Regulatory Focus™ > News Articles > Regulatory Recon: Pew Pushes Device Registries to Enhance Postmarket Safety (3 September 2014)

Regulatory Recon: Pew Pushes Device Registries to Enhance Postmarket Safety (3 September 2014)

Posted 03 September 2014 | By Alexander Gaffney, RAC

Regulatory Recon: Pew Pushes Device Registries to Enhance Postmarket Safety (3 September 2014)

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

This fall, regulatory professionals from across the globe will come together to learn, connect and share at the Regulatory Affairs Professionals Society’s 2014 RAPS: The Regulatory Convergence, 27 September-1 October, Austin, TX.  Register here.

In Focus: US

  • How Medical Device Registries can Advance Public Health and Enhance Approvals (Pew) (Pew) (Modern Healthcare) (MDDI) (Gray Sheet-$)
  • L’Oreal Sunscreen TEA Is Latest To Fall Short On Safety, Efficacy, Adverse Event Data (Tan Sheet-$)
  • FDA Posts Briefing Materials for Upcoming Sunscreen NDAC Meeting (SAC)
  • How Fast Should a Generic Drug Maker Update Labeling With new Safety Info? (Pharmalot)
  • Final trial confirms efficacy of Sanofi's dengue vaccine (Reuters) (Bloomberg)
  • GE Healthcare wins pivotal FDA approval for 3D breast imaging (Mass Device) (Dow Jones) (WSJ-$) (Reuters) (Press)
  • Hi-Tech Execs Ordered To Jail For Contempt Of Recall Order (Law 360-$)

In Focus: International

  • EU OK for Allergan's Ozurdex in diabetic eye condition (Pharma Times) (PMLive)
  • Medtronic Announces CE Mark for Recapturable CoreValve Evolut R System (Press)
  • Indian Health ministry to set up expert panel to re-examine issue of allowing trial in hospitals with less than 50 beds (PharmaBiz)
  • Indian pharmaceutical excipients cos get together to form IPEC India (PharmaBiz)
  • China Authorities Nab Gang That Produced 90 Million Toxic Capsules (PharmAsia-$)

US: Pharmaceuticals and Biotechnology

  • L’Oreal Sunscreen TEA Is Latest To Fall Short On Safety, Efficacy, Adverse Event Data (Tan Sheet-$)
  • FDA Posts Briefing Materials for Upcoming Sunscreen NDAC Meeting (SAC)
  • FDA Looking for New Head of CDER Communications (Eye on FDA) (DrugWonks)
  • How Fast Should a Generic Drug Maker Update Labeling With new Safety Info? (Pharmalot)
  • Pew Weighs in on FDA's 503B Compounding Guidance (Pew)
  • Calif. antibiotics bill awaits Brown’s approval (Capital Press)
  • Drug risk assessment and data reuse (PubMed)
  • Break on through to the other side: how FDA can rescind breakthrough designation (AGG-PDF)
  • The Generic Drug Labeling Carve-Out Scorecard (FDA Law Blog)
  • Republican Rep. Wants OTC Birth Control (The Hill)
  • Former Cetero researcher rebukes US FDA over warning letter (Outsourcing Pharma)
  • FDA Issues Draft Guidance Recommending Global Standard Format for Veterinary Medical Products Electronic Records (FDA) (FR)
  • Actavis Faces Shortage of Slow-Release Alzheimer’s Drug (Bloomberg)
  • Explanation of FDA's Approval of Bedaquiline (FDA)
  • Drug Cos. Call Chicago's Painkiller Marketing Suit Unwieldy (Law 360-$)
  • Arizona Petitions Supreme Court for Right to Restrict Abortion Drug RU-486 (AZ Daily)
  • Martin Avenue Pharmacy, Inc. Issues a Voluntary Multi-State Recall of All Compounded Sterile Preparations Due to a Lack of Assurance of Sterility (FDA)
  • Dermatend Original and Dermatend Ultra: Recall - Safety Concerns (FDA)
  • My Dog Has Cancer: What Do I Need to Know? (FDA)
  • Zohydro maker responds to governors (Bennington Banner)

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

  • Final trial confirms efficacy of Sanofi's dengue vaccine (Reuters) (Bloomberg)
  • Actinium Files Orphan Drug Application for Use of Actimab-A in the Treatment of Newly Diagnosed Acute Myeloid Leukemia in Elderly Patients (Press)
  • Birken to file wound healing drug on positive PhIII data (SCRIP-$)
  • Teva finds positive results in advanced trials for asthma drug (Reuters)
  • BMS' Eliquis Effective in Reducing All-Cause Hospitalization in Phase 3 Trial (MPR)
  • Stable CAD study shows no benefit with ivabradine (BioCentury) (Fierce)

US: Pharmaceuticals and Biotechnology: General

  • 22nd BioCentury Back to School Issue: Time to try new pricing schemes (BioCentury)
  • BARDA adds $17m to Chimerix smallpox contract (SCRIP-$)
  • New Genzyme pill will cost patients $310,250 a year (Boston Globe)
  • Targeted therapies left out of ASCO breast cancer guideline for now (SCRIP-$)

US: Medical Devices

  • GE Healthcare wins pivotal FDA approval for 3D breast imaging (Mass Device) (Dow Jones) (WSJ-$) (Reuters) (Press)
  • How Medical Device Registries can Advance Public Health and Enhance Approvals (Pew) (Pew) (Modern Healthcare) (MDDI) (Gray Sheet-$)
  • AdvaMed Opposes FDA Reclassification Proposal (MDDI)
  • SenoClaire Breast Tomosynthesis System Now FDA Approved (MedGadget)
  • Infographic: FDA's multi-layer regulatory structure for mobile medical apps (Fierce)
  • IRADIMED Receives FDA Warning Letter (Press)
  • Apple's HealthKit and the FDA: A match made in heaven? (mHealthNews)
  • Ortho Development Receives FDA Clearance for Alpine Hip Stem (Press)
  • Arthrosurface receives FDA 510(k) clearance for KISSloc Suture System (Beckers Spine)
  • Vital Connect HealthPatch MD Continuous Vitals Monitor Cleared for Home Use (MedGadget) (Fierce)
  • K2M Receives 510(k) Clearance & CE Mark for MESA Hooks Used in Complex Spine Procedures (Press)
  • EDGE gets FDA clearance for VIEW Plating System and REDUCE Fracture Plating System (Press)
  • June 2014 PMA Approvals (FDA)
  • ZIMMER develops a “once-in-a-lifetime” hip replacement that lasts 34 years (OrthoSpine News)

US: Dietary Supplements

  • Hi-Tech Execs Ordered To Jail For Contempt Of Recall Order (Law 360-$)
  • Vitamin Shoppe Sued Over Supplement False Labeling (Law 360-$)

US: Assorted And Government

  • FDA's Regulatory Office Looking to Hire New Director of Partnerships (FDA)
  • New FDA Guidances for August 2014 (Ask Cato)

Upcoming Meetings

Ebola Outbreak

Europe

  • EU OK for Allergan's Ozurdex in diabetic eye condition (Pharma Times) (PMLive)
  • NICE: Cancer Drugs Fund must use our processes (Pharmafile) (Pharma Times)
  • Amgen submits evolocumab MAA (BioCentury) (SCRIP-$)
  • Amgen submits talimogene MAA (BioCentury) (Press) (Fierce) (SCRIP-$)
  • Medtronic Announces CE Mark for Recapturable CoreValve Evolut R System (Press)
  • Ranier’s unique material Anatom-C Fusion cage receives CE mark (OrthoSpineNews)
  • Gangsters imported fake drugs from Asia says Europol (In-Pharma) (Fierce)
  • Is your auditor who they say they are? Preparing for unannounced audits - and unwanted visitors (Clinica-$)
  • Be ready for EU packaging safety regulations (PharmaPhorum)
  • NICE calls on pharmacists to check patients’ drug allergy status (PJO) (Pharma Times)
  • Cerenis Receives EMA Orphan Drug Designations for CER-001 for the Treatment of ApoA-I and ABCA-1 Deficiencies (Press)

India

  • Health ministry to set up expert panel to re-examine issue of allowing trial in hospitals with less than 50 beds (PharmaBiz)
  • Indian pharmaceutical excipients cos get together to form IPEC India (PharmaBiz)
  • DICs need to be effective to generate awareness about ADRs among patients to avoid tragedies: Experts (PharmaBiz)
  • India, Japan Meeting Fails To Remove Pharma Barriers (PharmAsia-$)

China

  • China Authorities Nab Gang That Produced 90 Million Toxic Capsules (PharmAsia-$)
  • CFDA Clears NovaBay’s NeutroPhase Skin and Wound Cleanser for Sale (Press)

Australia

  • Questions and answers about the registration process for prescription medicines in Australia (TGA)

Other International

  • Intl civil society groups call upon ICDRA participants to ensure access to affordable biotherapeutic products (PharmaBiz)

Clinical Trials

  • TransCelerate recommends what to protect in trial transparency efforts (In-Pharma)
  • Fantasy Video Game Teaches Kids About Clinical Trials (Press)

General Regulatory And Interesting Articles

  • Ensuring the Quality of Synthetic Peptides (USP)
  • Harvard researchers invent a 50-cent test for sickle cell disease in the developing world (MedCity News)

Regulatory Reconnaissance #391 – 3 September 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.

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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