Regulatory Focus™ > News Articles > Regulatory Reconnaissance: FDA Advisory Committee Votes Against Changing Painkiller Labels (12 Febru

Regulatory Reconnaissance: FDA Advisory Committee Votes Against Changing Painkiller Labels (12 February 2014)

Posted 12 February 2014 | By Alexander Gaffney, RAC

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In Focus: US

In Focus: International

US: Pharmaceuticals/Biotechnology

  • FDA Panel Votes Against Changing Painkiller Labels (WSJ-$) (Pharma Letter-$) (Tan Sheet-$) (SCRIP-$) (MedIndia) (Pink Sheet-$) (MM&M) (Fierce) (AP) (MedPage Today) (Reuters) (Pfizer)
  • FDA hits back at charge of gender bias in libido drug decision (Reuters)
  • 'Female Viagra' now on track for Q3 filing in USA (Pharma Times)
  • FDA postpones serelaxin meeting (BioCentury) (Pink Sheet-$)
  • Doctors Question Safety of Recently-Approved Weightloss Drugs (Press)
  • FDA Memo Presses Staff To Ensure Broad Inclusion In Drug Trials (IHP-$)
  • New Jersey Introduces Biosimilar Substitution legislation (Scout)
  • FDA Contract for Data Safety Management (FDA)
  • Steering for a U.S. comeback, AstraZeneca's Brilinta runs aground on DoJ investigation (Fierce)
  • Nominations to the Advisory Committee on Blood and Tissue Safety and Availability (DHHS)
  • Vaccines and Related Biological Products Advisory Committee; Notice of Meeting (FDA)
  • Synergizing Efforts in Standards Development for Cellular Therapies and Regenerative Medicine Products; Public Workshop (FDA)
  • Anti-Infective Drugs Advisory Committee; Notice of Meeting (FDA)
  • Hamburg Statement on Trip to India (FDA)
  • Congress Hearing on Drug Shortages (E&C)
  • FDA says products recalled by compounder are contaminated (Fierce)

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

  • Actelion's Lung Drug May Face Study Against Gilead Rival (Bloomberg)

US: Medical Devices

  • How to Sharpen Your Regulatory Sword (MDDI)
  • Meetings: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee (FDA)
  • Requests for Nominations: HIT Standards Committee and HIT Policy Committee (DHHS)
  • MedShape wins 510(k) clearance for femoral fixation device (Mass Device)
  • Hansen Medical soars on FDA win for smaller robotic catheter (Mass Device)
  • Aurora Spine lands 510(k) nod from FDA for spinal fusion implants (Mass Device)
  • Alivecor receives FDA over-the-counter clearance for its heart monitor (Press)
  • DEKA Medical Receives FDA Clearance for the Synchro REPLA:Y (Press)
  • Interventional Spine, Inc. Announces FDA Clearance of Additional Sizes of Opticage Expandable Interbody Fusion Device (Press)

US: Dietary Supplements

  • Following the Do's and Don'ts of Joint Health Claims (NPI)

US: Assorted And Government

  • Jacques leaving CMS (BioCentury)
  • Meetings: Chronic Fatigue Syndrome Advisory Committee (DHHS)

Upcoming Meetings And Events

  • 10-11 February 2014: Joint Meeting of the Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee Meeting (FDA)
  • 12 February 2014: Cardiovascular and Renal Drugs Advisory Committee Meeting (FDA)
  • 13 February 2014: Cardiovascular and Renal Drugs Advisory Committee Meeting (FDA)
  • 14 February 2014: Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 19 February 2014: FDA OAGS Small Business Outreach Vendor Fair (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)



Japan & China

  • Chinese Pharma Industry Faces Challenges With EU's New Regulations On Counterfeit Drugs (PharmAsia-$)
  • Exclusive: U.S. Chamber Lobbies Against China Drug Registration Revisions That Would Favor Local Generics (PharmAsia-$)

Other International

  • Celgene multiple myeloma drug Pomalyst OK'd in Canada (SCRIP-$)

General Regulatory And Interesting Articles

  • Paying twice: questions over high cost of cystic fibrosis drug developed with charitable funding (BMJ)
  • Horribly depressing news about mammograms (TIE)
  • MIT robot may accelerate trials for stroke medications (MNT)

Regulatory Reconnaissance #255 - 12 February 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.

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Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at

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