Regulatory Focus™ > News Articles > Regulatory Reconnaissance: FDA Regains Access to Sequestered User Fees (21 January 2014)

Regulatory Reconnaissance: FDA Regains Access to Sequestered User Fees (21 January 2014)

Posted 21 January 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.

In Focus: US

In Focus: International

  • European Commission Grants Marketing Authorization for Gilead's Hepatitis C Drug Sovaldi (Sofosbuvir) (Press) (Pharmafile) (Pharma Times) (Fierce) (PMLive) (SCRIP-$) (BioCentury)
  • A pocket guide to the future EU clinical trials environment (SCRIP-$)
  • India's deputy drug controller held on bribery charges (BioSpectrum)
  • Indian Health ministry to consult IPC on proposal to mention storage conditions on labels of drugs (PharmaBiz)
  • Revised Rules For Japan's Medical Devices Could Mean Speedier Time To Market (Gray Sheet-$)
  • Novartis employees may have violated trial protocol in Japan (Reuters)
  • Drugmakers reject lobbyists' South African "ground zero" patent plan (Pharma Times)

US: Pharmaceuticals/Biotechnology

  • QIDP Designations Show GAINs (Pink Sheet-$)
  • Antibiotic Development Incentives Face Critical Test As NDA Reviews Begin (Pink Sheet-$)
  • Comparative Effectiveness May Be Next Battleground For First Amendment Fight With FDA (Pink Sheet-$)
  • Woodcock: FDA Not Ready To Spin Sentinel Into National Information Database (IHP-$)
  • Schumer Calls on Drug Makers to Add Safety Devices to Children's Medicines Within a Year (ProPublica) (Press) (AP)
  • 2013 505(b)(2) NDA Approvals (Camargo)
  • Janssen Faces Prospect Of New Trial ForXarelto ACS Claim (Pink Sheet-$)
  • Antibiotics Legislation Could Boost Confidence Of Sponsors And FDA Alike (Pink Sheet-$)
  • On drug serialization requirements under the DQSA (RXTrace)
  • New Jersey legislation would require informed consent for pediatric disepensing of "black box" medications (Scout)
  • Unique Pharmaceuticals Registers as Outsourcing Facility with FDA (Press)

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

  • Setback for Roche schizophrenia drug bitopertin (Pharma Times) (Pharmafile) (Reuters) (SCRIP-$) (PMLive)
  • FDA rejects Amarin appeal on Vascepa trial design (Reuters)
  • FDA Grants Orphan Drug Designation to Soliris (eculizumab) for Prevention of Delayed Graft Function (DGF) in Renal Transplant Patients (Press)
  • Prosensa heralds new hope for once-failed muscular dystrophy drug (Fierce)
  • Pluristem stem cell trial to treat muscle injury meets main goal (Reuters)
  • Mayo wins FDA approval to test stem-cell technique for heart patients (MedCity News)
  • AbbVie advances oncology drug (Pharmafile)
  • CytRx Receives FDA Approval to Extend Aldoxorubicin Dosing Cycles until Disease Progression in Upcoming Pivotal, Global Phase 3 Trial for Soft Tissue Sarcomas (Press)
  • VIVUS and Auxilium Announce FDA Acceptance of Supplemental Filing Seeking an Update of Prescribing Information for STENDRA (avanafil) (Press)

US: Pharmaceuticals and Biotechnology: General

  • Drug Cos. Say Noerr Doctrine Bars FTC's Pay-For-Delay Suit (Law 360-$)

US: Medical Devices

US: Dietary Supplements

  • Study notes increasing questions about children and caffeine (The Hill)
  • Reaction to IOM's final report on caffeine meeting: More data needed, but new regs unlikely (NI-USA) (Food Product Design)
  • FDA Finalizes 2009 Draft Guidance on Distinguishing Liquid Dietary Supplements from Beverages (FDA Law Blog)
  • Thyroid Supplements With a Kick (NYTimes)

