Regulatory Focus™ > News Articles > Regulatory Recon: EMA Launching Generic Drug Regulation Pilot Program (7 August 2014)

Regulatory Recon: EMA Launching Generic Drug Regulation Pilot Program (7 August 2014)

Posted 07 August 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: EMA Launching Generic Drug Regulation Pilot Program (7 August 2014)

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

This fall, regulatory professionals from across the globe will come together to learn, connect and share at the Regulatory Affairs Professionals Society’s 2014 RAPS: The Regulatory Convergence, 27 September-1 October, Austin, TX.  Register by 29 August 2014 to receive the lowest rate.

In Focus: US

  • FDA approves The Medicines Co's Orbactiv to treat skin infections (FDA) (BioCentury) (Reuters) (Press) (Pharma Times) (SCRIP-$)
  • Pfizer Reaches $35 Million Settlement Over Rapamune Marketing (WSJ-$) (Pharma Times)
  • Biosimilar Naming Debate Expands As Groups Jump In, Push Shared Names (IHP-$)
  • Medtech insiders respond to FDA's 510(k) split-predicate ban (Mass Device)
  • Will FDA Regulate Your Mobile Medical App? (MDDI)
  • FDA 2015 Budget Likely To Stay At Current Levels, Supporters Predict (Gray Sheet-$)

In Focus: International

  • Europe to boost cooperation with international partners on generics (EMA)
  • Commission Updates EU Medical Devices Borderline Manual (Inside Medical Devices)
  • DCGI sets up Independent Expert Committee for examination of reports of SAEs occurred during trials (PharmaBiz)
  • AdvaMed Pushes For Separate Indian Medical Devices Law (PharmAsia-$)
  • WHO consults ethics experts on wider use of experimental Ebola drugs (Reuters) (WHO) (WaPo)

US: Pharmaceuticals and Biotechnology

  • FDA approves The Medicines Co's Orbactiv to treat skin infections (FDA) (BioCentury) (Reuters) (Press) (Pharma Times) (SCRIP-$)
  • Pfizer Reaches $35 Million Settlement Over Rapamune Marketing (WSJ-$) (Pharma Times)
  • Biosimilar Naming Debate Expands As Groups Jump In, Push Shared Names (IHP-$)
  • Report Calls for End to Overuse of Antibiotics in Livestock Production (US PIRG)
  • Zydus Cadila gets United States Food and Drug Administration nod for kidney stones tablets (India Times)
  • Why a bigger deal hasn't been made of the world's first approval of a Duchenne drug (BioFlash)
  • Overview of PEPFAR (FDA)

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

  • FDA Grants Fast Track Designation to CTI BioPharma's Pacritinib, a Novel JAK2 Inhibitor for the Treatment of Myelofibrosis (Press)
  • Egalet reports mixed data for abuse-deterrent morphine (BioCentury)
  • Emergent BioSolutions Submits Biologics License Application to FDA for Anthrax Immune Globulin Intravenous (Human) (Press)
  • BDSI Reports 'Encouraging' Results from Phase 3 Analysis (Press)

US: Pharmaceuticals and Biotechnology: General

  • PTO too broad in guidance on natural products: PhRMA, BIO  (BioCentury) (BIO)
  • PCORI Issues New Calls for Research Proposals Totaling $76 Million (PCORI)
  • Cambridge firm’s Ebola drug carries hope, risk (Boston Globe) (The Street)

US: Medical Devices

  • Medtech insiders respond to FDA's 510(k) split-predicate ban (Mass Device)
  • Will FDA Regulate Your Mobile Medical App? (MDDI)
  • Op-Ed: FDA Slowing Health App Innovation (WSJ-$)
  • How Medical Device Identification Supports High-Quality Healthcare (Pew)
  • Boston Scientific reveals federal probe of BridgePoint medical sales (Mass Device)
  • Supply Chain Security Breaches Increase Regulatory Scrutiny, Says Dow Corning (Pharma Manufacturing)

US: Assorted And Government

  • FDA 2015 Budget Likely To Stay At Current Levels, Supporters Predict (Gray Sheet-$)
  • FDA Weekly Enforcement Report (FDA)
  • Docs Urge CMS to Postpone Deadline for ‘Sunshine’ Data Disclosures (Pharmalot)

Europe

  • Europe to boost cooperation with international partners on generics (EMA)
  • Concept paper on transferring quality control methods validated in collaborative trials to a product / laboratory specific context (EMA)
  • Concept paper on use of aminoglycosides in animals in the European Union: Development of resistance and impact on human and animal health (EMA)
  • Commission Updates EU Medical Devices Borderline Manual (Inside Medical Devices)
  • EC approves Octapharma's Nuwiq (BioCentury)
  • European Medicines Agency Accepts Application Seeking New Indication For Prevenar 13®1 For Prevention Of Pneumococcal Pneumonia In Adults (Press)

India

  • DCGI sets up Independent Expert Committee for examination of reports of SAEs occurred during trials (PharmaBiz)
  • AdvaMed Pushes For Separate Indian Medical Devices Law (PharmAsia-$)
  • IPC releases guidance document for PvPI in lines with WHO-NRA recommendation (PharmaBiz)

China

  • CFDA Site Inspection Moves Hisun’s Biosimilar Enbrel Forward (PharmAsia-$)

Canada

  • Canada seeks patient input for orphan drug reviews (BioCentury)
  • Bavarian Nordic to supply Canada with 46K smallpox vaccines (Reuters)

Other International

  • WHO consults ethics experts on wider use of experimental Ebola drugs (Reuters) (WHO) (WaPo)
  • AHWP Seeking New Committee Co-Chairs (AHWP)
  • Russia Testing Preclinical Ebola Vaccine (PharmAsia-$)

Clinical Trials

  • 5 Ways Smartphones Can Improve Clinical Trials (MedGadget)

General Regulatory And Interesting Articles

  • Breathing on Anti-Counterfeit Drug Labels Reveal Hidden Images (Mashable)
  • Experimental non-invasive tests detect rare brain disease (Reuters)
  • Study Shows Third Gene as Indicator for Breast Cancer (NYTimes) (Reuters)
  • Weight Watchers, Qsymia come out on top in analysis of cost effective weight loss programs (MedCity News)
  • Is PrEP Cost-Effective? (CGDev)
  • Exposure to inflammatory bowel disease drugs could increase leukemia risk (Press)

Regulatory Reconnaissance #374 – 7 August 2014

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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