Regulatory Focus™ > News Articles > Regulatory Recon: J&J Unit Fined $25M for Lack of Regulatory Compliance (11 March 2015)

Regulatory Recon: J&J Unit Fined $25M for Lack of Regulatory Compliance (11 March 2015)

Posted 11 March 2015 | By Alexander Gaffney, RAC

Regulatory Recon: J&J Unit Fined $25M for Lack of Regulatory Compliance (11 March 2015)

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

In Focus: US

In Focus: International

  • EMA Updates Brand, Generic, Biosimilar Guidelines to Require Inspection Details (FDAnews-$)
  • Ireland just accidentally legalised ecstasy, ketamine and magic mushrooms (Independent) (NPR)
  • Merck cancer drug is first approved under UK early access scheme (Reuters) (MHRA) (Press) (MHRA)
  • NHS plans to give patients quicker access to innovative medicines and medical technology (NHS) (Pharmafile)
  • EMA to Expand its Pharmacovigilance User Fees Later This Year (EMA)
  • Indian pricing authority chief shunted out? (SCRIP-$)
  • Four Priorities For Regulatory Convergence In Asia (PharmAsia-$)

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US: Pharmaceuticals and Biotechnology

  • Tylenol maker to pay $25 million for selling metal-contaminated drugs, lack of CAPA (Reuters) (Fierce) (DOJ) (WSJ-$) (Tan Sheet-$) (In-Pharma)
  • FDA ‘Expedited Review’ Would Shave Off Additional Month For Some ‘Breakthrough’ Products (Pink Sheet-$) (FDA MAPP) (BioCentury)
  • United Therapeutics wins FDA OK for rare kids' cancer drug (Fierce) (Pink Sheet-$) (Reuters) (FDA) (SCRIP-$) (Press)
  • Woodcock and Midthun: US can continue to lead in drug innovation (The Hill)
  • Woodcock on FDA's Approach to Preventing Prescription Opioid Abuse (JAMA)
  • The Generic Drug Proposed Rule – Use Codes and Other Issues (Lachman)
  • FDA to Require Labeling Change for Treanda (FDA)
  • US FDA expects more resources to fund biosimilar reviews and plant inspections (BioPharma Reporter)
  • Public Citizen Calls on FDA to Withdraw Guidance on Distribution of Risk Information (Public Citizen)
  • Montana "Right to Try" Bill Awaits Governor's Signature (Press)
  • Oklahoma House Unanimously Passed Right to Try Bill (Press)
  • Biosimilar Substitution Bill Introduced in North Carolina, Massachusetts (NC) (MA)
  • New FDA Policies on Antibiotic Use in Food Animal Production (Pew)
  • Janssen seeking to block Remicade biosimilar (BioCentury)
  • Reckitt Must Hand Over Nonprivileged Suboxone Docs To FTC (Law 360-$)
  • Ultra ZX LABS, L.L.C. Issues Voluntary Nationwide Recall of Ultra ZX Since It Contains Undeclared Sibutramine and Phenolphthalein (FDA)

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

  • Lpath to Submit Additional Data for Lpathomab Investigational New Drug Application (Press)
  • Zafgen's obesity drug hits the mark in orphan disease trial (Fierce)
  • Egalet Accelerates Development of Abuse-Deterrent Morphine Egalet-001 and Plans to File New Drug Application in the Fourth Quarter (Press)
  • Novo’s Tresiba reduces risk of hypoglycaemia (PMLive)
  • Breakthrough Therapy Designation for KLH-Conjugate Immunotherapy (Press)
  • Nightstar Receives U.S. and European Orphan Drug Designation for Gene Therapy to Treat Choroideremia (Press)

US: Pharmaceuticals and Biotechnology: General

  • Tyson continues effort to cut antibiotics from chicken production (Reuters)
  • Alternative way to pay for expensive drugs may be needed, analysis says (Press)
  • Pernix to Acquire Zohydro ER Franchise from Zogenix, Inc. (Press) (Xconomy)

