Posted 12 December 2013 | 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

  • More Me-Too Drugs Please, FDA's Jenkins Asks Industry (Pink Sheet-$)
  • CDER New Drug Review: 2013 Update (FDA)
  • What are CDER's Priorities for 2013-14? (FDA)
  • Hamburg: mHealth requires scientific evidence (Fierce)
  • Your Guide to 2013's Must-Read FDA Documents from CDRH (MDDI)
  • Reps. to introduce bill for antibiotic pathway, breakpoints (BioCentury)
  • New Budget Deal Would Eliminate Sequestration of User Fees (BioCentury)

In Focus: International

  • EMA Unveils New Pharmacovigilance Practice Guidelines (EMA) (EMA) (EMA) (EMA)
  • French give go-ahead to biosimilar substitution (SCRIP-$)
  • UK ortho industry moves to strengthen EU post-market surveillance (Clinica-$)
  • Device supervision, reprocessing are key issues in new EU regs as Greeks commit to challenge (Clinica-$)
  • Ireland resists tougher EU device regulations (Fierce)

US: Pharmaceuticals/Biotechnology

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

  • Confident Orexigen re-files Contrave NDA, expects mid-2014 decision (SCRIP-$) (AP)
  • Sprout appealing FDA complete response for flibanserin (BioCentury) (Fierce)
  • FDA to again review QRxPharma's MoxDuo IR (BioCentury)
  • Avastin Misses Mark Again in Breast Cancer (MedPage Today)

US: Pharmaceuticals and Biotechnology: General

  • Why Talk Of A Hepatitis C Price War Should Act As A Warning To The Pharma Industry-At-Large (Forbes)

US: Medical Devices

  • FDA panel backs use of Boston Scientific anti-stroke device (Reuters) (MedPage Today) (Press) (Mass Device)
  • Hamburg: mHealth requires scientific evidence (Fierce)
  • Your Guide to 2013's Must-Read FDA Documents (MDDI)
  • AdvaMed, MDMA commend user fee relief as congressional budget vote approaches (Fierce) (Press)
  • Boosting pipeline of medical devices for children (MNT)
  • White paper: testing Wi-Fi functionality in medical devices (Medical Design)

US: Assorted And Government

  • Reps. to introduce bill for antibiotic pathway, breakpoints (BioCentury)
  • Congress advancing FY14 top-line budget, appropriations to come (BioCentury)
  • The FD&C Act Turned 75 This Month (FDAAA)
  • Cancer research group urges sequestration relief (The Hill)
  • Emerging Company Policy Deconstructed: Fostering Innovation Act (H.R. 2629) (BIO)

Upcoming Meetings And Events

  • 10-11 December: FTC Meeting on Biosimilars (FTC)
  • 11 December 2013: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (FDA)
  • 11 December 2013: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 11-12 December 2013: Allergenic Products Advisory Committee Meeting (FDA)
  • 12 December 2013: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • EMA Unveils New Pharmacovigilance Practice Guidelines (EMA) (EMA) (EMA) (EMA)
  • French give go-ahead to biosimilar substitution (SCRIP-$)
  • UK ortho industry moves to strengthen EU post-market surveillance (Clinica-$)
  • Device supervision, reprocessing are key issues in new EU regs as Greeks commit to challenge (Clinica-$)
  • Ireland resists tougher EU device regulations (Fierce)
  • Novartis awaits pivotal Bexsero decisions in Canada and Europe (Fierce)
  • Sorin Group Gets CE Mark Approval for Intensia Family of Cardiac Implants with DF-4 High Voltage Connectors (MedGadget)
  • St. Jude Medical Gains CE Mark for 25 mm Portico Transcatheter Aortic Heart Valve (Press)

Asia

General Regulatory And Interesting Articles

  • Are too many kids taking antipsychotic drugs? (Consumer Reports)
  • Malaria control efforts saved 3.3 million since 2000, WHO says (Reuters)
  • For an Influenza Vaccine, Are Two Bs Better Than One? (NEJM)
  • Bristol adds medicine to patent pool for AIDS drugs (Reuters)
  • Cancer deaths rise to 8.2 million, breast cancer sharply up (Reuters)
  • Men With Pelvic Pain Find a Path to Treatment Blocked by a Gynecology Board (NYTimes)

Regulatory Reconnaissance #220 - 12 December 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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