Regulatory Focus™ > News Articles > Regulatory Recon: Europe's New Five-Year Drug Regulatory Strategy (31 March 2015)

Regulatory Recon: Europe's New Five-Year Drug Regulatory Strategy (31 March 2015)

Posted 31 March 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: Europe's New Five-Year Drug Regulatory Strategy (31 March 2015)

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

In Focus: US

  • Feraheme Label Updated with New Warnings, Contraindication (MPR) (FDA) (FDA)
  • Testosterone Label Changes Could Make Advertising More Challenging (Pink Sheet-$)
  • High Court Won't Hear Pliva's Generic Preemption Case (Law 360-$)
  • More States Demand Notification to Use Biosimilar Drugs (Pew)
  • How BARDA Is Helping Speed Up Drug Development/Manufacture (LifeSciLeader)
  • FDA expands use of CoreValve System for aortic “valve-in-valve” replacement (FDA) (Mass Device)
  • Hamburg: Neither U.S. Nor EU Device Regulation Has It Completely Right (Gray Sheet-$)
  • ONC Adds UDIs To Certification Criteria In Health IT Proposed Rule (IHP-$)

In Focus: International

  • EMA Releases a New Five-Year Strategy Document (EMA) (Strategy)
  • Appeals under way as EC and EMA reject ruling that ousted Rasi (SCRIP-$)
  • France's ANSM Launches Investigation Into Potential Ethics Breach (ANSM)
  • Questions and answers on 'Guideline on the environmental risk assessment of medicinal products for human use' (EMA)
  • New EMA User Fees Come Into Effect Tomorrow (EMA)
  • Japan's health ministry moves to revamp OTC drug rules to cut costs (Fierce)

Learn About--and Help Shape--FDA's Draft Combo Products GMP Guidance

  • When it comes to combination products, more regulations can mean more difficulties for regulatory professionals. That's why we've teamed up with the Combination Products Coalition (CPC) to offer a full day interactive program focused on FDA's newest draft guidance on Good Manufacturing Practices (GMPs) for combination products. Learn from FDA experts and industry veterans in this unique experience that will help agency regulators to shape and clarify the final guidance document. Register for the 1 April 2015 program here.

US: Pharmaceuticals and Biotechnology

  • Feraheme Label Updated with New Warnings, Contraindication (MPR) (FDA) (FDA)
  • Testosterone Label Changes Could Make Advertising More Challenging (Pink Sheet-$)
  • High Court Won't Hear Pliva's Generic Preemption Case (Law 360-$)
  • More Thoughts on the PATIENT Act (FDA Law Blog)
  • More States Demand Notification to Use Biosimilar Drugs (Pew)
  • Open Payments Submissions Due Today, March 31 (Policy and Medicine)
  • BIO Throws Urges Passage of Georgia Biosimilar Notification Bill (BIO) (BioPharma Reporter)
  • DOJ Investigation Into Generic Pharma: You Could Be Next (Law 360-$)
  • Pew Trusts Throws Support Behind PATH Act for Antibiotics (Pew)
  • FDA Can't Revoke Ranbaxy's Drug Approvals, DC Circ. Told (Law 360-$)
  • J&J, Glaxo settle U.S. lawsuit over allergy ads (Reuters)
  • Ranbaxy Can’t Nix Glass-Tainted Pill Class Action (Law 360-$)
  • Oregon Right to Try bill passes House committee (Statesman Journal)
  • Massachusetts ‘Right-to-Try’ Bill Introduced (Thompson's)
  • Novartis announces FDA approval for Jadenu to simplify treatment administration for patients with chronic iron overload (Press) (SCRIP-$)
  • Brilinta Receives FDA Approval for New Administration Option (Press)
  • Pharmaceutical Compliance: A Conversation with Chuck Bates (USP)
  • FDA panelist confirms conflict of interest following Sarepta drug discussions (BioFlash)
  • Joplin physician pays restitution in FDA case (Joplin Globe)
  • Washington, D.C., Area Pharmacist Indicted and Arrested on Charges Involving Illegal Pharmaceutical Shipments (DOJ)

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

  • Speedy US review for Amgen's Kyprolis (PharmaTimes) (Press)
  • BioDelivery tanks as its pain gel comes up short in Phase III (Fierce) (SCRIP-$) (BioCentury)
  • Shionogi's naldemedine meets Phase III endpoints for opioid-induced constipation (Fierce) (SCRIP-$)
  • Chi-Med's fruquintinib meets in mCRC Phase II (BioCentury)