US: Medical Devices

  • Medical Device ID Effort Hits Snag (WSJ-$)
  • Olympus Pushed Back at FDA on Cleaning Endoscopes to Kill Superbugs (Bloomberg)
  • FDA’s Hamburg Assures Senate Committee on Superbug Scope (MDDI)
  • Top Senate Dem calls for investigation of ‘superbug’ outbreaks (The Hill)
  • Do Medical Devices Without Wireless Need Cybersecurity? (MDDI)
  • Startup gets FDA nod for device to deter severe GERD condition (Fierce) (Press)
  • Tornier Announces U.S. FDA Clearance of Simpliciti Shoulder System (Press) (Mass Device)
  • High Risks And Rewards Found With Heart Valve Device From Edwards And Medtronic (Forbes) (JAMA)

US: Dietary Supplements

  • GNC: Independent, third party tests ‘conclusively’ confirm Herbal Plus products meet all requirements (NI-USA) (New Hope 360)
  • Hamburg Addresses Food Safety, Dietary Supplements in House Budget Hearing (NPI)

US: Assorted And Government

  • FDA admits 172 guidance documents linger in draft form (SCRIP-$) (BioCentury) (Pink Sheet-$)
  • Senate Begins Hearings on Potential FDA Reforms (Senate) (BioCentury) (FDA Hamburg)
  • FDA Commissioner Warns Against Lowering Safety, Effectiveness Standards (IHP-$)
  • Warren accuses GOP of chasing profits for medical companies (The Hill)
  • Blinding and Binning in Histopathology Methods in the Biomarker Qualification Process (PubMed)
  • Physician Payments Sunshine Act: Doug Brown of CMS Addresses Data Submission Issues in Latest Q&A (Policy and Medicine)

Upcoming Meetings

Ebola Outbreak

  • FDA Testimony on Responding to Threats After Ebola (FDA)

Europe

  • EMA Updates Brand, Generic, Biosimilar Guidelines to Require Inspection Details (FDAnews-$)
  • Ireland just accidentally legalised ecstasy, ketamine and magic mushrooms (Independent) (NPR)
  • Merck cancer drug is first approved under UK early access scheme (Reuters) (MHRA) (Press) (MHRA)
  • NHS plans to give patients quicker access to innovative medicines and medical technology (NHS) (Pharmafile)
  • EMA to Expand its Pharmacovigilance User Fees Later This Year (EMA)
  • The EMA at 20: Trust is the key (SCRIP-$)
  • The patenting of stem cells: an EU perspective (SCRIP-$)
  • Bayer submits Eylea for new treatment in EU (Reuters) (Press)
  • EU expands use of Novo's diabetes drug Tresiba (PharmaTimes)
  • Novartis' Xolair backed for NHS treatment of hives (PharmaTimes) (Press) (Pharmafile)
  • NICE supports NHS use of Roche's Gazyvaro in CLL (PharmaTimes) (Press) (Pharmafile) (SCRIP-$) (PMLive)
  • Data on MHRA's Authorization Performance (MHRA)
  • Pfizer Under Investigation for Possible Anticompetitive Practices in Spain (FDAnews-$)

India

  • Indian pricing authority chief shunted out? (SCRIP-$)
  • DTAB turns down commerce ministry's proposal to exempt multiple testing of APIs by 100% EOUs (PharmaBiz)
  • Key Provisions of India's Intellectual Property Appellate Board Struck Down as Unconstitutional (Spicy IP)
  • Brick-by-brick, India is restoring clinical trials 'parity' (SCRIP-$)

China

  • What Are Chinese Pharma CEOs Ranting About? (PharmAsia-$)

Australia

  • Homeopathy not effective for treating any condition, Australian report finds (Guardian)
  • Australian Public Assessment Report (AusPAR) guidance document (TGA)

Other International

  • Four Priorities For Regulatory Convergence In Asia (PharmAsia-$)
  • New IMDRF Presentations Posted (IMDRF)

Clinical Trials

  • Clinical trial results remain hidden when drugs are abandoned (AllTrials) (BMJ)

General Regulatory And Interesting Articles

  • Data Integrity Starts With User Access (GxP Lifeline)
  • The Science Behind A Crazy 6-Way Kidney Exchange (Wired)
  • 7 scary facts about antibiotic-resistant superbugs (Vox)
  • New test uses human stem cells to identify dangerous side effects of drugs (MNT)

Regulatory Reconnaissance #511 – 11 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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