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Regulatory Recon: 2016 User Fees are Here! Plus, '100% Effective' Ebola Vaccine and Cybersecurity Woes (3 August 2015)

Posted 03 August 2015 | By Michael Mezher 

Regulatory Recon: 2016 User Fees are Here! Plus, '100% Effective' Ebola Vaccine and Cybersecurity Woes (3 August 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher and @RAPSorg on Twitter.

In Focus: US

  • FDA warns of security flaw in Hospira infusion pumps (Reuters) (MassDevice) (FDA)
  • US Capitol Capsule: The vaccine pursuit: Not for the faint of heart (SCRIP-$)
  • New cocktails to test limits of cancer drug pricing (Reuters)
  • Guidance on Adverse Event Reporting for Outsourcing Facilities Under Section 503B of FD&C Act (FDA)
  • Full Speed Ahead: FDA’s Expedited Access Pathway (MDDI)
  • Biosimilar States Follow FDA Definition of Interchangeability (FDANews)
  • House Asks President for Help on Sunscreen Ingredient Approvals (Tan Sheet-$)
  • Public Workshop: Promoting Semantic Interoperability of Laboratory Data (FDA)
  • Patient-Focused Drug Development for Nontuberculous Mycobacterial Lung Infections (FDA)
  • Public Workshop: Surrogate Endpoints for Clinical Trials in Kidney Transplantation (FDA)

In Focus: International

  • World on the Verge of an Effective Ebola Vaccine Following Strong Phase III (WHO) (The Lancet) (FierceBiotech) (WSJ-$) (NPR) (Washington Post) (SCRIP-$) (Press)
  • Stalled TPP gives generics more time to push back (SCRIP-$) (Law360-$)
  • MHRA advises the Cell Therapy Catapult of regulatory requirements (MHRA)
  • Opinion: EU should learn from Australia on drug approval process (EurActiv)
  • EMA grants rapid reviews for two new myeloma drugs (SCRIP-$)
  • Possible Exploitation of Compulsory Licenses in India (TwoFour Insight)
  • FDA denies approval for SPARC's anti-glaucoma eyedrop over GMP deficiencies (Economic Times)
  • China Pushes For Lower Sovaldi Prices Amid Rising HCV Cases (PharmAsiaNews-$)
  • Japan Outpaces U.S., Europe in 2014 Drug Approvals (FDANews-$) (Focus)

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FDA User Fees:

  • Prescription Drug User Fee Rates for Fiscal Year 2016 (FDA)
  • Medical Device User Fee Rates for Fiscal Year 2016 (FDA)
  • FY 2016 Medical Device User Fee Small Business Qualification and Certification (FDA)
  • Generic Drug User Fee Rates for Fiscal Year 2016 (FDA)
  • Biosimilar User Fee Rates for Fiscal Year 2016 (FDA)
  • Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2016 (FDA)
  • Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2016 (FDA)
  • Outsourcing Facility Fee Rates for Fiscal Year 2016 (FDA)
  • Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2016 (FDA)

Want to learn more about user fees? Check out the newly released US Fundamentals of Regulatory Affairs, Ninth Edition, which features an all new chapter on user fees.

User Fee Commentary:

  • FDA Publishes Fiscal Year 2016 User Fee Rates; Only a Modest Increase in PDUFA/BsUFA Rates, But Significant Hikes for Some GDUFA Fees (FDA Law Blog)
  • FDA 2016 User Fees Hold Steady For Brands, But Are Up – And Down – For Generics (Pink Sheet-$)
  • PDUFA Fees To See Small Rate Increase In 2016 (Pink Sheet-$) (BioCentury)
  • GDUFA Fee Adjustments: Facilities Will Pay Less, ANDA Filers More in 2016 (Pink Sheet-$)
  • FDA raises medical device user fees more than 4% (MassDevice) (Gray Sheet-$)
  • Fiscal 2016 User Fees Going Up for NDAs, BLAs and ANDAs (FDANews-$)

US: Pharmaceuticals and Biotechnology

  • US Capitol Capsule: The vaccine pursuit: Not for the faint of heart (SCRIP-$)
  • Foreign medications endanger Florida patients (DrugWonks)
  • Less-Addictive Opioids Could Boost Drug Firms' Image (NPR)
  • US firm offers CRISPR viral knock-out library for R&D (BioPharma-Reporter)
  • Unichem Pharmaceuticals (USA), Inc. Issues a Voluntary Nationwide Recall of Hydrochlorothiazide Tablets Due to the Potential Presence of Foreign Tablets (FDA)
  • New cocktails to test limits of cancer drug pricing (Reuters)

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

  • Lexicon's Phase III TELESTAR Study Meets Goals (Press)
  • Medivir announces that Janssen has started a phase I study to evaluate the effect of simeprevir and odalasvir on AL-335 pharmacokinetics (Press)
  • Cidara Therapeutics Initiates Phase 1 Study of Lead Antifungal Product Candidate CD101 IV (Press)
  • Phase III Data on Baxalta’s Investigational Treatment for Von Willebrand Disease (Press)

US: Pharmaceuticals and Biotechnology: General

  • Guidance on Adverse Event Reporting for Outsourcing Facilities Under Section 503B of FD&C Act (FDA)
  • Quality Metrics – Coming Soon to Your Manufacturing Facility (The 505(b)(2) Blog) (Focus)
  • FDA’s Quality Metrics Proposal Poses Challenges, Including 'Gaming,' Cost (Pink Sheet-$)
  • Opinion: Replace Sovaldi with Ebola Vaccine to see how Short Sighted Cost Complaints are (DrugWonks)

US: Medical Devices

  • FDA warns of security flaw in Hospira infusion pumps (Reuters) (MassDevice) (FDA)
  • Full Speed Ahead: FDA’s Expedited Access Pathway (MDDI)
  • GAO review of device tax reveals more about the impact of the ACA on Medicare reimbursement (FierceMedicalDevices) (Gray Sheet-$) (GAO)
  • Intuitive Still Dominates, But Emerging Robotic Surgery Players Seek To Speed Penetration (Gray Sheet-$)
  • Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation (FDA)
  • Scientists create noninvasive spinal stimulation tech to help paralyzed move (FierceMedicalDevices)
  • DoD taps FDA-cleared device for battlefield diagnosis of traumatic brain injuries (MobiHealthNews)
  • Connectors Conform to Medical Device Design (MDDI)

US: Assorted and Government

  • Biosimilar States Follow FDA Definition of Interchangeability (FDANews)
  • House Asks President for Help on Sunscreen Ingredient Approvals (Tan Sheet-$)

Upcoming Meetings and Events                                                            

  • RAPS' FDA Advisory Committee Meeting Tracker
  • Public Workshop: Promoting Semantic Interoperability of Laboratory Data (FDA)
  • Patient-Focused Drug Development for Nontuberculous Mycobacterial Lung Infections (FDA)
  • Public Workshop: Surrogate Endpoints for Clinical Trials in Kidney Transplantation (FDA)
  • Sixth Annual Coalition Against Major Diseases/Food and Drug Administration Scientific Workshop (FDA)

Europe

  • MHRA advises the Cell Therapy Catapult of regulatory requirements (MHRA)
  • Opinion: EU should learn from Australia on drug approval process (EurActiv)
  • EMA grants rapid reviews for two new myeloma drugs (SCRIP-$)
  • EC Authorizes Omeros' Omidria for use in Cataract Surgery (Press)

India                                                                                                          

  • Possible Exploitation of Compulsory Licenses in India (TwoFour Insight)
  • Wockhardt recalls over 50 lakh bottles of various drugs in US (Economic Times)
  • FDA imposes import alert on some Himalaya Drug Company products (Economic Times)
  • FDA denies approval for SPARC's anti-glaucoma eyedrop over GMP deficiencies (Economic Times)
  • J P Nadda: 9,092 drug samples found to be substandard in last three years (Economic Times)

China

  • China Pushes For Lower Sovaldi Prices Amid Rising HCV Cases (PharmAsiaNews-$) 

Japan

  • Japan Outpaces U.S., Europe in 2014 Drug Approvals (FDANews-$) (Focus)

Canada

  • Notice to Stakeholders - Updates to drug establishment license applications and good manufacturing practice evidence requirements for active pharmaceutical ingredients (Health Canada)

Australia

  • Australia walks away from Trans-Pacific Partnership trade deal talks (The Gaurdian)
  • Children's medicines supplied in bottles that may be faulty (TGA)
  • Medicines Safety Update Volume 6 Number 4, August 2015 (TGA)

Ebola Outbreak

Other International

  • Stalled TPP gives generics more time to push back (SCRIP-$) (Law360-$)

General Health and Interesting Articles

  • Preparing Ahead – When Events Overtake Communications (Eye on FDA)
  • Toxic Lead Contaminates Some Traditional Ayurvedic Medicines (NPR)

Regulatory Reconnaissance #609– 3 August 2015

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.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


Categories: Recon, Regulatory News

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