Regulatory Recon: A Changing of the Guard (2 July 2015)

Posted 02 July 2015 By Alexander Gaffney, RAC

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Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Today is my last day working at RAPS and writing Regulatory Reconnaissance (more on that here). Thank you all for your readership over the years. It's been incredible to see this morning news roundup grow from something read by 50 people per day to something read by 2,000 people every morning.

Fear not: Regulatory Recon isn't going away. News Editor Michael Mezher will be taking over as of Monday, 6 July 2015.

In Focus: US

  • Leaked: The Pharma Provisions in Obama's trade deal (Politico)
  • Should Kids Get Codeine For Cough? FDA Taking a Closer Look (NBC) (FDA)
  • Insider: WH Has Competition Concerns With FDA Biosimilar Naming Plans (IHP-$)
  • FDA seeks ways to break down walls surrounding data (ModernHealthcare)
  • FDA to Remove Two Biologics Regulations From the Books (FDA) (FDA)
  • FDA OKs second test to see if Essure contraceptive is placed right (Reuters) (Press)
  • Tips To App Developers: Know Your Agencies, Regulations (Gray Sheet-$)

In Focus: International

  • French court rules 'no error' by German body over faulty breast implants (TheSunDaily) (Reuters)
  • Groups Worried Too Much of EMA's Funding Comes from Industry (HAI Europe)
  • Mandatory use of common repository for human centralised procedures as of today (EMA)
  • UK health secretary calls for drug prices on medicine bottles (PharmJournal) (PMLive)

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US: Pharmaceuticals and Biotechnology

  • Should Kids Get Codeine For Cough? FDA Taking a Closer Look (NBC) (FDA)
  • Insider: WH Has Competition Concerns With FDA Biosimilar Naming Plans (IHP-$)
  • FDA seeks ways to break down walls surrounding data (ModernHealthcare)
  • FDA to Remove Two Biologics Regulations From the Books (FDA) (FDA)
  • Federal judge enters permanent injunction against Acino Products, LLC (FDA)
  • FDA warning letter lays out cross-contamination issues at Canada plant (Fierce)
  • FDA to Hold Workshop on Predicting Immunogenicity of Therapeutic Coagulation Proteins (FDA)
  • ASHP commends FDA's decision to extend Track and Trace enforcement to November 1, 2015 (Press)
  • FDA approves Spriaso's NDA for codeine antitussive with anti-histamine (PBR)
  • Activities For sNDA and Citizen's Petition Protected by "Safe Harbor" - Supplemental New Drug Application (NationalLawReview)

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

  • Gilead Submits New Drug Application to U.S. Food and Drug Administration for Single Tablet Regimen for HIV Containing Rilpivirine, Emtricitabine and Tenofovir Alafenamide (R/F/TAF) (Press)
  • Clovis Oncology Initiates Rolling NDA Submission to the FDA for Rociletinib in the Treatment of Advanced EGFR-Mutant Non-small Cell Lung Cancer (Press)
  • Exelixis falls on delayed cobimetinib NDA review (BioCentury)
  • Xenon tumbles after Phase IIb OA miss (BioCentury)

US: Pharmaceuticals and Biotechnology: General

  • ​​Lawsuit arising from massive pharmaceutical theft moves forward against ADT / Tyco (PharmPro)

US: Medical Devices

  • FDA OKs second test to see if Essure contraceptive is placed right (Reuters) (Press)
  • Tips To App Developers: Know Your Agencies, Regulations (Gray Sheet-$)
  • Robust Data Needed To Support Emerging Cardiac Arrest Treatments – IOM Report (Gray Sheet-$)
  • FDA expands Proteus Digital Health's clearance to include measuring medication adherence (MobiHealthNews) (Press)
  • FLOW-i Anesthesia Systems - Dislodged Patient Cassette May Stop Patient Ventilation (FDA)
  • Sanuwave updates on PMA trial for Dermapace (MassDevice)
  • Hansen Medical Announces FDA Clearance of the Magellan 10Fr Robotic Catheter (Press)

US: Dietary Supplements

  • IND guidance complicates research into immune health, forum participants told (NI-USA)
  • Serious Side Effects Seen With Herbal Supplement Added to Depression Tx (MPR)

US: Assorted And Government

  • Leaked: The Pharma Provisions in Obama's trade deal (Politico)

Upcoming Meetings and Events

Europe

  • French court rules 'no error' by German body over faulty breast implants (TheSunDaily) (Reuters)
  • Groups Worried Too Much of EMA's Funding Comes from Industry (HAI Europe)
  • Mandatory use of common repository for human centralised procedures as of today (EMA)
  • UK health secretary calls for drug prices on medicine bottles (PharmJournal) (PMLive)
  • Draft reflection paper on viral safety of plasma-derived medicinal products with respect to hepatitis E virus (EMA)
  • Novo Nordisk to end German sales of new insulin drug after price row (Reuters)
  • BI's COPD Maintenance Treatment Spiolto Respimat Approved in EU (Press) (PMLive)
  • Novo pulls Tresiba from Europe's biggest market (PMLive)
  • Novartis Withdraws Rasilamlo From Market (EC)
  • Market access for new specialist drugs will get harder, says NHS England (PharmaPhorum)
  • HTA Core Model Version 3.0 draft – comments welcome! (EUnetHTA)
  • Alcon wins CE Mark for AcrySof IQ PanOptix trifocal lens (MassDevice)
  • GlySure wins CE Mark for intravascular glucose monitor (MassDevice)

India

  • Health ministry to study foreign regulatory modules for consistent quality of drugs from India (PharmaBiz)

China

  • Manufacturing deal wins China cheap supply of GSK's new HIV drug (Reuters)

Other International

  • Malaysian Medical Device Regulators Ready Post-Marketing Requirements (Emergo)

General Regulatory And Interesting Articles

  • GMP assessments should consider environmental impact say campaigners (In-Pharma)
  • How a swine flu shot led to narcolepsy (CBS)

Regulatory Reconnaissance #588 – 2 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? Email news@raps.org.

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

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