Regulatory Focus™ > News Articles > Regulatory Recon: Industry Calls FDA's Twitter Guidance Unconstitutional (23 September 2014)

Regulatory Recon: Industry Calls FDA's Twitter Guidance Unconstitutional (23 September 2014)

Posted 23 September 2014 | By Alexander Gaffney, RAC

Regulatory Recon: Industry Calls FDA's Twitter Guidance Unconstitutional (23 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, or check out some of the most news-worthy sessions here.

In Focus: US

  • FDA Twitter Rules Unconstitutional, Big Pharma Says ( Law 360-$) ( FDA)
  • FDA Readies Quality Metrics Measures ( PharmExec)
  • Contrave highlights data protection conundrum facing CV outcomes studies ( BioCentury-$)
  • Biologic Product Exclusivity Decisions Will Involve Sponsor Dialogue, FDA Says ( Pink Sheet-$)
  • FDA meeting on abuse-deterrent opioids ( BioCentury) ( FDA)
  • Generic Drug Makers Seek Accurate, Complete Inactive Ingredients Database ( IHP-$)
  • FDA allows marketing of the first test to identify five yeast pathogens directly from a blood sample ( FDA)
  • Collaborative Approaches for Medical Device and Healthcare Cybersecurity ( FDA)
  • Watchman data get worse as third panel approaches ( EP Vantage) ( Mass Device)
  • U.S. agency moves to end sex bias in biomedical research ( Reuters)
  • Judge Crushes Claim That FDA Warning Is Akin To A Taking ( Law 360-$)

In Focus: International

  • Ebola drug trials to be fast-tracked in West Africa ( Reuters)
  • NICE: Draft Guidance in Context ( Context Matters)
  • Janssen ‘extremely disappointed’ by NICE’s Olysio guidance ( PMLive)
  • GSK accidentally dumps 'liquid contaminated with poliovirus' into Belgian sewer system ( Fierce)
  • Indian Government withdraws NPPA's power to cap non-essential drug prices ( India Times) ( India Times) ( PharmaBiz) ( Reuters)

US: Pharmaceuticals and Biotechnology

  • FDA Twitter Rules Unconstitutional, Big Pharma Says ( Law 360-$) ( FDA)
  • FDA Readies Quality Metrics Measures ( PharmExec)
  • Contrave highlights data protection conundrum facing CV outcomes studies ( BioCentury-$)
  • Biologic Product Exclusivity Decisions Will Involve Sponsor Dialogue, FDA Says ( Pink Sheet-$)
  • FDA meeting on abuse-deterrent opioids ( BioCentury) ( FDA)
  • Generic Drug Makers Seek Accurate, Complete Inactive Ingredients Database ( IHP-$)
  • FDA “JumpStart” Data Service Gives Reviewers Leg Up On Complex NDAs ( RPM Report-$)
  • OTC Umbrella Branding Soaked By Regulatory Storm In Draft Guidance – CHPA ( Tan Sheet-$)
  • Congress Must Ensure FDA Does Not Undermine Biosimilars ( Roll Call)
  • Kentucky Seeks Restrictions on Dextromethorphan ( USA Today)
  • Senators Urge White House to Request Resources for FDA's NARMS Program ( Senate)
  • Draft Guidance on Estradiol ( FDA)

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

  • MedImmune Receives Fast Track Designation from FDA for Development of MEDI3902 for Prevention of Nosocomial Pneumonia ( Press)
  • FDA lifts clinical hold on Halozyme's PEGPH20 pancreatic cancer trial ( Pharma Letter-$)
  • NOXXON Spiegelmer Receives FDA Orphan Drug Designation ( Press)
  • Threshold down on Phase III data delay ( BioCentury)
  • Elusys Announces Results From Three Phase 3 Safety Studies Of Its Anthrax Anti-Toxin, Obiltoxaximab (ETI-204), In Adult Volunteers And Completion Of Its Phase 3 Clinical Development Program ( Press)

