Regulatory Focus™ > News Articles > Regulatory Reconnaissance (22 October 2013)

Regulatory Reconnaissance (22 October 2013)

Posted 22 October 2013 | 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

  • Changing Biosimilar Naming Rules Is A 'Delay Tactic' (Pharmalot)
  • Alliance for a Stronger FDA's Steven Grossman: How Budget Battles Hurt FDA (BioCenturyTV)
  • FDA Cannot Regulate Stem Cell Treatments, DC Circ. Hears (Law 360-$)
  • Cybersecurity: Medtronic vows to protect devices from hackers (Mass Device) (MedCity News)
  • Lyme disease tests prompt regulators' concern (Boston Globe)
  • FDA responds to patient uprising over Bayer's Essure birth control implant (Mass Device)
  • Osiris Threatens to Sue Publication for Calling an Untitled Letter a Warning Letter (Press) (The Street) (FDA Untitled Letter) (Osiris)

In Focus: International

  • EU Commission Passes Amended Version of EU Parliament's Medical Device Directive Overhaul (EC)
  • Indian Supreme Court ruling on trial re-evaluations seen as 'retrospective review' (SCRIP-$) (MedCity News) (India Times)
  • Third Wockhardt India plant hit by export restrictions (India Times)
  • Unregistered vs fake - How terminology sparked a media war in Ghana (In Pharma)
  • Australia Launches Medical Device Single Audit Program Pilot (TGA)

US: Pharmaceuticals/Biotechnology

  • The Street's Feuerstein: FDA Slaps Osiris For Misleading Medical Claims About Stem-Cell Bandage (The Street) (FDA Untitled Letter) (Osiris)
  • Osiris to Feuerstein: We're Thinking About Suing You for Calling it a Warning Letter (Press)
  • Changing Biosimilar Naming Rules Is A 'Delay Tactic' (Pharmalot)
  • Alliance for a Stronger FDA's Steven Grossman: How Budget Battles Hurt FDA (BioCenturyTV)
  • FDA Cannot Regulate Stem Cell Treatments, DC Circ. Hears (Law 360-$)
  • Gilead and Johnson & Johnson Face the FDA this Week (Motley Fool)
  • Roche gains FDA approval for new subcutaneous formulation of Actemra for R.A. (Roche) (Genentech)
  • Lupin gets FDA nod for additional strengths of cholesterol drug Antara (India Times)
  • FDA approves Iroko's pain drug Zorvolex (SCRIP-$)
  • FDA Hiring Initiative: Generic Drug User Fee Amendments of 2012 (GDUFA) (FDA)
  • Another Compounding Pharmacy Sees Recall After Particulate Matter Found (FDA)
  • FDA, EMA Grant Orphan Designation to Pancreatic Cancer Drug (DD&D)
  • FDA Grants Orphan Drug Designation to Lipiodol (Ethiodized Oil) Injection for Management of Patients with Known Hepatocellular Carcinoma (HCC) (Press)
  • Regeneron reports positive Phase III data for Eylea (Pharma Letter-$) (SCRIP-$) (Fierce) (BioCentury)
  • Vertex's VX-509 meets in Phase IIb RA trial (BioCentury)
  • Roche's Avastin boosts survival in advanced ovarian cancer (Pharma Times)
  • Medivation and Astellas Announce The Phase 3 PREVAIL Trial of Enzalutamide Meets Both Co-Primary Endpoints (Press)
  • The FDA Should Provisionally Approve Vascepa (BioWorld)
  • Why Amarin Has To Finish Its Big Fish Oil Study (Forbes)

US: Pharmaceuticals and Biotechnology: General

  • A year later, fungal meningitis victims still suffering, but rebuilding (NBC)
  • As Cost of Some New Drugs Skyrockets, Doctors Begin to Take Notice (New York Mag)

US: Medical Devices

  • Cybersecurity: Medtronic vows to protect devices from hackers (Mass Device) (MedCity News)
  • Lyme disease tests prompt regulators' concern (Boston Globe)
  • FDA responds to patient uprising over Bayer's Essure birth control implant (Mass Device)
  • Cardiovascular Systems, Inc. Receives Coronary FDA Approval for Diamondback 360 Coronary Orbital Atherectomy System (Press)
  • Trial Date Set For BSX Vaginal Mesh Cases (WBJournal)
  • How ONC is getting back on track after gov't shutdown (GovHealthIT)
  • Health IT Regulators Face Challenges as Medical Apps Proliferate (National Journal)
  • Bayer lands FDA OK to pair with Medtronic's new 'artificial pancreas' (Mass Device)
  • Medtronic launches clot-removal tech in U.S. (MedGadget) (Fierce)
  • J&J Gets Approval for 3-D Vessel Reconstruction Tech (Press)
  • Class 1 Recall for H and H Medical Corporation's Emergency Cricothyrotomy Kit - Cuff Balloon May Not Function as Intended (FDA)
  • Varian Medical Systems Receives FDA 510(k) Clearance for RapidPlan Knowledge-Based Treatment Planning Software for Radiation Oncology (Press)
  • DoD ponies up $15M to develop Terumo's blood-cleaning tech (Fierce)

US: Dietary Supplements

  • FDA takes enforcement action against Oregon dietary supplement manufacturer (FDA)
  • Firms' Liability For User-Generated Content Remains Regulatory Gray Area (Tan Sheet-$)
  • USPlabs Denies Ingredient Aegeline is Unsafe (NPI)

US: Assorted And Government

  • Chamber's strategy on regs: 'When all else fails, sue 'em' (The Hill)
  • Meeting of the National Biodefense Science Board (DHHS)

Upcoming Meetings And Events

  • 17-18 October 2013: Anti-Infective Drugs Advisory Committee Meeting (FDA) (Day 2)
  • 21-22 October 2013: Public Workshop on Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT II) (FDA)
  • 22-23 October 2013: Cellular, Tissue and Gene Therapies Advisory Committee Meeting (FDA) (POSTPONED)
  • 23 October 2013: Investigational Device Exemption Process Meeting (FDA) (FDA)
  • 22-23 October 2013: FSMA Public Meeting Concerning Proposed Rules on Foreign Supplier Verification Programs and the Accreditation of Third-Party Auditors/Certification Bodies (FDA)
  • 24-25 October 2013: Antiviral Drugs Advisory Commitee Meeting (FDA) (Day 2)
  • 31 October 2013: Data Harmonization for Patient-Centered Clinical Research (IOM/PCORI)
  • 13 November 2013: Vaccines and Related Biological Products Advisory Committee Meeting (FDA)
  • 2-3 December 2013: AHWP/RAPS Joint Conference in Malasia (RAPS)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • EU Commission Passes Amended Version of EU Parliament's Medical Device Directive Overhaul (EC)
  • EU Parliament plenary vote on 22 October marks another milestone for medtech reg (Clinica-$)
  • Early Discount Makes Rejection of Astellas' Xtandi Too Difficult For NICE (Pink Sheet-$)

Asia

  • Indian Supreme Court ruling on trial re-evaluations seen as 'retrospective review' (SCRIP-$) (MedCity News) (India Times)
  • Third Wockhardt India plant hit by export restrictions (India Times)
  • Japan PMDA Announces Regulatory Strategy Consultation Results (PharmAsia-$)
  • India yet to seriously take up loopholes in new EU regulation on customs enforcement (PharmaBiz)

Other International

  • Unregistered vs fake - How terminology sparked a media war in Ghana (In Pharma)
  • Australia Launches Medical Device Single Audit Program Pilot (TGA)

Regulatory Reconnaissance #184 - 22 October 2013

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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