Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Sebelius, DHHS Secretary, to Resign (11 April 2014)

Regulatory Reconnaissance: Sebelius, DHHS Secretary, to Resign (11 April 2014)

Posted 11 April 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.

Focus is putting together an advisory committee of Regulatory Intelligence professionals to help us inform and guide our coverage of regulatory events. Interested? Send us an email at news@raps.org with the subject line Regulatory Intelligence.

In Focus: US

  • Health Secretary Kathleen Sebelius To Step Down (NYTimes) (NPR) (SCRIP-$) (WaPo) (MedPage Today) (WSJ-$) (Reuters) (The Hill)
  • PDUFA 6 Could Make Breakthrough Status More Routine, Hamburg Says (Pink Sheet-$)
  • FDA's Temple Pushes Feasibility, Cost-Savings Of Large, Simple Trials (Pink Sheet-$)
  • Hamburg to PhRMA: If you don't have quality, the rest doesn't matter (Fierce)
  • Massachusetts' Ban on "Prescribing and Dispensing" Zohydro: The Arguments For and Against Preemption (Harvard Bill of Health)
  • Celladon's Mydicar 1st gene therapy FDA 'breakthrough' designation (SCRIP-$) (Fierce) (Pink Sheet-$)
  • FDA approves expanded indication for certain pacemakers and defibrillators used to treat heart failure  (FDA)

In Focus: International

  • Specifications for additional efficacy studies for medicines published in the Official Journal of the EU (EMA)
  • Novartis, Roche caught up in French antitrust probe (SCRIP-$) (Pharmafile) (FT-$) (Fierce)
  • The proposed EU regulations for medical and in vitro diagnostic devices: An overview of the likely outcomes and consequences for the market (BSI)
  • NICE to look again at Tamiflu after data saga (Pharmafile)
  • EMA's PRAC Publishes Reccomendations (EMA)
  • IPEC asks excipient industry to provide insight on elemental impurities (In-Pharma)
  • WHO investigates use of a biological qualifier for biosimilars (GaBi)

US: Pharmaceuticals/Biotechnology

  • PDUFA 6 Could Make Breakthrough Status More Routine, Hamburg Says (Pink Sheet-$)
  • FDA's Temple Pushes Feasibility, Cost-Savings Of Large, Simple Trials (Pink Sheet-$)
  • Hamburg to PhRMA: If you don't have quality, the rest doesn't matter (Fierce)
  • Massachusetts' Ban on "Prescribing and Dispensing" Zohydro: The Arguments For and Against Preemption (Harvard Bill of Health)
  • NH Senate Committee Considering 18 Month Ban on Zohydro (Champlain Valley)
  • NCPDP Issues Patient Safety Guidance on Dosing of Oral Liquid Medications (Press)
  • GPhA Calls for US-EU Convergence in Biosimilar and Generic Medicine Regulation (FDA Law Blog)
  • Big Decisions Loom in 2014 for Generic Applicants (Lachman)
  • Hamburg: Society needs to weigh in (BioWorld)
  • FDA Sought Written Input From Generic Drug Industry Before Issuing Labeling Rule (IHP-$)
  • Washington Legal Foundation Blasts FDA's Generic Drug Labeling Rule (WLF)
  • FDA Approves Lipiodol (Ethiodized Oil) Injection for Imaging of Tumors in Adults with Known Hepatocellular Carcinoma (HCC) (Press)
  • Merck Singulair Switch NDA Limits Indication to Allergies, Omits Asthma (Tan Sheet-$) (FDA)
  • HELP Committee Forms Prescription Drug Abuse Working Group (Senate) (The Hill)
  • WLF Faults FDA for Seeking to Expand Onerous Drug Approval Process to Food Studies (WLF)
  • Delaware Senate Unanimously Passes Biosimilar Interchangeability Legislation (Press)
  • Prospects for Regulation of Off-Label Drug Promotion in an Era of Expanding Commercial Speech Protection (SSRN)