US: Assorted And Government

Upcoming Meetings And Events

  • 28 January 2014: Allergenic Products Advisory Committee Meeting (FDA)
  • 28 January 2013: US State of the Union Address (White House)
  • 28-29 January 2013: Workshop - Strategies to Address Hemolytic Complications of Immune Globulin Infusions (FDA)
  • 29-30 January 2014: Science Advisory Board to the National Center for Toxicological Research Meeting (FDA)
  • 19 February 2014: FDA OAGS Small Business Outreach Vendor Fair (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • European Commission Grants Marketing Authorization for Gilead's Hepatitis C Drug Sovaldi (Sofosbuvir) (Press) (Pharmafile) (Pharma Times) (Fierce) (PMLive) (SCRIP-$) (BioCentury)
  • A pocket guide to the future EU clinical trials environment (SCRIP-$)
  • Netherlands medical devices compliance update (MedicalDevicesLegal)
  • Trends in initial evaluation of veterinary medicines by EMA in 2013 (EMA)
  • EU reliance on API imports is 'alarming' says EFCG (In-Pharma)
  • Greatbatch requests CE Mark for spinal cord stim (Mass Device)
  • Bisphenol A: EFSA consults on assessment of risks to human health (EFSA)

India

  • India's deputy drug controller held on bribery charges (BioSpectrum)
  • Indian Health ministry to consult IPC on proposal to mention storage conditions on labels of drugs (PharmaBiz)
  • Should the CDSCO Change its Name? (PharmaBiz)
  • Indian Medical Technology Assessment Board to be set up to conduct Comparative Effectiveness Research (PharmaBiz)
  • Indian Health ministry constitutes panel to prepare guidelines for regulating transportation of drugs in the country (PharmaBiz)
  • Indian Health ministry plans amendment to labelling rules to avoid unnecessary information on packs (PharmaBiz)
  • Ranbaxy working on Plan B to get Diovan generic on track? (SCRIP-$)
  • Biocon plans February launch for first biosimilar Herceptin (PMLive) (Pharma Times) (Reuters) (SCRIP-$)
  • Biocon breast cancer drug too expensive, say health activists (India Times)

Japan & China

  • Revised Rules For Japan's Medical Devices Could Mean Speedier Time To Market (Gray Sheet-$)
  • Novartis employees may have violated trial protocol in Japan (Reuters)
  • China's Anti-Corruption Investigation May Last At Least Three Years (PharmAsia-$)
  • Seattle Genetics Announces ADCETRIS (Brentuximab Vedotin) Approval in Japan for the Treatment of Relapsed or Refractory Hodgkin Lymphoma and Anaplastic Large Cell Lymphoma (Press)
  • Japan marks latest approval for Bayer's riociguat (SCRIP-$) (BioCentury)
  • Keryx's ferric citrate gets Japanese approval (BioCentury)
  • Japan Approves Astellas, Kotobuki New Class Of Diabetes Drug (PharmAsia-$) (BioCentury)
  • Tanabe Mitsubishi Files For Approval Of Telavic For Genotype 2 Hepatitis C In Japan (PharmAsia-$)

Other International

  • Drugmakers reject lobbyists' South African "ground zero" patent plan (Pharma Times)
  • As They Look To The U.S., Celltrion And Hospira Win Approval For Remicade Biosimilars In Canada (PharmAsia-$)
  • Mexico backs marketing of Aegerion's Juxtapid for HoFH (Pharma Letter-$)
  • New INMETRO, IEC 60601 requirements in Brazil (Mass Device)

General Regulatory And Interesting Articles

  • The role of labels in patient safety (Pharmaceutical Commerce)
  • Reviving a Life Saver, the Tourniquet (NYTimes)
  • Western Scientists Look To Chinese Medicine For Fresh Leads (NPR)
  • The 'No More Tears' Shampoo, Now With No Formaldehyde (NYTimes)
  • Enhancing bioavailability of healthful components in food using nanoparticle design (Press)
  • The Chemicals in Our Food (Marginal Revolution)

Regulatory Reconnaissance #239 - 21 January 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.


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