Regulatory Recon: Will FDA Have Enough Money to Hire the Staff it Needs? (22 June 2015)

Posted 22 June 2015 By Alexander Gaffney, RAC

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

In Focus: US

  • FDA May Lack Money to Carry Out Hiring Envisioned in 'Cures' Bill (Roll Call)
  • FDA Approves Eisai's Antiepileptic Agent Fycompa (Press) (Pharmafile) (PharmaTimes)
  • FDA Patent Rule Has Brands, Generics In War Of Words (Law 360-$) (FDA)
  • Google Search Engine Marketing Changing: How it Affects FDA (RegulatoryRx)
  • Pediatric Drug Safety Surveillance in FDA-AERS: A Description of Adverse Events from GRiP Project (PubMed)
  • Enforcing The "Least Burdensome" Requirement for Premarket Review of Devices (FDA Law Blog) (MassDevice)
  • Regulatory classification 101: A guide to how your medical device will be classified (MedCityNews)
  • Amendments to limit military access to supplements fail to make final bill (NI-USA)

In Focus: International

  • EU Device Reform Progresses With Council Amendments (Gray Sheet-$) (MDL) (Press) (Clinica-$) (Politico)
  • BMS' Opdivo first EU approved PD-1 inhibitor (PharmaTimes) (Press) (BioCentury)
  • NICE recommends infliximab biosimilars ahead of Remicade (PMLive)
  • CDSCO to upgrade manpower to enhance GMP compliance and quality of drugs (PharmaBiz)
  • In China, Illegal Drugs Are Sold Online in an Unbridled Market (NYTimes)
  • China Hunts GMP Gaps Before International Pharma Inspection Convention (Tan Sheet-$)

US: Pharmaceuticals and Biotechnology

  • FDA Approves Eisai's Antiepileptic Agent Fycompa (Press) (Pharmafile) (PharmaTimes)
  • FDA Patent Rule Has Brands, Generics In War Of Words (Law 360-$) (FDA)
  • Google Search Engine Marketing Changing: How it Affects FDA (RegulatoryRx)
  • Pediatric Drug Safety Surveillance in FDA-AERS: A Description of Adverse Events from GRiP Project (PubMed)
  • Biosimilar Sponsors Looking To Avoid 'Patent Dance' Turn To Inter Partes Review (Pink Sheet-$)
  • Bioequivalence To Duodopa Could Mean Quick Path To Market For NeuroDerm In Parkinson's (Pink Sheet-$)
  • Dr Reddy's Laboratories working on 18 new drug applications (India Times)
  • FDA Announces New Grant Funding Opportunity to Support Development of New Animal Drugs Intended for Minor Use or Minor Species (FDA)
  • Responder Definition of a Patient-Reported Outcome Instrument for Laryngopharyngeal Reflux Based on the US FDA Guidance (PubMed)

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

  • BI's Anticoagulant Reversal Drug Idarucizumab Succeeds in PhIII Study (Press)
  • FORUM Pharmaceuticals Inc. Receives FDA Fast Track Designation for Lead Compound Encenicline to Treat Cognitive Impairment in Schizophrenia (Press)
  • Vaxil's Lead Product ImMucin has Been Granted an Orphan Drug Designation by the FDA for the Treatment of Multiple Myeloma (Press)

US: Pharmaceuticals and Biotechnology: General

  • ​​Report: Big Pharma is getting more worried about drug price pushback (BizJournal)
  • Iowa Court Ruling Says Doctors Can Prescribe Abortion Drugs by Video (NYTimes)

US: Medical Devices

  • Enforcing The "Least Burdensome" Requirement for Premarket Review of Devices (FDA Law Blog) (MassDevice)
  • Regulatory classification 101: A guide to how your medical device will be classified (MedCityNews)
  • Lawsuit accuses J&J, hospital, doc of unauthorized ceramic-on-metal hip trials (MassDevice)
  • Class I Recall for Zimmer's M/L Taper With Kinectiv Technology Prosthesis Femoral Stems (FDA)

US: Dietary Supplements

  • Blumenthal/Durbin's amendments to limit military access to supplements fail to make final bill (NI-USA)
  • Sativex Cancer Drug Trial Poses Barrier to CBD in Supplements (NPI)
  • 8 accused of selling millions of counterfeit 5-Hour Energy drinks (LA Times)

US: Assorted And Government

  • FDA May Lack Money to Carry Out Hiring Envisioned in 'Cures' Bill (Roll Call)
  • House Budget Would Eliminate AHRQ (DD&D)
  • PwC's HRI regulatory center weekly newsletter  (PwC)
  • Enforcement Report - Week of June 17, 2015 (FDA)
  • SCRIP's US Capitol Capsule (SCRIP-$)

Upcoming Meetings and Events

Europe

India

  • CDSCO to upgrade manpower to enhance GMP compliance and quality of drugs (PharmaBiz)
  • Tough Gets Tougher For Global Firms And Indian Giants (Pink Sheet-$)

China

  • In China, Illegal Drugs Are Sold Online in an Unbridled Market (NYTimes)
  • China Hunts GMP Gaps Before International Pharma Inspection Convention (Tan Sheet-$)

Other International

  • Definition and Classification of Generic Drugs Across the World (PubMed)

General Regulatory And Interesting Articles

  • Tamper-Resistant Pill Dispenser Aims to Stamp Out Medication Misuse (MedGadget)
  • Gardasil-9 Effectively Stops 90 Percent Of Cancers Caused By HPV In Girls and Boys (Forbes)

Regulatory Reconnaissance #580 – 22 June 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 @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.

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