Regulatory Focus™ > News Articles > Regulatory Recon: After 6 Years on the Job, FDA Commissioner Hamburg to Resign (5 February 2015)

Regulatory Recon: After 6 Years on the Job, FDA Commissioner Hamburg to Resign (5 February 2015)

Posted 05 February 2015 | By Alexander Gaffney, RAC

Regulatory Recon: After 6 Years on the Job, FDA Commissioner Hamburg to Resign (5 February 2015)

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

In Focus: US

  • Margaret Hamburg to Resign Next Month (Reuters)
  • Merck’s HCV Combo Will Test FDA’s ‘Breakthrough’ Rescission Process (Pink Sheet-$)
  • Mining the Bowels of the Orange Book: What Do the Data Reveal? (FDA Law Blog)
  • How Can We Better Measure Biomedical Innovation? (Brookings)
  • Public Citizen: Training Medical Devices Need to Have More Explicit Warnings on Labels (HuffPo)
  • Characteristics of Pivotal Trials and FDA Review of Innovative Devices (PubMed)
  • Sen. Warren goes to bat for medical device industry (TIME)
  • Senators ask FDA for national investigation of dietary supplements (The Hill)

In Focus: International

  • Ebola Drug Aids Some in a Study in West Africa (NYTimes) (Reuters)
  • Review calls for global fund to fight dangerous superbugs (Pharmafile) (PharmaTimes) (Reuters)
  • Think you’re on track for 2018 EU serialisation? No you’re not (Outsourcing Pharma)
  • India seeks to move barcode tracking on drugs further upstream (Fierce)
  • New China FDA chief signals pricing reform a priority (BioCentury)

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US: Pharmaceuticals and Biotechnology

  • Merck’s HCV Combo Will Test FDA’s ‘Breakthrough’ Rescission Process (Pink Sheet-$)
  • Pitts, Pallone and Green Re-Introduce Legislation to Speed New Therapies (House)
  • Mining the Bowels of the Orange Book: What Do the Data Reveal? (FDA Law Blog)
  • FDA-Funded Study Shows Potential for Improvement in iPledge Program (Futurity)
  • Wockhardt says resolved US facility compliance issues (DNAindia)
  • Generics Seek Stronger Proscriptions in REMS Compliance Letter Guidance (FDAnews-$)
  • FDA Mulls Clearing Abilify Rival Based On Single Trial (Law 360-$)
  • Live Webcast Today on the Sentinel Initiative (Brookings)
  • Biosimilars: the need, the challenge, the future: the FDA perspective (Nature)
  • How We Communicate Matters – Comparing Communications Vehicles and Regulatory Enforcement (Eye on FDA)
  • Warning Letters Address Drug Claims Made for Products Marketed as Cosmetics (FDA)
  • Rock Creek Warning Letter Closed Out (SEC)
  • ALS Advocates Push FDA to Approve Alzheimer's Drug Early (NYTimes)
  • FDA perspective on sofosbuvir therapy for patients with chronic hepatitis C virus genotype 1 infection who did not respond to treatment with pegylated interferon and ribavirin (PubMed)

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

  • Pfizer Announces FDA Acceptance For Review Of Supplemental New Drug Application For Oral XELJANZ (tofacitinib citrate) For Adult Patients With Moderate To Severe Chronic Plaque Psoriasis (Press)
  • Ignyta Receives Orphan Drug Designation from FDA for Entrectinib for the Treatment of Molecularly Defined Subsets of Non-Small Cell Lung Cancer (Press)

US: Pharmaceuticals and Biotechnology: General

  • How Can We Better Measure Biomedical Innovation? (Brookings)
  • To What Extent are Drug Makers Having Trouble Sustaining Innovation? (Pharmalot)
  • Pfizer To Acquire Hospira (Press)
  • Feds say marijuana has no medical value. Obama's new surgeon general seems to disagree. (Vox)
  • New York State Attorney General Reaches Deal to Reduce Price of Heroin Antidote (NYTimes)

US: Medical Devices

  • Public Citizen: Training Medical Devices Need to Have More Explicit Warnings on Labels (HuffPo)
  • Characteristics of Pivotal Trials and FDA Review of Innovative Devices (PubMed)
  • Sen. Warren goes to bat for medical device industry (TIME)
  • Medtronic's Pipeline Flex Embolization Device Receives FDA Approval (Press)
  • Becton Dickinson Loses Device Advertising Case Appeal (Press)
  • FDA Clears New Guidewire Controller for Cardiovascular Procedures (Press)
  • Koning wins FDA nod for 3D breast CT device (Mass Device)
  • MedShape Announces FDA Clearance Of New 3D Printed Titanium Bone Tether Plate That Preserves Bone Anatomy (Press)
  • IRIDEX Receives FDA Clearance For Cyclo G6™ Laser System For The Treatment Of Multiple Stages Of Glaucoma (Press)
  • Lombard Medical Receives FDA Approval for Aorfix Plus Endovascular Stent Graft Expanding Its Addressable Market (Press)

US: Dietary Supplements

  • Senators ask FDA for national investigation of dietary supplements (The Hill)
  • NY AG Brushes off Requests for Data on Supplement Investigation (NI-USA)
  • Failure to refer to established national standards calls AG investigation into question, experts say (NI-USA)

US: Assorted And Government

  • Margaret Hamburg to Resign Next Month (Reuters)
  • House passes regulatory reform bill (The Hill)
  • FDA Hiring New Safety, Security and Crisis Management Leader (USA Jobs)
  • Enforcement Report - Week of February 4, 2015 (FDA)
  • USPTO Launches Enhanced Patent Quality Initiative (PTO)

Upcoming Meetings

Ebola Outbreak

  • Ebola Drug Aids Some in a Study in West Africa (NYTimes) (Reuters)
  • The new Ebola target number: Zero cases (WaPo)

Europe

  • Review calls for global fund to fight dangerous superbugs (Pharmafile) (PharmaTimes) (Reuters)
  • Think you’re on track for 2018 EU serialisation? No you’re not (Outsourcing Pharma)
  • New antibiotics for skin infections get seal of approval from European Medicines Agency (PharmJournal-$)
  • THERAVECTYS Obtains Orphan Drug Designation from the European Medicines Agency for Its Lentiviral Vector-Based Therapeutic Vaccine against Adult T-Cell Leukemia and Lymphoma (Press)

India

  • India seeks to move barcode tracking on drugs further upstream (Fierce)
  • India jumps into the generic drug biz to compete with commercial players on price (Fierce)
  • India's IP stance in focus as TPP talks on drug trade policy drag on (Fierce)

China

  • New China FDA chief signals pricing reform a priority (BioCentury)
  • Waters, Chinese Pharmacopoeia Commission establish joint lab (BiospectrumAsia-$)

Canada

  • Investigation Accuses Health Canada of not Placing Adequate Warnings on Gardasil (The Star)

Australia

  • Australia Plans Sterner Warning Labels for NSAIDs (FDAnews-$)

Clinical Trials

  • Overcoming the Alzheimer's challenge, I-SPY style (SCRIP-$)

General Regulatory And Interesting Articles

  • Oral contraceptives linked with increased risk of brain tumours (PharmJournal-$)
  • Potential Parkinson's Drug Too Toxic to Use (NBC)
  • Rapid and Unexpected Weight Gain After Fecal Transplant (ICT)

Regulatory Reconnaissance #487 – 5 February 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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