Regulatory Focus™ > News Articles > Regulatory Reconnaissance (31 October 2013)

Regulatory Reconnaissance (31 October 2013)

Posted 31 October 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

  • FDA Sets New Rules to Better Address Drug Shortages (WSJ-$)
  • Feds launch probe of AstraZeneca's controversial late-stage Brilinta study (Fierce) (Reuters)
  • Ariad Pulls Cancer Drug Off The Market as Trial Fallout Continues (Xconomy) (Reuters)
  • Trick or Treat? FDA's licorice warning (Food Quality News)
  • Import Supplement Safety Concerns Spark NDI Notification Request (Tan Sheet-$)

In Focus: International

  • IQWiG's First Cost-Effectiveness Review Could Take Drug HTA To New Frontiers (Pink Sheet-$)
  • Janssen-Cilag submits EMA Marketing Authorization for ibrutinib (Pharma Letter-$) (PMLive) (BioCentury)
  • Third successful citizens' petition calls for end to animal testing (EurActiv)
  • BDR Pharma's application for compulsory licence for BMS's patented cancer drug dasatinib rejected (PharmaBiz) (India Times) (SCRIP-$)

US: Pharmaceuticals/Biotechnology

  • FDA Sets New Rules to Better Address Drug Shortages (WSJ-$)
  • Feds launch probe of AstraZeneca's controversial late-stage Brilinta study (Fierce) (Reuters)
  • Ariad Pulls Cancer Drug Off The Market as Trial Fallout Continues (Xconomy) (Reuters)
  • Joint Drafting of Contract Manufacturing Quality Agreements Needed to Reflect Shared Quality Ownership, FDA Stresses (IPQ-$)
  • Does The FDA Really Enforce A Conflicts Policy For Advisory Panels? (Pharmalot)
  • Trick or Treat? FDA's licorice warning (Food Quality News)
  • "Discuss With Your Doctor" Can Be Misleading Promotional Claim, FDA Says (Pink Sheet-$)
  • FDA Lays Out Post-GDUFA Implementation Plans: A Brave New World or A Modern Utopia in the Making? (FDA Law Blog) (Lachman)
  • The Pills of Last Resort: How Dying Patients Get Access to Experimental Drugs (NYTimes)
  • A questionable FDA decision on new painkiller (JS)
  • FDA Continues Case-By-Case Approach To Painkillers With Pure Hydrocodone Approval (IHP-$)
  • The FDA: Too Loose, Or Appropriately Brave? (In The Pipeline)
  • Novartis throws hat in biosimilar naming ring (BioCentury) (IHP-$)
  • You may know a drug cocktail is dangerous before FDA (CNBC)
  • Array Biopharma Outlines Path To Market For New Myeloma Drug (Forbes)
  • GAO Issues Report on Health Fraud Control Programs; Cites FDA's Pharma Fraud Efforts (GAO)
  • Charleston's CL-108 meets in Phase III trial pain trial (BioCentury)
  • Is Plavix-Related Hemophilia Side Effect Significant Enough For Label Change In Europe But Not In U.S.? (Drug Injury Watch)
  • FDA's MedWatch Safety Alerts: September 2013 (FDA)

US: Pharmaceuticals and Biotechnology: General

  • HHS will allow copay coupons for insurance through exchanges (BioCentury)
  • Victims Of Tainted Steroid Injections Still Struggling (NPR)

US: Medical Devices

  • HP 3-D printers focus on producing medical implants, not being a household gadget (MedCity News)
  • FDA clears Tria Beauty's Age-Defying Laser (DSN)
  • NLT Spine's Prow Fusion and eSPIN Receive 510(k) Clearance (Press)
  • Editor's Note: Oddly slow day for medical device news…

US: Dietary Supplements

  • Import Supplement Safety Concerns Spark NDI Notification Request (Tan Sheet-$)
  • GE Pharma recalls dietary supplement over DMAA content (Nutra Ingredients)
  • FTC Says Marketer Exaggerated Weight Loss Claims (Law 360-$) (NPI) (FTC)

Upcoming Meetings And Events

  • 31 October 2013: Data Harmonization for Patient-Centered Clinical Research (IOM/PCORI)
  • 1 November 2013: Blood Products Advisory Committee Meeting  (FDA)
  • 4-5 November 2013: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee Meeting (FDA) (Day 2)
  • 5 November 2013: Hamburg Attending Bloomberg Innovation Event (BGov)
  • 8 November 2013: Ear, Nose and Throat Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 13 November 2013: Peripheral and Central Nervous System Drugs Advisory Committee Meeting (FDA)
  • 13 November 2013: Vaccines and Related Biological Products Advisory Committee Meeting (FDA)
  • 14 November 2013: Peripheral and Central Nervous System Drugs Advisory Committee Meeting (FDA)
  • 19 November 2013: Endocrinologic and Metabolic Drugs Advisory Committee Meeting (FDA)
  • 2-3 December 2013: AHWP/RAPS Joint Conference in Malasia (RAPS)
  • 9 December 2013: Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee (FDA)
  • 11 December 2013: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • IQWiG's First Cost-Effectiveness Review Could Take Drug HTA To New Frontiers (Pink Sheet-$)
  • Janssen-Cilag submits EMA Marketing Authorization for ibrutinib (Pharma Letter-$) (PMLive) (BioCentury)
  • Third successful citizens' petition calls for end to animal testing (EurActiv)
  • EMA Workshop on biosimilars takes place today (EMA)
  • European Commission Grants Orphan Designations to Ten Drugs (1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
  • Jacoti Gains CE Mark Approval for ListenApp Hearing Aid Software (MedGadget)
  • European Medicines Agency closed on 1 November 2013  (EMA)

Asia

  • BDR Pharma's application for compulsory licence for BMS's patented cancer drug dasatinib rejected (PharmaBiz) (India Times) (SCRIP-$)
  • Granules calls for greater Indian regulatory efficiency (In-Pharma)

General Regulatory And Interesting Articles

  • The State of Infectious Diseases Clinical Trials: A Systematic Review of ClinicalTrials.gov (NCTN)
  • Rethinking the Vulnerability of Minority Populations in Research (NCTN)
  • First ticket issued for wearing Google Glass while driving (MedCity News)

Regulatory Reconnaissance #192 - 31 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.


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe