Regulatory Focus™ > News Articles > Regulatory Recon: FDA Preps for Turbulence as User Fees, 'Cures' Act and Elections Approach (30 July

Regulatory Recon: FDA Preps for Turbulence as User Fees, 'Cures' Act and Elections Approach (30 July 2015)

Posted 30 July 2015 | By Michael Mezher 

Regulatory Recon: FDA Preps for Turbulence as User Fees, 'Cures' Act and Elections Approach (30 July 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

  • User fees, 'Cures,' elections: FDA bracing for the crash (SCRIP-$)
  • The Times They Are a Changin’ – And So is FDA (FDA Voice)
  • The Science Board to the US FDA Hears Updates About Science at the FDA, New Proposed Legislation (SAC Tracker)
  • PCSK9 Inhibitors: Bargain Among Biologics? (Medpage Today)
  • Serious Risks About Existing Drugs Aren’t Given to Trial Participants (Pharmalot)
  • DTC Rx Drug Ad Study No. 30: Do Market Claims Impact Perception? (Pink Sheet-$) (Focus)
  • FDA Responds to Nagging Questions About “Lagging” Drug Review Divisions (RPM Report-$)
  • OTC Regulatory Pathway Needs NDA Flexibility, Monograph Scope – Sharfstein (Pink Sheet-$)
  • 2015 could see most device approvals for a decade (EP Vantage)
  • Robotic Surgery Devices Are Tools, Not Instruments, Say Physicians, Industry (Gray Sheet-$)
  • The Veloxis Case: Uncut, Unrated, and Unsealed! (FDA Law Blog)

In Focus: International

  • Regulatory information – Rules on fees are revised (EMA)
  • CRO vs HRA trial transparency case ends in a win for industry (Outsourcing-Pharma)
  • UK HRA to review 'confusing' trial registration requirements (SCRIP-$) (Pink Sheet-$)
  • High Court rejects AstraZeneca’s diabetes drug plea (Economic Times)
  • Fresh twists and turns in Indian Herceptin biosimilars case (SCRIP-$)
  • 'Rough notes' and backdated signatures land Indian API maker US FDA warning (In-Pharma Technologist)
  • Patent Protection for Drugs Puts Pressure on U.S. in Trade Talks (NYTimes)
  • Ukraine: 'Two months' to know if medtech reg system is workable (Clinica-$)
  • ICH Revises Guidance on Two Pharmaceutical Solvents (FDANews-$)

US: Pharmaceuticals and Biotechnology

  • User fees, 'Cures,' elections: FDA bracing for the crash (SCRIP-$)
  • PCSK9 Inhibitors: Bargain Among Biologics? (Medpage Today)
  • Serious Risks About Existing Drugs Aren’t Given to Trial Participants (Pharmalot)
  • DTC Rx Drug Ad Study No. 30: Do Market Claims Impact Perception? (Pink Sheet-$) (Focus)
  • Testicular Toxicity In Drug Trials: An ‘Uncommon But Persistent Challenge’ (Pink Sheet-$)
  • Will There Be Another Drug Label Change For YAZ And Other Drospirenone Birth Control Pills (Drug Injury Watch)
  • Gastros Speak Up on Biosimilars vs. Biologics for IBD (MPR)
  • New tool uses 'drug spillover' to match cancer patients with treatments (MNT)
  • Janssen Hit With Another Levaquin Nerve Damage Suit (Law360-$)
  • J&J, Janssen Face Risperdal Suit From Cherokee Nation (Law360-$)

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

  • Roche submits filing to FDA for companion diagnostic for non-small cell lung cancer drug therapy (Press)
  • KaloBios Announces FDA Clearance of Investigational New Drug Application for KB003 in Patients with Chronic Myelomonocytic Leukemia (Press)
  • FDA Acceptance of Naloxone Nasal Spray NDA With Priority Review (DD&D)
  • Synergy Pharmaceuticals Announces Positive Results in the Second Phase 3 Trial of Plecanatide in Patients with Chronic Idiopathic Constipation (Press)
  • Astellas Provides Update on Phase 3 Study Evaluating Isavuconazole in Patients with Candidemia and Other Invasive Candida Infections (Press)
  • Eisai Submits Applications for Anticancer Agent Halaven Simultaneously In Japan, US and Europe Seeking New Indication as Treatment for Soft Tissue Sarcoma (Press)
  • Roche submits filing to FDA for companion diagnostic for non-small cell lung cancer drug therapy (Press)
  • Rayaldee NDA Accepted for SHPT in Stage 3 or 4 CKD and Vitamin D Deficiency (MPR)
  • Medivir announces start of a phase I clinical trial of the nucleotide polymerase inhibitor AL-704 for treatment of hepatitis C (Press)
  • D-Pharm Receives Final Report for Phase 2 Clinical Study of DP-b99 in Acute High-Risk Pancreatitis Patients (Press)
  • GI Dynamics Ends ENDO Trial Over Hepatic Abscess Risk (Press)
  • Eisai’s Lenvima receives Breakthrough Therapy designation for renal cell carcinoma (European Pharmaceutical Review)
  • Inj Combo Diabetes Drug: Phase 3 Results Announced (MPR)

US: Pharmaceuticals and Biotechnology: General

  • The Times They Are a Changin’ – And So is FDA (FDA Voice)
  • FDA Responds to Nagging Questions About “Lagging” Drug Review Divisions (RPM Report-$)
  • Penn bioethicists call for end to 'pay-to-play' clinical research (MNT)
  • OTC Regulatory Pathway Needs NDA Flexibility, Monograph Scope – Sharfstein (Pink Sheet-$)

US: Medical Devices

  • 2015 could see most device approvals for a decade (EP Vantage)
  • Robotic Surgery Devices Are Tools, Not Instruments, Say Physicians, Industry (Gray Sheet-$)
  • New approach to MRI could slash length of scans (MNT)
  • FDA Clears First 3D-Printed, Load-Bearing Polymer Implant (MedDeviceOnline)
  • Mayo Clinic LVAD Study Suggests Market Expansion (MedDeviceOnline)
  • NeuWave wins FDA nod for Ablation Confirmation software (MassDevice) (Exome)
  • Corvida Medical’s Halo Hazardous Meds Transfer System FDA Cleared (medGadget)
  • TSO3 Pursues Extended Claims for the STERIZONE Sterilization System (ICT)
  • Bio-Rad Labs grabs FDA approval for next-gen HIV test (FierceDiagnostics)
  • Cloud9 Anti-Snoring System Approved for Adults (MPR) (FierceMedicalDevices)
  • Chlamydia screening 'easier and cheaper' with new DNA smartphone test (MNT) (FierceDiagnostics)
  • Advantages of Sterile Single-Use Instrumentation for Lumbar Fusion Confirmed in a U.S. Clinical Study (ICT)
  • Early evidence suggests hybrid cochlear implants may benefit millions with common form of hearing loss (MNT)
  • ARROW Endurance™ Extended Dwell Peripheral Catheter System Receives FDA Market Clearance (Press)

US: Assorted and Government

  • The Veloxis Case: Uncut, Unrated, and Unsealed! (FDA Law Blog)
  • Cruz’ Take On “Cures”: Tea Party Senator Jumps Into FDA Reform Debate (RPM Report-$)
  • Another California County Wants Pharma to Pay for Drug Take-Backs (Pharmalot)
  • Calif. Vaccine Law Opponents Launch Campaign To Recall Sen. Pan (California Healthline)
  • Drugs stolen while trucker changed his clothes recovered thanks to hidden GPS (In-Pharma Technologist)
  • Apertus Pharmaceuticals Cleared to Manufacture Marihuana (DEA)

Upcoming Meetings and Events                                                            

Europe

  • Regulatory information – Rules on fees are revised (EMA)
  • CRO vs HRA trial transparency case ends in a win for industry (Outsourcing-Pharma)
  • UK HRA to review 'confusing' trial registration requirements (SCRIP-$) (Pink Sheet-$)
  • First ADHD treatment recommended through EU centralised authorisation procedure (PJ Online)
  • Biotronik wins CE Mark for new MRI-safe pacemakers (MassDevice)
  • Emba Medical wins CE Mark for Hourglass embo device (MassDevice)
  • BMS slams restricted NICE yes for Daklinza (SCRIP-$)
  • New study data show reduced intracranial pressure using therapeutic hypothermia (MNT)
  • Eisai Submits Applications for Anticancer Agent Halaven Simultaneously In Japan, US and Europe Seeking New Indication as Treatment for Soft Tissue Sarcoma (Press)

India

  • High Court rejects AstraZeneca’s diabetes drug plea (Economic Times)
  • Fresh twists and turns in Indian Herceptin biosimilars case (SCRIP-$)
  • 'Rough notes' and backdated signatures land Indian API maker US FDA warning (In-Pharma Technologist)
  • Indian diagnostics outfit debuts 'lab-on-cartridge' device for developing countries (FierceMedicalDevices)

China

  • China FDA says sponsors must verify data in drug applications (BioCentury)

Japan

  • Japanese Approval Trial for Stress Urinary Incontinence Using Cytori Cell Therapy Announced (Press)
  • Eisai Submits Applications for Anticancer Agent Halaven Simultaneously In Japan, US and Europe Seeking New Indication as Treatment for Soft Tissue Sarcoma (Press)

Canada

Australia

  • Issues affecting documentation attached to some GMP clearance applications (TGA)

Ebola Outbreak

  • New Ebola Cases Decline, but W.H.O. Advises Caution (NYTimes)

Other International

  • Ukraine: 'Two months' to know if medtech reg system is workable (Clinica-$)
  • ICH Revises Guidance on Two Pharmaceutical Solvents (FDANews-$)
  • Bioscience will accelerate East-West convergence in the century ahead (Brookings)
  • Call for trade negotiators to uphold governments’ commitments to public health and access to medicines (UNAIDS)
  • Patent Protection for Drugs Puts Pressure on U.S. in Trade Talks (NYTimes)
  • Turkey Regulatory Update: Faster Approvals and Better Access (PharmAsiaNews-$)
  • GSK sales rise, but new bribery allegations emerge (PharmaTimes)

General Health and Interesting Articles

  • A Drug Hits Cycling Before It Hits the Market (NYTimes)
  • Doctor Whose Drug Killed Teen Returns as Gene Tech Booms Again (Bloomberg)
  • Scientists find five different types of prostate cancer (OnMedica)
  • Opinion: The Case for Fetal-Cell Research (NYTimes)
  • Flesh-eating bacteria kills Virginia fisherman (Reuters)
  • Legionnaires’ Disease Sickens 31, 2 Fatally, in the South Bronx (NYTimes)

Regulatory Reconnaissance #607– 30 July 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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