Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Labeling Rule May Fuel Lawsuits Against Branded Drugs (14 January 2013)

Regulatory Reconnaissance: Labeling Rule May Fuel Lawsuits Against Branded Drugs (14 January 2013)

Posted 14 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: news@raps.org.

In Focus: US

  • In California, New Stewardship Responsibilities, Costs Proposed for Drug and Needle Manufacturers (CA Healthline)
  • FDA Generic Labeling Reg Could Fuel Suits Against Brands As Well (Pink Sheet-$)
  • Oral Arguments Set Over J&J Appeal of $1B Fine (AP)
  • Industry Weighs in on Hepatitis C Drug Development Guidance (FDA)
  • GSK's Tafinlar named as FDA breakthrough therapy for lung cancer (Reuters) (Press) (Pharma Times)
  • Thoratec responds to NEJM blood clot report (Mass Device)

In Focus: International

  • Big firms to discuss introduction of biosimilar substitution in France (SCRIP-$)
  • Wockhardt's regulatory unit gets new head  (BioSpectrum) (India Times)
  • China FDA Cracks Down on Supplement Imports (NPI)

US: Pharmaceuticals/Biotechnology

  • In California, New Stewardship Responsibilities, Costs Proposed for Drug and Needle Manufacturers (CA Healthline)
  • FDA Generic Labeling Reg Could Fuel Suits Against Brands As Well (Pink Sheet-$)
  • Oral Arguments Set Over J&J Appeal of $1B Fine (AP)
  • Cancer Therapies: The Breakthrough Era (RPM Report-$)
  • Industry Weighs in on Hepatitis C Drug Development Guidance (FDA)
  • Biosimilar Developers Prepare For Applications In 2014, Approvals Mid Decade (IHP-$)
  • Compounding Questions Persist As Industry Enters Implementation Phase (IHP-$)
  • FDA Approves Apotex's Generic Candesartan Cilexetil, Teva's Generic Pioglitazone HCl, and Tentatively Approves Actavis' Generic Pregabalin (FDA)
  • FDA Should Assume Authority Over Human Cloning (Law 360-$)
  • Pfizer Faces Whistleblower Suit Over Lipitor Marketing (Law 360-$)
  • Denmark's Novo Nordisk sued in U.S. over generic Prandin (Reuters)
  • Meetings: Pediatric Advisory Committee (FDA)

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

  • GSK's Tafinlar named as FDA breakthrough therapy for lung cancer (Reuters) (Press) (Pharma Times)
  • J.P. Morgan Notebook: Monday, January 13 (Pink Sheet-$)
  • Merck starts roll-out of BLA for MK-3475 (Pharma Letter-$) (PharmaTimes) (PMLive) (SCRIP-$) (BioCentury)
  • Fulyzaq (crofelemer) 125 mg Delayed-Release Tablets Significantly Improves Noninfectious Diarrhea in Adult Patients Living with HIV on ART Therapy (Press)
  • ZS Pharma's ion trap candidate jumps next Ph III hurdle (SCRIP-$)
  • Gilead's idelalisib gets standard FDA review (SCRIP-$) (BioCentury)

US: Pharmaceuticals and Biotechnology: General

  • The case for an antibiotics tax (Washington Post)
  • Sen. Brown Urges FDA To Continue To Help Keep Manufacturing At Ben Venue's Bedford Lab To Fight Shortages Of Lifesaving Drugs (Senate)

US: Medical Devices

  • Thoratec responds to NEJM blood clot report (Mass Device)
  • FDA OKs new trial for Edwards Lifesciences heart valve (Mass Device) (Fierce)
  • FDA clears second EarlySense bed sensor for the home (MobiHealthNews)
  • Alere HomeLink Receives FDA Clearance for Over-the-Counter Use (Press)

US: Assorted And Government

  • US Food and Drug Administration documents can provide unpublished evidence relevant to systematic reviews. (NCBI)
  • Health industry to test cybersecurity resilience (Fierce) (Press)

Upcoming Meetings And Events

  • 14 January 2014: Sixth Annual Sentinel Initiative Public Workshop (FDA)
  • 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)

Europe

  • Big firms to discuss introduction of biosimilar substitution in France (SCRIP-$)
  • GSK makes imaging deal to help drive drug development (Pharmafile)
  • French Court Finds Notified Body Liable in Breast Implants Scandal (Inside Medical Devices)

Asia

  • Wockhardt's regulatory unit gets new head  (BioSpectrum) (India Times)
  • China FDA Cracks Down on Supplement Imports (NPI)
  • India Rejects Wockhardt Appeals For Price Reviews For Three Drugs (PharmAsia-$)

General Regulatory And Interesting Articles

  • Searching Genes to Avoid Medical Side Effects (WSJ-$)
  • New Recommendations for Research with Human Subjects Who Lack Consent Capacity (Bioethics Forum)
  • Nature Editorial: Share the Drug Data (Nature)
  • Healthcare Triage: Antibiotic Myths (TIE)
  • Feeling mad? New devices can sense your mood and tell - or even text - others (Washington Post)

Regulatory Reconnaissance #235 - 14 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.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.


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