Regulatory Focus™ > News Articles > Regulatory Recon: FDA: Approval Process Isn't Holding Targeted Medicine Back (17 July 2015)

Regulatory Recon: FDA: Approval Process Isn't Holding Targeted Medicine Back (17 July 2015)

Posted 17 July 2015 | By

Regulatory Recon: FDA: Approval Process Isn't Holding Targeted Medicine Back (17 July 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher and @RAPSorg on Twitter.

In Focus: US

  • More Collaboration, Research Needed to Develop Cures (FDA) (FDA Report) (SCRIP-$)
  • The FDA's Medical Device Problem (NYTimes)
  • Overview of Statements at PDUFA VI Meeting (DrugWonks)
  • Patient-Focused Drug Development for Huntington's and Parkinson's Diseases, Public Meeting (FDA)
  • Coalition Expects Higher Personalized Medicine Profile During User Fee Talks (GraySheet-$)
  • FDA warns about a serious lung condition in infants and newborns treated with Proglycem (FDA)    
  • Ensuring Access to Clinical Trials Act of 2015 passed by US Senate (PharmaLetter-$) (Press)
  • Novartis’ heart failure drug needs monitoring for safety, says AdverseEvents (PharmaLetter-$) (AdverseEvents)
  • FDA authorizes use of prosthesis for rehabilitation of above-the-knee amputations (FDA)
  • FDA Raises Design, Training Questions With Surgical Robots In Advance Of Workshop (GraySheet-$)
  • FCC clarifies regulations on medical devices that use radiofrequency (FierceMedicalDevices)

In Focus: International

  • EMA Data-Sharing Plan Seeks To Speed Up Relative Effectiveness Assessments (Pink Sheet-$)
  • Certificate withdrawals: are UK and Irish notified bodies the strictest in Europe? (Clinica-$)
  • Position Paper on how to Best Formulate Research Recommendations for Additional Evidence Gathering (EUnetHTA)
  • EMVO Efforts against Falsified Medicines Invigorated by Appointment of New President (EFPIA)
  • Unauthorized Eye Drops Seized from two Richmond, BC Retailers (Health Canada)
  • Wockhardt recalls over 162,000 cartons of drugs in US (Economic Times)
  • Apotex recalls about 92,000 bottles of hypertension drug in US (Economic Times)

US: Pharmaceuticals and Biotechnology

  • More Collaboration, Research Needed to Develop Cures (FDA) (SCRIP-$)
  • Overview of Statements at PDUFA VI Meeting (DrugWonks)
  • Coalition Expects Higher Personalized Medicine Profile During User Fee Talks (GraySheet-$)
  • FDA warns about a serious lung condition in infants and newborns treated with Proglycem (FDA)
  • Gilead Limits Enrollment in its Hep C Patient Program to Pressure Insurers (Pharmalot)
  • Bio-Better Outcome on Biosimilars For FDA In Senate Funding Report (Pink Sheet-$)
  • Why some new drugs are truly earning the 'innovative' label (BioPharmaDive)
  • Novartis’ heart failure drug needs monitoring for safety, says AdverseEvents (PharmaLetter-$) (AdverseEvents)

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

  • FDA approves supplemental BLA for Ipsen's Dysport (PharmaLetter-$) (Press)
  • Galderma Receives FDA Approval for New Antibiotic-Free Treatment Option for Acne Patients (Press)
  • Amgen reports positive preliminary results on leukemia drug (Reuters)
  • Baxalta Hemophilia A Drug Shows Strong Results in PhaseII/III Trial (FierceBiotech) (Press)

US: Pharmaceuticals and Biotechnology: General

  • Public Meeting on Patient-Focused Drug Development for Huntington's and Parkinson's Diseases (FDA)
  • Notice of Meeting : Vaccines and Related Biological Products Advisory Committee (Federal Register)
  • The Future of Clinical Trial Design Is Here in the Lung-MAP Clinical Trials (Geeks Talk Clinical)
  • New Chart Pack: Biopharmaceuticals in Government Programs (The Catalyst)

US: Medical Devices

  • The FDA's Medical Device Problem (NYTimes)
  • FDA authorizes use of prosthesis for rehabilitation of above-the-knee amputations (FDA)
  • FDA Raises Design, Training Questions With Surgical Robots In Advance Of Workshop (GraySheet-$)
  • FCC clarifies regulations on medical devices that use radiofrequency (FierceMedicalDevices)
  • FDA: Medtronic’s Shiley trach tube recall is Class I (MassDevice)
  • Improved graft shows hope in treating pediatric heart surgery (MassDevice)
  • Combination Product cGMPs: Your Compliance Strategy (MDDI)
  • Intermountain to Test Smartphone ECG Against 12 Traditional ECGs for Heart Attack Detection (MobiHealthNews)
  • Novo Nordisk says Flexpro PenMate gets FDA approval (Reuters) (MassDevice) (Press)
  • Bard, Gore Score Wins in 2nd Stent Graft Case (MassDevice)
  • Novartis, PPD conduct clinical pilot study using medical device connectivity via a smartphone app (FierceMedicalDevices)

US: Assorted and Government

  • Oregon follows California and allows pharmacists to prescribe birth control (MedCityNews) (MedPageToday)
  • Vote Delayed on House Patent Bill (BioCentury) (Law360-$)
  • Guidance for Industry on Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application (FDA)
  • Supplements: Erroneous FDA Guidance Continues to Plague Industry (FDA Law Blog)
  • Ensuring Access to Clinical Trials Act of 2015 passed by US Senate (PharmaLetter-$) (Press)
  • FDA shuts down Miami-area blood bank for multiple violations (Miami Herald) (FDA)

Upcoming Meetings and Events

Europe

  • EMA Data-Sharing Plan Seeks To Speed Up Relative Effectiveness Assessments (Pink Sheet-$)
  • Certificate withdrawals: are UK and Irish notified bodies the strictest in Europe? (Clinica-$)
  • Position Paper on how to Best Formulate Research Recommendations for Additional Evidence Gathering (EUnetHTA)
  • EMVO Efforts against Falsified Medicines Invigorated by Appointment of New President (EFPIA)
  • Three New Draft Documents on Immunological and Antibiotic Veterinary Medicines (EMA 1, 2, 3)
  • EC OKs Bristol-Myers' Evotaz to Treat HIV-1 Infection in Adults (Press)

India

  • India's Tergene Biotech develops vaccine for pneumonia (BioSpectrum)
  • Wockhardt recalls over 162,000 cartons of drugs in US (Economic Times)
  • Apotex recalls about 92,000 bottles of hypertension drug in US (Economic Times)
  • Medicines for diabetes, infections to cost 40 per cent less (Economic Times)

Australia

  • TGA approved terminology for medicines (TGA)

Canada

  • Unauthorized Eye Drops Seized from two Richmond, BC Retailers (Health Canada)

Ebola Outbreak

  • GSK and J&J/Bavarian Nordic take Ebola candidates to Senegal, Europe (FierceVaccines)

Other International

General Regulatory and Interesting Articles

  • A popular blood thinner and its devastating effects (NECIR)
  • CF Case Study: How Patients can get Costly Orphans Reimbursed (SCRIP-$)
  • FDA Appropriation Bill Holds Key To Electronic Cigarette Marketing (Tan Sheet-$)

Regulatory Reconnaissance #598– 17 July 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 @Michael_Mezher 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.


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