US: Pharmaceuticals and Biotechnology: General

  • How BARDA Is Helping Speed Up Drug Development/Manufacture (LifeSciLeader)
  • UnitedHealth Bulks Up For Prescription Drug Cost Battle (AP) (Pharmalot) (Forbes)
  • US pharmacist group moves to block execution drugs (AP) (Pharmalot)
  • This drug, banned in Europe, Russia and China, may be in your lunch (Reuters)

US: Medical Devices

  • FDA expands use of CoreValve System for aortic “valve-in-valve” replacement (FDA) (Mass Device)
  • Hamburg: Neither U.S. Nor EU Device Regulation Has It Completely Right (Gray Sheet-$)
  • ONC Adds UDIs To Certification Criteria In Health IT Proposed Rule (IHP-$)
  • From Idea to Market Release: Your Quick Guide to FDA Design Controls (MedCityNews)
  • Quality Spending Increasing in Medtech (MDDI)
  • FDA clears iPad app for pre-operative surgical planning (MobiHealthNews)
  • VA begins clinical trial of mobile app PTSD Coach (MobiHealthNews)

US: Dietary Supplements

  • CRN: GNC, NY AG agreement a 'disservice to consumers' (DSN) (NI-USA)
  • GNC Deal May Push Retailers To Boost Supplement Testing (Law 360-$)
  • First Seven FDA Warning Letters for Supplement Labels in 2015 (Dietary Supplement Experts)
  • Manufacturing Dietary Supplements to a High Level of Quality at a Low Price (NPI)
  • Fish Oil Claims Not Supported by Research (NYTimes)

US: Assorted And Government

  • NIH forms team of experts to chart course for the President’s Precision Medicine Initiative research network (NIH)
  • Senate Working Group Reaches Out To FDA, NIH In Its 'Alternative' Cures Initiative (IHP-$)

Upcoming Meetings and Events

Ebola Outbreak

  • BioCryst Pharma wins federal contract to continue making Ebola drug (Reuters)

Europe

  • EMA Releases a New Five-Year Strategy Document (EMA) (Strategy)
  • Appeals under way as EC and EMA reject ruling that ousted Rasi (SCRIP-$)
  • France's ANSM Launches Investigation Into Potential Ethics Breach (ANSM)
  • Questions and answers on 'Guideline on the environmental risk assessment of medicinal products for human use' (EMA)
  • New EMA User Fees Come Into Effect Tomorrow (EMA)
  • Pfizer Thwarts UK Docs From Prescribing a Drug Over Patent Dispute (Pharmalot) (Fierce)
  • Novartis cancer pill makes it onto UK early access list (PMLIve)
  • European Medicines Agency Commences Review of CSL Behring's Regulatory Submission for rIX-FP for Hemophilia B Patients (Press)
  • EC Approves Orexigen’s Mysimba (EC)

India

  • Compulsory licensing hit India’s image: Hetero Pharma (India Times)

Japan

  • Japan's health ministry moves to revamp OTC drug rules to cut costs (Fierce)
  • Medtronic Announces Japanese Regulatory Approval of CoreValve System (Press)
  • Genzyme’s Cerdelga (eliglustat) Capsules Approved in Japan (Press)

China

  • China Online Drug Sellers Blossom Despite Regulatory Hold (PharmAsia-$)

Canada

  • International Generic Drug Regulators Programme (IGDRP) Information Sharing Pilot (Health Canada)
  • Health Canada issues “stronger, clearer” warnings about suicide risks linked to ADHD drugs (Toronto Star)

Australia

  • Half-yearly performance reports (TGA)

Other International

  • Harmonized Post-Approval Changes: A Vaccine For Global Drug Shortages (LifeSciLeader)

Clinical Trials

  • Quintiles, Quest to combine clinical trial lab operations (Reuters) (Press)
  • What Is SEND? A Brief Introduction To The Standard For Exchange Of Nonclinical Data (MedDeviceOnline)

General Regulatory And Interesting Articles

  • The Search for a Better Definition of Pain (WSJ-$)
  • Study: Patients Are Modifying Drug Dosages (Press)
  • Fish don’t want birth control, but scientists say they get it from your pill (Washington Post)
  • Pfizer is pharma’s biggest advertiser (Pharmafile)

Regulatory Reconnaissance #525 – 31 March 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 @AlecGaffney 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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