Regulatory Focus™ > News Articles > Regulatory Recon: FCC Releases Final MBAN Rule (6 October 2014)

Regulatory Recon: FCC Releases Final MBAN Rule (6 October 2014)

Posted 06 October 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: FCC Releases Final MBAN Rule (6 October 2014)

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

In Focus: US

  • FCC Releases Final Rule on Medical Body Area Networks (MBANs) ( FCC)
  • New FDA Guidance on use of PCR Endpoint to Support Accelerated Approval in Breast Cancer ( FDA) ( FDA)
  • Abuse-Deterrence Among New GDUFA Regulatory Science Priorities ( Pink Sheet-$)
  • Takeda loses in lawsuit claiming cancer link to Actos ( PMLive) ( Bloomberg) ( Press)
  • Chimerix Announces Emergency Investigational New Drug Applications for Brincidofovir Authorized by FDA for Patients With Ebola Virus Disease ( Press) ( Reuters)
  • The inadequacy of voluntary measures to reduce the use of antimicrobials in animal feed ( Harvard BOH)
  • ​'60 Minutes' Just Attacked High Drug Prices. Here's What You Should Know. ( Forbes) ( CBS)
  • New FDA Guidances for September 2014 ( Cato)

In Focus: International

  • Surprise! More about unannounced audits in the EU ( MDL)
  • Draft guideline on regulatory acceptance of 3R (Replacement, Reduction, Refinement) testing approaches ( EMA)
  • Adaptive clinical trial designs for European marketing authorization: a survey of scientific advice letters from the European Medicines Agency ( PubMed)
  • Report on Indian drug makers: India's legal threat a 'shocking overreaction', say US researchers ( India Times)
  • Taiwan FDA head, other officials disciplined over recycled oil scandal ( Want China Times)

US: Pharmaceuticals and Biotechnology

  • Guidance: Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer -- Use as an Endpoint to Support Accelerated Approval ( FDA) ( FDA)
  • Abuse-Deterrence Among New GDUFA Regulatory Science Priorities ( Pink Sheet-$)
  • AbbVie's Humira Gets FDA Approval For Extension Of Polyarticular JIA ( Nasdaq) ( Press)
  • FDA approves Gilead's Tybost, Vitekta ( BioCentury)
  • Takeda loses in lawsuit claiming cancer link to Actos ( PMLive) ( Bloomberg) ( Press)
  • The inadequacy of voluntary measures to reduce the use of antimicrobials in animal feed ( Harvard BOH)
  • What Will Biosimilar Labeling Look Like? Stakeholders Await FDA Guidance, Approvals ( Pink Sheet-$)
  • FDA’s Prefix Solution On Biologic Names Draws Fire ( Pink Sheet-$) ( IHP-$)
  • FDA Panel Showdown Coming Over Epidural Steroid Injection Safety ( Pink Sheet-$)
  • New CMC Submission Approach Needed to Foster Transparency and Continuous Improvement, PhRMA Team Says ( IPQ-$)
  • Judge Says ActavisNot Limited To Cash Deals ( Law 360-$)
  • Hydrocodone Rescheduling Comes into Effect ( Forbes)
  • Advancing the development of new “targeted drug therapies” by enhancing the science of biomarkers ( FDA)
  • Pulmonary Fibrosis Patients Talk Quality Of Life More Than Potential New Treatments ( Pink Sheet-$)
  • New Jersey Considering Restrictions on Substitution for Opioids ( Scout)
  • Sagent Pharmaceuticals Initiates a Nationwide Voluntary Recall of Three Lots of Ketorolac Tromethamine Injection, USP, 30mg/ml Due to Labeling the Product with the Incorrect Expiration Date ( FDA)

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

  • Alcobra's ADHD drug meets goals, after excluding some data ( Reuters) ( The Street)
  • Takeda Announces Phase 3 Data for UC, Crohn's Drug ( Press)
  • Orphan status for Horizon Pharma’s Actimmune in Friedreich's ataxia ( PharmaLetter-$) ( Press) ( PBR)
  • Sunesis Drug for Elderly Blood Cancer Patients Fails Phase III Study ( The Street) ( Press)
  • Amgen Announces Positive Data for Cholesterol-Lowering Medication ( Press)

