Regulatory Focus™ > News Articles > Regulatory Recon: Update to FDA Overhaul Legislation Coming Soon (13 April 2015)

Regulatory Recon: Update to FDA Overhaul Legislation Coming Soon (13 April 2015)

Posted 13 April 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: Update to FDA Overhaul Legislation Coming Soon (13 April 2015)

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

In Focus: US

  • Update to FDA Overhaul Bill Due in Coming Weeks ( MorningConsult)
  • AstraZeneca's diabetes drug Onglyza may increase death rate, FDA says ( Reuters) ( Fierce) ( Bloomberg) ( Fierce) ( Pink Sheet-$) ( BioCentury) ( Tarius) ( SCRIP-$)
  • FDA Reverses Broad Abilify Approval, Otsuka Says ( Law 360-$)
  • Antibiotic use in livestock going up, up, up ( NRDC) ( FDA) ( Reuters) ( WSJ-$)
  • FDA Oncology Office Hopes Better Advice Will Lead To More Patient-Reported Outcomes Data ( Pink Sheet-$) ( Pink Sheet-$)
  • ‘Breakthrough’ Therapies: Information Requests A Sign Of Workload Problem? ( Pink Sheet-$)
  • FDA panel evaluating new aneurysm treatment devices ( ModernHealthcare)
  • First Firm Audited Under MDSAP Urges Companies To Pay Closer Attention To International Regs ( Gray Sheet-$)
  • FDA forces UCLA researchers to stop touting experimental dementia scan ( LA Times) ( NYTimes)

In Focus: International

  • Gilead under fire for Sovaldi anti-diversion policy ( PMLive)
  • India’s Medical device industry welcomes Task Force’s recommendations ( PharmaBiz)
  • IMDRF to pilot improved program on exchanging information on medical device incidents ( SCRIP RA-$)
  • Malaysian Fast-track Registration Pathway Unveiled ( Emergo)
  • Transatlantic Sunscreen Ingredient Alignment Could Flow From Trade Pact ( Tan Sheet-$)

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US: Pharmaceuticals and Biotechnology

  • AstraZeneca's diabetes drug Onglyza may increase death rate, FDA says ( Reuters) ( Fierce) ( Bloomberg) ( Fierce) ( Pink Sheet-$) ( BioCentury) ( Tarius) ( SCRIP-$)
  • FDA Reverses Broad Abilify Approval, Otsuka Says ( Law 360-$)
  • Antibiotic use in livestock going up, up, up ( NRDC) ( FDA) ( Reuters) ( WSJ-$)
  • FDA Oncology Office Hopes Better Advice Will Lead To More Patient-Reported Outcomes Data ( Pink Sheet-$) ( Pink Sheet-$)
  • ‘Breakthrough’ Therapies: Information Requests A Sign Of Workload Problem? ( Pink Sheet-$)
  • Pfizer Accused of Knowing Zoloft Posed Birth-Defect Risk ( Bloomberg)
  • Health Canada and FDA Joint Public Consultation on International Conference on Harmonisation Guidelines for Registration of Pharmaceuticals for Human Use ( Health Canada)
  • Politicians still going after Actavis for its Namenda hard-switch ( BioPharmaDive) ( Bloomberg)
  • Breast Cancer Patients, FDA Disagree On Value Of Time-To-Metastasis Endpoints ( Pink Sheet-$) ( Pink Sheet-$)
  • FDA Weighs in on Continuing Drug Shortages ( FDA)
  • FDA Issues Import Alert Agaisnt VUAB Pharma for CGMP Deficiencies ( FDA)
  • Ethics of drug trials in dire situations debated ( SCRIP-$)
  • Reagan-Udal Foundation Releases Request for Regulatory Proposals ( RUF)
  • FDA Shows Skin Authority Who’s Boss In Warning For Drug Claims ( Tan Sheet-$)
  • Baxter Initiates Voluntary Recall of Select Lots of IV Solutions Due to the Potential Presence of Particulate Matter ( FDA)

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

  • Once-daily Belviq NDA coming later this year ( SCRIP-$)
  • Reata Pharmaceuticals Receives Orphan Drug Designation For Bardoxolone Methyl ( Press)

US: Pharmaceuticals and Biotechnology: General

  • Glaxo Plans Changes to Compensation Program for U.S. Sales Team ( Bloomberg)
  • Vertex's Kalydeco combo could run payers $10M-plus per life, PBM figures ( Fierce)
  • Will The Pendulum Swing Back In IPR Proceedings? ( Law 360-$)
  • Oklahoma set to adopt nitrogen gas for executions ( AFP)

US: Medical Devices

  • FDA panel evaluating new aneurysm treatment devices ( ModernHealthcare)
  • First Firm Audited Under MDSAP Urges Companies To Pay Closer Attention To International Regs ( Gray Sheet-$)
  • FDA forces UCLA researchers to stop touting experimental dementia scan ( LA Times) ( NYTimes)
  • The Complex Effects Of The FDA’s Proposal To Regulate Laboratory-Developed Tests ( HealthAffairs)
  • An Interactive Discussion on the Clinical Considerations of Risk in the Post market Environment ( FDA)
  • CardiAQ Valve wins FDA nod for mitral valve trial ( MassDevice)
  • Report: Demise of NeuroControl a cautionary tale of 'Orphan Markets' for devicemakers ( Fierce)
  • NOVA View automated digital IFA microscope receives FDA de novo clearance ( Press)

US: Dietary Supplements

  • NYTimes Editorial Board Says a “Conflict of Interest” at FDA Over Supplement Safety ( NYTimes)
  • FDA Accused Of Dragging Heels On Dietary Supplement Dangers ( Forbes) ( NBC)
  • Schumer Backs Efforts to Ban Popular Stimulant ( WSJ-$)

US: Assorted And Government

  • Update to FDA Overhaul Bill Due in Coming Weeks ( MorningConsult)
  • Managing Engagement with the US FDA to Avoid Penalties ( FDA Attorney)
  • FDA’s Weekly Enforcement Report ( FDA)

Upcoming Meetings and Events

Ebola Outbreak

  • Tekmira gets the FDA's OK to resume its Ebola study ( Fierce) ( Reuters) ( Press)
  • Empty Ebola Clinics in Liberia Are Seen as Misstep in US Relief Effort ( NYTimes)
  • WHO: Ebola remains emergency; vaccine trials a 'challenge' ( SCRIP-$) ( WHO)

Europe

  • Transatlantic Sunscreen Ingredient Alignment Could Flow From Trade Pact ( Tan Sheet-$)
  • Draft qualification opinion of qualification of exacerbations of chronic pulmonary disease tool (EXACT), and EXACT-respiratory symptoms measure (E-RS) for evaluating treatment outcomes in clinical trials in COPD ( EMA)
  • Compilation of individual product-specific guidance on demonstration of bioequivalence ( EMA)
  • Conditional marketing authorization for Thiosix in Netherlands ( PharmaLetter-$)

India

  • Gilead under fire for Sovaldi anti-diversion policy ( PMLive)
  • India’s Medical device industry welcomes Task Force’s recommendations ( PharmaBiz)
  • Govt releases recommendations of Task Force on Promotion of Domestic Production of High End Medical Devices ( Business Standard)

China

Canada

  • Stringent Health Canada requirements restrict access to hormonal implants ( Globe and Mail)

Australia

  • Australia's lifesaving drug scheme review could require new evidence of real-life benefits  ( SCRIP-$)
  • Australia To Stop Payments To Families Who Refuse Child Vaccinations ( NPR)

Other International

  • IMDRF to pilot improved program on exchanging information on medical device incidents ( SCRIP RA-$)
  • Malaysian Fast-track Registration Pathway Unveiled ( Emergo)
  • Malaysian Regulators Lay Out Post-Market Surveillance Audit Framework ( Emergo)
  • Asian Industry Groups Progress Initiatives For Faster Approvals ( PharmAsia-$)

General Regulatory And Interesting Articles

  • Potency Assay Challenges and Pathways for Cell and Gene Therapies Explored by Industry/Regulator Expert Panel ( IPQ)
  • Polio Vaccine Found "Safe and Effective" 60 Years Ago: What Would Salk Think Today? ( NPR)
  • If compulsory licensing is the answer, what's the question? ( DrugWonks)
  • Introducing the “Virtual” Biotech Model. Two Employees, All Work Contracted Out ( Reuters)
  • Fecal transplant, stem cells may help Crohn's disease ( CBS)
  • Jonas Salk's Polio Vaccine Makes A Comeback ( NPR)

Regulatory Reconnaissance #534 – 13 April 2015

RegulatoryReconnaissance is our daily intelligence briefing for the regulatory affairsspace, bringing you the top regulatory news stories from around the globe. Eachweekday morning, we aim to bring you the latest highlights of new approvals,meetings, legal and political developments, regulations and guidance, and thelatest trends with the potential to impact regulatory affairs professionals andthe industry in which they work.

Need to contact theeditor of Regulatory Reconnaissance? Find him on Twitter at@AlecGaffney or send him anemail at news@raps.org.

A story's inclusion inRegulatory Reconnaissance does not imply endorsement by Regulatory Focus orRAPS.


Categories: Recon, Regulatory News

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