Regulatory Focus™ > News Articles > Regulatory Reconnaissance: FDA Warns About High-Dose Acetaminophen (15 January 2013)

Regulatory Reconnaissance: FDA Warns About High-Dose Acetaminophen (15 January 2013)

Posted 15 January 2014 | By Alexander Gaffney, RAC

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know:

In Focus: US

In Focus: International

  • NICE issues draft AF guidelines (BioCentury)
  • German doctors urge govt to keep pharma benefits assessment (Pharma Times)
  • Shire seeks Vpriv approval in Japan (BioCentury)
  • Should journals stop publishing research funded by the drug industry? (BMJ)

US: Pharmaceuticals/Biotechnology

  • FDA: Acetaminophen doses over 325 mg might lead to liver damage (CNN) (SCRIP-$) (FDA) (Reuters) (FDA)
  • FDA panel backs Chelsea's Northera for rare disease (PMLive) (Pharma Times) (SCRIP-$) (Pink Sheet-$) (Pharma Letter-$) (BioCentury) (MedPage Today) (WSJ-$)
  • FDA panel likely to be rough ride for J&J/Janssen anticoagulant Xarelto (SCRIP-$) (BioCentury) (Pink Sheet-$) (Reuters) (Forbes)
  • Packaging Defect Leads Merck To Recall All Lots of Liptruzet In US (Forbes) (AP) (Law 360-$)
  • What's Merck Doing To Prevent More 'Missteps' With The FDA? (Forbes)
  • FDA Approves University of Texas, MD Anderson's Flurdeozyglucose F18 (FDA)
  • FDA Statement on "Brief Shortage" of Tamiflu (FDA)
  • Hepatitis C Virus (HCV): An Optimistic Future (Cato)
  • Virginia Bill Would Alter State Compounding Regulations (Virginia)
  • CDC, FDA studies link Merck and GSK rotavirus vaccines to bowel blockages (NBC) (NEJM) (AP) (Bloomberg) (Fierce)
  • Teva sees U.S. approval of three times weekly Copaxone soon (Reuters)
  • Weekend and Holiday ANDA Tentative (or Final) Approvals and 180-Day Exclusivity (FDA Law Blog)
  • Teva did not infringe OxyContin patents, Judge Rules (Reuters) (Law 360-$)
  • Allergan Stymies Generic Glaucoma Med In Patent Trial (Law 360-$)
  • Perrigo Announces FDA Final Approval for Generic Version of Vanos (Fluocinonide) Cream 0.1% (Press)
  • Roche Loses Last Shot At Booting NJ Accutane Judge (Law 360-$)
  • America's Unaccountable Generic Drug Industry (Center for Justice and Democracy)

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

  • Astellas and UMN Announce Summary Results in Phase III Clinical Trials of Seasonal Flu Vaccine ASP7374 (Press) (SCRIP-$)
  • Nektar's etirinotecan pegol passes Ph III interim efficacy analysis (Pharma Letter-$)
  • Sandoz starts late-stage trial of Humira biosimilar (DSN)
  • Iroko Pharmaceuticals Announces Acceptance for Filing of ZORVOLEX sNDA for the Treatment of Osteoarthritis Pain in Adults (Press)

US: Pharmaceuticals and Biotechnology: General

  • Facing Death-Drug Shortages, State Lawmaker Considers Firing Squads (National Journal)
  • As regulation of painkillers increases, Heroin returns as a drug of choice (Forbes)
  • No Easy Definition for 'Abusive' Prescribing (ProPublica)
  • Aetna tests whether drugs can help members lose weight (Modern Healthcare)

US: Medical Devices

  • Illumina introduces $1,000 human genome system (BioCentury) (Forbes) (MIT Tech Review)
  • Another InFuse Off-Label Win (D&D Law)
  • Medtronic's CEO says poor trial results push Symplicity's U.S. approval timeline 'off the table' (Fierce)
  • Intuitive Surgical CEO responds to hubbub over adverse events (Mass Device)
  • MediValve lands guidewire 510(k), CE Mark (Mass Device)
  • Varian Medical Systems Receives FDA 510(k) Clearance for its ProBeam Proton Therapy System (Press)
  • acWire for Precise Transcatheter Aortic Valve Replacement Gets FDA Green Light (MedGadget)
  • St. Jude's CEO is still betting on renal denervation, despite Medtronic's setback (Fierce)
  • Q&A on OSHA NRTL for AAMI ES 60601-1 3rd ed. + A1 (Eisner)
  • Tandem Diabetes Care Initiates Voluntary Recall for Specific Lots of Insulin Cartridges Used with t:slim Insulin Pump (FDA) (FDA)

US: Dietary Supplements

  • Industry applauds FDA's release of final version of liquid dietary supplements guidance (NI-USA)

US: Assorted And Government

  • Bipartisan Legislators Claim Vicotry In Restoring FDA User Fees (Press)
  • Omnibus Spending Bill - Section 474 on User Fees, Title VI on FDA (House)
  • Collecting Supplemental Information via Two-Phase Study Designs to Investigate Signals Arising from Medication Safety Surveillance Activities (Mini Sentinel)

Upcoming Meetings And Events

  • 14-15 January 2014: Nanomaterial Drug Products: Current Experience and Management of Potential Risks (FDA)
  • 15 January 2014: Cardiovascular and Renal Drugs Advisory Committee Meeting (FDA)
  • 16 January 2014: Cardiovascular and Renal Drugs Advisory Committee Meeting (FDA)
  • 28 January 2014: Allergenic Products Advisory Committee Meeting (FDA)
  • 28 January 2013: US State of the Union Address (White House)
  • 28-29 January 2013: Workshop - Strategies to Address Hemolytic Complications of Immune Globulin Infusions (FDA)
  • 29-30 January 2014: Science Advisory Board to the National Center for Toxicological Research Meeting (FDA)
  • 19 February 2014: FDA OAGS Small Business Outreach Vendor Fair (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)


  • NICE issues draft AF guidelines (BioCentury)
  • German doctors urge govt to keep pharma benefits assessment (Pharma Times)
  • SMC approves extensions for Herceptin and Velcade (SCRIP-$)


  • Shire seeks Vpriv approval in Japan (BioCentury)
  • Japan Companies, Government Join To Build Biotech Drug Industry (PharmAsia-$)
  • China FDA Cracks Down on Imports of Dietary Supplements: Part 2 (NPI)

General Regulatory And Interesting Articles

  • Should journals stop publishing research funded by the drug industry? (BMJ)
  • Swedish Researchers Raise Infant Safety Concerns About J & J's Tylenol (Forbes)
  • Seeking Clues to Obesity in Rare Hunger Disorder (NYTimes)
  • Managing Incidental Genomic Findings in Clinical Trials: Fulfillment of the Principle of Justice (PLoS)

Regulatory Reconnaissance #236 - 15 January 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.

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