US: Pharmaceuticals and Biotechnology: General

  • Try Harder: The OIG Warns Drug Companies of Potential Liability for Medicare Beneficiaries’ Use of Copay Coupons ( FDA Law Blog) ( Pharmalot)
  • Analysis: Spotty coverage for rare disease drugs on exchanges ( The Hill)

US: Medical Devices

  • FDA allows marketing of the first test to identify five yeast pathogens directly from a blood sample ( FDA)
  • Collaborative Approaches for Medical Device and Healthcare Cybersecurity ( FDA)
  • Watchman data get worse as third panel approaches ( EP Vantage) ( Mass Device)
  • The Case For Disappearing Stents: More Positive Data For Abbott’s Absorb BVS ( Gray Sheet-$)
  • St. Jude chases MRI-friendly labeling for its CRM devices ( Mass Device)
  • FDA silent on power morcellation ( Democrat and Chronicle)
  • GE Healthcare Announces FDA Clearance of Discovery IQ ( Press)
  • Sequenom keeps prenatal Dx competition running with new positive data ( Fierce)
  • Advisory Committee on the Medical Uses of Isotopes: Call for Nominations ( NRC)
  • University of Louisville working on 'bioficial heart' using 3-D printing ( Fierce)

US: Dietary Supplements

  • Male Sex Enhancement Pill Maker Can't Escape False Ad Suit ( Law 360-$)

US: Assorted And Government

  • U.S. agency moves to end sex bias in biomedical research ( Reuters)
  • Judge Crushes Claim That FDA Warning Is Akin To A Taking ( Law 360-$)
  • Drug, device CEOs voice concerns about Sunshine Act ( The Hill) ( Gray Sheet-$) ( Press)
  • FDA Awards Harvard Pilgrim $14M for Sentinel Project ( FDA)
  • Impact of sending email reminders of the legal requirement for posting results on ClinicalTrials.gov: cohort embedded pragmatic randomized controlled trial ( PubMed)

Upcoming Meetings

Ebola Outbreak

  • Ebola drug trials to be fast-tracked in West Africa ( Reuters)
  • Doctor Recovering From Ebola Got Experimental Tekmira Drug ( NBC)
  • Ebola could strike 20,000 in six weeks, 'rumble on for years': study ( Reuters) ( NYTimes) ( SCRIP-$)
  • Ebola Death Rate 70 Percent, WHO Says in Dire New Forecast ( NBC)

Europe

  • NICE: Draft Guidance in Context ( Context Matters)
  • EU gives nod to Merck's poultry vaccine to fight infectious bronchitis ( Fierce)
  • Janssen ‘extremely disappointed’ by NICE’s Olysio guidance ( PMLive)
  • GSK accidentally dumps 'liquid contaminated with poliovirus' into Belgian sewer system ( Fierce)
  • Medtronic wins CE Mark for Tyrx cardiac device envelope ( Mass Device) ( Press)
  • Somahlution Announces CE Mark and European Launch of DuraGraft Vascular Conduit Solution ( Press)
  • Almost half of cancers in England diagnosed late ( OnMedica)

India

  • Government to take measures to plug the gaps on quality of drugs, to includes new checks ( India Times)
  • Government withdraws NPPA's power to cap non-essential drug prices ( India Times) ( India Times) ( PharmaBiz) ( Reuters)
  • Indian PM’s U.S. Visit Being Watched For IP Reassurance ( PharmAsia-$)

Other International

  • Malaysia concerned over fake drug registrations ( BioSpectrum)

Clinical Trials

  • Impact of sending email reminders of the legal requirement for posting results on ClinicalTrials.gov: cohort embedded pragmatic randomized controlled trial ( PubMed)
  • U.S. agency moves to end sex bias in biomedical research ( Reuters)
  • Ebola drug trials to be fast-tracked in West Africa ( Reuters)

Regulatory Reconnaissance #405 – 23 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 theeditor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.

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


Categories: Recon, Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe