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Regulatory News
26 February 2013
by Alexander Gaffney, RAC

Regulatory Reconnaissance (26 February 2013)

Good morning, and welcome to another edition of Regulatory Reconnaissance. The sequester comes into effect on Friday, and Steven Grossman of the group Alliance for a Stronger FDA says FDA stands to lose about $210M from its budget because of it.

In the US, FDA approves Stivarga for GI tumors and a new cattle drug, industry groups are panning parts of a CDER draft guidance on electronic submissions, and Medtronic has won expanded approval for its Resolute Integrity stent. Abroad, the EC meets today to start working on a medical device regulatory framework, VICH is out with new guidelines, India's trial approvals rate has fallen by 50% in two years, and MHRA is warning of a risk of fracture associated with Amgen's bone drug Prolia.

Five in Focus:

  1. Meeting Today on Future Regulation of Medical Devices and IVDS in the EU (Presentations)
  2. FDA approves Stivarga for advanced gastrointestinal stromal tumors (FDA)
  3. Medtronic wins expanded FDA approval for diabetic-friendly Resolute Integrity stent (Mass Device) (Fierce Medical Devices) (Medtronic)
  4. Clinical Trials Approvals in India Plunge from 529 in 2010 to 253 in 2012 (PharmaBiz)
  5. Blood Drug Woes Could Weigh on FDA and its Approval of New, Copycat Biologic Medicines(Forbes)

US

Sequester

Pharmaceuticals/Biologics

  • FDA approves Stivarga for advanced gastrointestinal stromal tumors (FDA)
  • FDA Approves Drug to Assist with Cattle Breeding Regimens (FDA)
  • Reckitt Benckiser faces inquiry over move to block heroin substitutes (The Guardian)
  • PhRMA, BIO, Gilead, Regeneron all Submit Comments on CDER Draft Guidance for Industry Providing Submissions in Electronic Format (Summary Level Clinical Site Data for CDER Inspection Planning) (PhRMA) (BIO) (Gilead Sciences) (Regeneron Pharmaceuticals)
  • Report: FDA Has Transmitted ADUFA and AGDUFA User Fee Goal Letters and Legislative Text to Congress (FDA Law Blog)
  • Dynavax regroups after FDA turns thumbs down on hep B vaccine Heplisav (Fierce Biotech) (WSJ)
  • Sydney Wolfe's 7-Year Drug Rule/Itch: Don't Prescribe or Imbibe Any New Drug for First Seven Years After FDA Approval (Pharma Marketing Blog)
  • 'System Worked' in Omontys Recall (Medpage Today)
  • Pfizer Wants Court To Rehear Generic Labeling Case And Avoid Tort Hell (Forbes)
  • Medwatch: Maxiloss Weight Advanced Softgels: Recall - Undeclared Drug Ingredient (FDA) (Recall)
  • What Happens When Pharma Advertises? (Medical Progress Today)
  • Meetings: Seventh Annual DIA/FDA Statistics Forum, 2013 (FDA)
  • PhRMA skeptical of limited-use pathway (BioCentury) ($)
  • Blood Drug Woes Could Weigh on FDA and its Approval of New, Copycat Biologic Medicines(Forbes)
  • Pharmacy trade group shifts position on federal oversight (Washington Post) (The Pink Sheet)

Medical Devices

  • Medtronic wins expanded FDA approval for diabetic-friendly Resolute Integrity stent (Mass Device) (Fierce Medical Devices) (Medtronic)
  • J&J To Pay $3.4M For Defective Vaginal Mesh Implant (Pharmalot) (Philly Pharma)
  • Biotronik nabs FDA nod for single-lead ICD (Fierce Medical Devices)
  • Study: 1 in 10 recalled St. Jude Medical Riata lead coatings fail within 6 years (Mass Device)
  • Recall (Class 1): Lumenis Limited, Lumenis VersaCut Tissue Morcellator (FDA)
  • In 5 Years, Medtech Firms Will Outsource Design, Legal, and Regulatory Services Over Manufacturing, Report Finds (MD+DI)

Assorted

  • Monsanto V. Bowman: Could This Court Case Affect Stem Cell Research? (BioCenturyTV)
  • Former Surgeon General C. Everett Koop dies at age 96 (CNN) (NYTimes)
  • Congressman Asks FDA to Take a Look at Marijuana (ForexTV)
  • Withdrawn: Guidance on the Labeling of Certain Uses of Lecithin Derived From Soy Under Section 403(w) of the FD&C Act (FDA)
  • National Toxicology Program Preparing to Release Draft Approach and Case Study Protocols for Literature-Based Assessments (NIH)
  • NIH rare disease event to raise awareness, encourage research collaborations (NIH)

International

  • Meeting Today on Future Regulation of Medical Devices and IVDS in the EU (Presentations)
  • VICH Adopts Guidelines 34, 35, 50 and 51 at 19 February 2013 Meting) (VICH)
  • Clinical Trials Approvals in India Plunge from 529 in 2010 to 253 in 2012 (PharmaBiz)
  • India Opened 620 Investigations Against Objectionable Advertisements in Last Two Years (PharmaBiz)
  • Compulsory License Court Case Gets a Date: 4 March 2013 (PharmaBiz)
  • MHRA warns of fracture risk with Amgen's Prolia (Pharma Times)
  • The European Commission is out with a new search engine for its pharmaceutical legislations (EC)
  • Canada Adopts Draft ICH M7 Guideline (Health Canada)
  • Device manufacturers and EU lawmakers meet to strengthen regulations amid recalls, says analyst (Medical Design)
  • Draft regulations on device classification published in Peru (Mass Device)
  • In Shift, Australia Would End R&D Tax Breaks for Big Firms to Fund New Innovation Networks(Science Insider)
  • Nigeria Launches 'NTD Master Plan' (Kaiser)
  • Singapore's HSA Alerts Public to Adulterated Health Products Purchased Overseas That Have Caused Serious Adverse Reactions (HSA)
  • India's DCGI: Stop cosmetics testing on animals (BioSpectrum)

Interesting

  • Transparency demands could threaten early trial investment (Pharma Times)
  • Are Women Being Prescribed too Many Pharmaceuticals During Pregnancy? (NYTimes)
  • Geneva scientist builds low-cost fake drug detector (BioSpectrum)
  • Dx blood test for suicide risk a year from clinical trials (Fierce Medical Devices)

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 or @AlecGaffney and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance.

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