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

  • Celladon's Mydicar 1st gene therapy FDA 'breakthrough' designation (SCRIP-$) (Fierce) (Pink Sheet-$)
  • Biogen's hemophilia hopeful scores a PhIII win as FDA awaits (Fierce)
  • TOPCAT Study Shows Spironolactone Did Not Reduce Serious Cardiovascular Events (Press)
  • Sloan-Kettering puts CAR therapy trials on hold (BioCentury)

US: Pharmaceuticals and Biotechnology: General

  • U.S. drug industry group defends price of Gilead hepatitis drug (Reuters)
  • BIDMC doc wants med journal to retract testosterone study (Boston Herald)
  • Doctors welcome hepatitis C drug rivals, Gilead still leads (Reuters)
  • PhRMA 2014: Republican-biopharma lovefest going strong (SCRIP-$)
  • PhRMA: Sunshine Not Driving Docs Indoors (MedPage Today)
  • Pfizer's Ian Read Becomes PhRMA Board Chairman (Press)

US: Medical Devices

  • FDA approves expanded indication for certain pacemakers and defibrillators used to treat heart failure  (FDA)
  • Efforts Accelerate To Add Unique Device IDs To Insurance Claims (Gray Sheet-$)
  • March 2014 510(k) Clearances (FDA)
  • Class 1 Recall for Draeger Oxylog 3000 Plus Ventilators due to Error Messages (FDA)
  • Covidien Implements Voluntary Recall of its Pipeline Embolization Device and Alligator Retrieval Device (Press)

US: Dietary Supplements

  • Dewmar's FDA warning letter a 'no-brainer': food and drug attorney (NI-USA)

US: Assorted And Government

Europe

  • Specifications for additional efficacy studies for medicines published in the Official Journal of the EU (EMA)
  • Novartis, Roche caught up in French antitrust probe (SCRIP-$) (Pharmafile) (FT-$) (Fierce)
  • The proposed EU regulations for medical and in vitro diagnostic devices: An overview of the likely outcomes and consequences for the market (BSI)
  • NICE to look again at Tamiflu after data saga (Pharmafile)
  • EMA's PRAC Publishes Reccomendations (EMA)
  • 2 patents down, 1 to expire: Herceptin biosimilar coming to EU (Biosimilar News) (PMLive) (Pharma Times) (Pharmafile)
  • PRAC recommends against combined use of medicines affecting the renin-angiotensin (RAS) system (EMA)
  • UK 'at risk' over personalised medicines, report warns (Pharma Times)
  • PRAC Begins Review of Ambroxol and Bromhexine (EMA)
  • Start of review of codeine-containing medicines when used for cough and cold in children (EMA)
  • Review of oral methadone medicines containing povidone started (EMA)
  • European Union Debates Initiative on Embryo Protection (NYTimes)
  • Huge haul of fake drugs seized in France (PharmaTimes) (Securing Industry)

Japan & China

  • ZhiFei's AC-Hib Vaccine Gets China FDA Approval (PharmAsia-$)

Other International

  • IPEC asks excipient industry to provide insight on elemental impurities (In-Pharma)
  • WHO investigates use of a biological qualifier for biosimilars (GaBi)
  • Health Canada Starts Consultation on Risk Management Guidance (Health Canada)
  • Fresenius Medical Care Recalls NaturaLyte Sodium Bicarbonate Liquid Concrentrate due to Bacterial Contamination (Health Canada)
  • Abbott Recalls Batch Of Anti-Platelet Drug In Philippines Due To Smell (PharmAsia-$)
  • Development of Iranian guidelines for 'biogenerics' (GaBI)

General Regulatory And Interesting Articles

  • Quality by design for biosimilars (GaBi)
  • Lancet studies: Nostrils, vaginas built from patients' own tissues are working well after implantation (MedCityNews) (WSJ-$)

Regulatory Reconnaissance #296 - 11 April 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.


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe