Regulatory Focus™ > News Articles > Regulatory Recon: Former FDA Commissioner Says Agency too Risk Averse (25 August 2014)

Regulatory Recon: Former FDA Commissioner Says Agency too Risk Averse (25 August 2014)

Posted 25 August 2014 | By Alexander Gaffney, RAC

Regulatory Recon: Former FDA Commissioner Says Agency too Risk Averse (25 August 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 by 29 August 2014 to receive the lowest rate.

In Focus: US

  • GlaxoSmithKline's ViiV wins FDA nod for three-in-one HIV treatment ( Fierce) ( SCRIP-$) ( Press) ( Pharma Times)
  • U.S. approval of Merck cancer immunotherapy expected soon ( Reuters)
  • 150 Years of FDA ( BioCenturyTV)
  • Former FDA head says biotech business model 'is basically falling apart' ( BioFlash)
  • ANDA Lull Begins: OGD Receives Four Applications In July ( Pink Sheet-$)
  • FDA Review Division Takes Steps To Get Clear Answer From Advisory Panel ( Pink Sheet-$)
  • J&J Paid Over $150K to Doctor Who Sat on FDA Safety Panels ( New Brunswick Today)
  • FDA AdComm to Meet on Boston Scientific's Watchman LAA Device ( FDA)

In Focus: International

  • ICH plans new guidance on multi-regional clinical trials ( Outsourcing Pharma)
  • ICH Steering Committee endorses the establishment of new Efficacy EWGs ( ICH)
  • Drug cost watchdog chief calls for honesty with public ( FT-$)
  • EFPIA, EGA take issue with EMA’s guidance on stability data for APIs ( In-Pharma)
  • Indian Drugmakers to Boost Spending on Regulatory Compliance ( The Telegraph)
  • New Headache Emerges For Foreign Medtech Firms in China ( MDDI)

US: Pharmaceuticals and Biotechnology

  • GlaxoSmithKline's ViiV wins FDA nod for three-in-one HIV treatment ( Fierce) ( SCRIP-$) ( Press) ( Pharma Times)
  • U.S. approval of Merck cancer immunotherapy expected soon ( Reuters)
  • 150 Years of FDA ( BioCenturyTV)
  • Former FDA head says biotech business model 'is basically falling apart' ( BioFlash)
  • 8-K from Alexion Pharma Shows FDA Issued Form 483 at Aug. Inspection of Site ( Benzinga)
  • ANDA Lull Begins: OGD Receives Four Applications In July ( Pink Sheet-$)
  • New Generics Team Will Improve Review Efficiency, Consistency ( Pink Sheet-$)
  • FDA Review Division Takes Steps To Get Clear Answer From Advisory Panel ( Pink Sheet-$)
  • Why drugs fail to get approved ( Eye for Pharma)
  • Spiriva Respimat Highlights Me-Too Risk Calculations: How Clean Does Safety Need To Be? ( Pink Sheet-$)
  • Iroko Pharmaceuticals Gains FDA Approval of ZORVOLEX for Management of Osteoarthritis Pain ( Press)
  • Chicago v. Opioid Mfrs.: Purdue Wants Former AG Dropped As City’s Counsel ( Pink Sheet-$) ( NYTimes)
  • Drug Trials: The Challenge of Outside Data ( Pharmalot)
  • FedEx Board Sued Over DOJ Drug Investigation ( Law 360-$)
  • US Capitol Capsule: Overhauling the biomedical enterprise: A fatigued conversation? ( SCRIP-$)
  • Hydrocodone limits may affect long-term-care patients: critics ( Modern Healthcare)
  • New Rules For Hydrocodone: What You Should Know ( Forbes) ( FDA Law Blog)
  • North Dakota parents seek drug for dying sons ( News Observer)
  • House Members, Trade Group At Odds Over CPSC Report On Phthalate Risks ( Tan Sheet-$)

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

  • Allergic reactions force Regado to pull the plug on PhIII anticoagulant study ( Fierce) ( Reuters)
  • Alkermes Submits New Drug Application to FDA for Aripiprazole Lauroxil for Treatment of Schizophrenia ( Press)
  • Insys Therapeutics Receives FDA Orphan Drug Designation for Its Pharmaceutical Cannabidiol as a Potential Treatment for Glioblastoma Multiforme ( MarketWatch)
  • Hera Therapeutics’ HTI-1968 shuts down HPV that causes most cervical cancer ( Pharma Letter-$) ( Press)
  • Genentech stops Erivedge IPF study before it starts ( SCRIP-$)
  • Study highlights cardiac risk of commonly prescribed antibiotic ( PJO)

US: Pharmaceuticals and Biotechnology: General

  • Final Rule on Branded Rx Drug Fee Treats All NDAs the Same, but IRS Might Consider a Special Rule for Pre-Hatch-Waxman Paper NDAs ( FDA Law Blog)
  • Pharma Supply Chain Companies Organize To Establish Global Traceability Data Exchange Architecture ( RxTrace)

US: Medical Devices

  • J&J Paid Over $150K to Doctor Who Sat on FDA Safety Panels ( New Brunswick Today)
  • FDA AdComm to Meet on Boston Scientific's Watchman LAA Device ( FDA)
  • Arthrosurface Receives FDA Clearance for the KISSloc Hallux Valgus Correction System ( Press)
  • Nipro Diagnostics, Inc. Announces FDA Clearance of its Newest Blood Glucose Monitoring Systems, TRUE METRIX and TRUE METRIX PRO, and Expansion of Manufacturing in the USA ( Press)

US: Assorted And Government

  • Regulations.gov is a Disaster Waiting to Occur ( OIRA Watch)

Ebola Outbreak

  • FDA seeks to dispel Ebola outbreak fears ( The Hill) ( FDA)
  • Liberian doctor who received rare Ebola drug ZMapp dies ( Reuters)
  • Speeding up the fight against Ebola, other diseases ( Boston Globe)
  • Japan could offer unapproved Ebola drug ( Reuters) ( PharmAsia-$)
  • Poll finds many in US lack knowledge about Ebola and its transmission ( Press)
  • Americans, Stop Worrying About Ebola: Every U.S. Case Thusfar Has Been A False Alarm. ( Forbes)

Europe

  • Drug cost watchdog chief calls for honesty with public ( FT-$)
  • EFPIA, EGA take issue with EMA’s guidance on stability data for APIs ( In-Pharma)
  • List of texts adopted at the June 2014 session of the PhEur Commission ( EurPh)

India

  • Indian Drugmakers to Boost Spending on Regulatory Compliance ( The Telegraph)
  • GPMA, IPA join hands to sensitise industry on MHRA's data integrity requirements ( PharmaBiz)

China

  • New Headache Emerges For Foreign Medtech Firms in China ( MDDI)

Japan

  • NIFDC Finds Sterility Problems At Yisheng Subsidiary ( PharmAsia-$)

Other International

  • ICH Steering Committee endorses the establishment of new Efficacy EWGs ( ICH)
  • Argentina opens $6 billion industry for Indian pharmaceutical companies ( India Times)

Clinical Trials

General Regulatory And Interesting Articles

  • How tech could spell the end of animals in drugs testing ( Guardian) ( Pharma Letter-$)
  • Armed with 3-D Printers, Amateurs Challenge the Medtech Paradigm ( MDDI)
  • Stanford bioengineers close to brewing opioid painkillers without using opium from poppies ( Press)

Regulatory Reconnaissance #385 – 25 August 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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