Regulatory Focus™ > News Articles > Regulatory Recon: European Commission Transfers EMA Oversight to Pro-Industry Division (11 September

Regulatory Recon: European Commission Transfers EMA Oversight to Pro-Industry Division (11 September 2014)

Posted 11 September 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: European Commission Transfers EMA Oversight to Pro-Industry Division (11 September 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 here.

In Focus: US

In Focus: International

  • New EU president moves regulation of medicines to industry department (AllTrials) (EC) (Clinica) (SCRIP-$)
  • Sun Pharma shares dip on surprise audit by USFDA at Halol plant (Business Line) (Business Standard) (NDTV)
  • GSK China consumer healthcare unit linked to DOJ probe in 2012 (Reuters)
  • Report: Canadians kept in dark about defective drugs (The Star)
  • Ebola highlights slow progress in war on tropical diseases (Reuters)

US: Pharmaceuticals and Biotechnology

  • Obesity Drug Contrave (Finally) Obtains FDA Approval (NYTimes) (FDA) (Press) (SCRIP-$) (BioCentury) (Fierce) (Xconomy) (Pharmafile) (Forbes)
  • Medivation Prostate Cancer Drug Xtandi Secures Expanded FDA Label (The Street) (Press) (SCRIP-$) (BioCentury) (Pharma Times) (Pharmafile) (Press) (Reuters)
  • FDA Advisory Panel Offers Cautious Support For Polypill (Forbes)
  • NRDC Urges 2nd Circ. To Rehear Livestock Antibiotic Suit (Law 360-$)
  • Man tied to deadly 2012 U.S. meningitis outbreak due in court in Boston (Reuters)
  • Industry groups take issue with FDA draft guidance on outsourcing facilities (In-Pharma)
  • Company Wants FDA to Change OTC Susncreen Water Resistance Testing Requirements (FDA)
  • Otsuka Wants FDA Not to Accept Alkermes' NDA for Injectable Antipsychotic (FDA)
  • Duchesney Petitions FDA to Heighten Standards for Diclegis Generics (FDA)
  • Zydus Petitions FDA to Amend Mercapturine Tablet Listing in Orange Book (FDA)
  • Current FDA's Warning Letters on IT Topics - Part 2: Finished Medicinal Products and APIs (ECA)
  • Pain Physician Society Wants FDA to Withdrawn Warning on Epidural Corticosteroid Injections (FDA)
  • Commentary Regarding new USP Chapters <787> and <1787> for Particulate Matter Guidance (ECA)
  • AHPA Publishes Recommendations for Regulators on Cannabis (NPI)
  • J&J Looks To Expand Consumer Business After Consent Decree Obligations End (Tan Sheet-$)
  • Lannett Receives FDA Approval for Oxycodone Hydrochloride Oral Solution (Press)

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

  • AbbVie Announces Pivotal Phase 3 Data Evaluating Efficacy of HUMIRA (adalimumab) in Patients with Hidradenitis Suppurativa (HS), a Chronic Inflammatory Skin Disease (Press)
  • First Phase III data for Mimetogen's dry eye compound (BioCentury)
  • PLEGRIDY (Peginterferon Beta-1a) Two-Year Data Confirm Maintenance of Efficacy and Safety in Multiple Sclerosis Patients (Press)
  • Antibiotics Do Not Shorten TB Treatment, Trial Finds (DD&D)
  • Roche abandons another Fragile X R&D program after PhII trials flunk out (Fierce)
  • New Data from ENDORSE Show Positive Results Continued over Five Years with TECFIDERA (Dimethyl Fumarate) in a Wide Range of Multiple Sclerosis Patients (Press)

US: Pharmaceuticals and Biotechnology: General

  • R&D pioneer tackles the next hurdle in gene therapy: Paying for $1M-plus drugs (Fierce)
  • On Drug Price Hikes and Consciences (In the Pipeline)

US: Medical Devices

  • FDA Clears Wearable Parkinson's Diagnosis Device KinetiGraph (Mass Device) (Press) (Fierce)
  • Medtronic NC Euphora(TM) Coronary Balloon Receives FDA Clearance (Press)
  • "Buzzy" Pain Device Obtains FDA Clearance (Press)
  • No Evidence Supporting Newer Joint Replacement Devices (MedScape)
  • AdvaMedDx Supports FDA Oversight Of LDTs Risk-Based Approach Will Support Innovation, Patient Safety (MedDevice Online)
  • Republicans, Labs Call For Economic Analysis Of FDA's LDT Framework (IHP-$)
  • ACLA head makes case against FDA LDT regulation to Congress  (Fierce)
  • Otoharmonics Levo Tinnitus Treatment System Cleared by FDA (MedGadget)
  • IMRIS neurosurgical HFD rocker arm receives FDA clearance (Press)

US: Dietary Supplements

  • USP and Dietary Supplements ... A Return to Our Roots (USP)

US: Assorted And Government

  • House Republicans Say Increased NIH, FDA Funding Off Table For Medical Innovation Bill (IHP-$)
  • 2014 Edition Release 2 Electronic Health Record (EHR) Certification Criteria and the ONC HIT Certification Program; Regulatory Flexibilities, Improvements, and Enhanced Health Information Exchange  (HHS) (Forbes)
  • Biz group: Cost of fed regs eclipses $2 trillion (The Hill) (CPR)

Upcoming Meetings

Ebola Outbreak

Europe

  • New EU president moves regulation of medicines to industry department (AllTrials) (EC) (Clinica) (SCRIP-$)
  • European Industry Group Joins Device Clinical-Study Standard Efforts (Gray Sheet-$)

India

China

  • GSK China consumer healthcare unit linked to DOJ probe in 2012 (Reuters)
  • China Drug Maker Cleared As First To Make Generic Viagra (PharmAsia-$)

Japan

  • Japan Committee Recommends 6 Drugs Including Pfizer’s Bosulif (PharmAsia-$)

Canada

  • Report: Canadians kept in dark about defective drugs (The Star)
  • Health Canada: We do not enforce the law when Canadians poison Americans (S4S)
  • Health apps could put patients at risk, regulators say (Toronto Sun)

Australia

  • Regulation of internationally controlled drugs moves to the TGA (TGA)
  • Medicines scheduling secretariat has moved to the TGA (TGA)

Clinical Trials

  • Aiming at Target Profiles to Create Better Patient Experiences (Lilly)

General Regulatory And Interesting Articles

  • Ebola highlights slow progress in war on tropical diseases (Reuters)
  • What is the difference between OOS / OOE / OOT? (ECA)
  • Needle that breaks after first use to be adopted in WHO mandate to curb infection spread (MedCity News)

Regulatory Reconnaissance #397 – 11 September 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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