Regulatory Focus™ > News Articles > Regulatory Recon: CDER Reveals 2016 Guidance Plans, NICE OKs BMS' Opdivo (22 January 2016)

Regulatory Recon: CDER Reveals 2016 Guidance Plans, NICE OKs BMS' Opdivo (22 January 2016)

Posted 22 January 2016 | By Michael Mezher 

Regulatory Recon: CDER Reveals 2016 Guidance Plans, NICE OKs BMS' Opdivo (22 January 2016)

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

In Focus: US

In Focus: International

  • Dialogue on drug policy reform in West Africa opens in Accra (PharmaAfrica)
  • Revised cleanroom standards incorporate best practices for contamination control (ISO)
  • NICE approves skin cancer drug in final draft guidance (OnMedica) (Bloomberg)
  • El Salvador urges against pregnancies until 2018 as Zika virus spreads (Reuters)

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US: Pharmaceuticals and Biotechnology

  • FDA Director's Corner Podcast: Looking back and moving forward in 2016 (FDA)
  • Glowing Tumors That Could Improve Cancer Surgery Are Getting Closer To Reality (Forbes)
  • What happened in biosimilars during 2015 (GaBI)
  • FDA Mulls Parameters for Allergy Therapies (MedpageToday)
  • Stem Cell Letter Could Signal New FDA Enforcement Trend (Law360-$)
  • CRISPR – does it hold the potential to revolutionise the pharmaceutical pipeline? (ABPI)
  • What Healthcare Leaders Should Do To Step Up: Part 1 (Forbes)

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

  • FDA Approves BOTOX (onabotulinumtoxinA) for the Treatment of Lower Limb Spasticity in Adults (Press)
  • Collegium Announces FDA Acceptance of IND Application for Abuse-Deterrent, Hydrocodone DETERx (Press)

US: Medical Devices

  • Questions Remain on How Device Cybersecurity Data Sharing Will Work (Focus)
  • Cranial Stimulators Split By FDA Into Class III For Depression And Class II For Anxiety/Insomnia (Gray Sheet-$)
  • 3 Things to Consider When Using Off-the Shelf Software (MDDI)
  • Medical device investments in Minnesota hit record level in 2015 (MassDevice)
  • Class 1 Device Recall Optisure HV lead (FDA)
  • Diabetes: Senseonics launches pivotal of 90-day implantable glucose monitor (MassDevice)
  • Top Boston Sci exec says more women are needed in device clinical trials (FierceMedicalDevices)
  • Humulin R U-500 KwikPen may improve glycemic control in people with severely insulin-resistant diabetes (Press)
  • Centinel Spine™ Announces the FDA Clearance and First Implantation of ALTOS (Press) (MassDevice)
  • LifeWatch One-Lead ECG Patch Receives 510(k) Clearance (MedDeviceOnline)
  • FDA Clears Integrated Table Motion For da Vinci Surgical System (MedDeviceOnline)

US: Assorted and Government

Upcoming Meetings and Events              


  • European Commission confirms CMDh recommendation: Benefit/risk profiles of ambroxol and bromhexine products are favorable (Press)
  • Bial Drug Tragedy: French Senate To Look Afresh At Clinical Trial Rules (SCRIP-$)


  • Roche and India's Glenmark reach truce over generic Tarceva (GaBI)
  • India issues alert to deter use of Roche's Avastin drug for eyes (Reuters) (Focus)
  • Medical devices industry welcomes Central govt's decision to hike duty on imported medical devices (PharmaBiz)
  • IDMA urges govt to reconsider its decision to hike fees for product registrations, manufacturing & product licences (PharmaBiz)


  • Repatha (Evolocumab) Approved As First PCSK9 Inhibitor In Japan For The Treatment Of High Cholesterol (Press)


  • Australian regulatory guidelines for sunscreens (ARGS) (TGA)

Other International

  • Novo aims to be ahead of pharma pack with Iran investment (Reuters)
  • Anti-hepatitis Harvoni to be released on Egyptian Market (Egypt Independent)
  • Ebola epidemic reveals gaps in research into diseases of poverty (EurActiv)

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

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

Categories: Recon, Regulatory News

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