US: Pharmaceuticals and Biotechnology: General

  • ​ '60 Minutes' Just Attacked High Drug Prices. Here's What You Should Know. ( Forbes) ( CBS)
  • New Viagra TV Ad Should Be Dropped ( Forbes)
  • Genentech Sales Reps Face Hospital Bans Over a Wholesale Change ( Pharmalot)
  • GPhA disputes lawmakers on generic prices ( BioCentury)
  • Pricing drugs: Shouldn’t it be based on outcomes? ( MedCityNews) ( PhillyPharma) ( Pink Sheet-$)
  • The Ethics of Kidney Transplants ( BioCentury)
  • US Capitol Capsule: Biopharma patent law back at Supreme Court with Copaxone ( SCRIP-$)

US: Medical Devices

  • FCC Releases Final Rule on Medical Body Area Networks (MBANs) ( FCC)
  • Stakeholders Ask FDA For Clarity, Rule Cementing Data Systems Downgrade ( Gray Sheet-$)
  • Feds Target NJ Co. Over Tainted Ultrasound Gels ( Law 360-$) ( FDA)
  • FDA Guidance On Medical Device Cybersecurity: Too Little Too Late? ( Forbes)

US: Dietary Supplements

  • FTC: All Advertisers Should Heed Lessons From “Operation Full Disclosure” ( Tan Sheet-$))

US: Assorted And Government

  • New FDA Guidances for September 2014 ( Cato)
  • Oxitec says genetically modified mosquitoes getting closer ( KeysInfoNet)
  • Doctors, Companies Say Physician Payment Database Contains Errors ( WSJ-$)
  • CBO Scores Sunscreen Innovation Act ( CBO)

Upcoming Meetings

Ebola Outbreak

  • Chimerix Announces Emergency Investigational New Drug Applications for Brincidofovir Authorized by FDA for Patients With Ebola Virus Disease ( Press) ( Reuters)
  • Trials of NewLink's Ebola vaccine 'imminent' ( PMLive) ( ScienceMag)
  • Ebola is in America – and, finally, within range of Big Pharma ( Guardian)
  • Ugandan Health Worker Dies Of Marburg Virus, Ebola Relative ( Forbes) ( Reuters)
  • No, Seriously, How Contagious Is Ebola? ( NPR)

Europe

  • Surprise! More about unannounced audits in the EU ( MDL)
  • Draft guideline on regulatory acceptance of 3R (Replacement, Reduction, Refinement) testing approaches ( EMA)
  • Adaptive clinical trial designs for European marketing authorization: a survey of scientific advice letters from the European Medicines Agency ( PubMed)
  • Transparency risks “misuse of data” says commissioner due to oversee regulation of medicines in EU ( AllTrials)
  • Managed Access Programmes: maintaining treatment access post-trial ( PharmaPhorum)
  • Clear conditions for biosimilars the best way to boost patient safety says Danish Pharmaceutical Association ( PharmaLetter-$)
  • NHS England consults on plans for Cancer Drugs Fund ( PharmaTimes)

India

  • Report on Indian drug makers: India's legal threat a 'shocking overreaction', say US researchers ( India Times)
  • DCGI concludes drive to check quality of medicines in Chhatisgarh ( PharmaBiz)
  • Govt to set up ADR monitoring centres in all medical colleges by 2015 ( PharmaBiz)

China

  • EFPIA Touts Innovative Medicines Model In China ( PharmAsia-$)

Other International

  • Taiwan FDA head, other officials disciplined over recycled oil scandal ( Want China Times)

Clinical Trials

  • Can Big Data Tell Us What Clinical Trials Don’t? ( NYTimes)

General Regulatory And Interesting Articles

  • Scientists ready to test lab-grown penises on men ( Guardian)
  • How zebrafish became the hottest animal in science ( Vox)
  • The online illicit drug economy is booming. Here’s what people are buying. ( WaPo)
  • Microneedle Patches Retrieve Multiple Biomarkers From Skin ( CEN)
  • Nobel Prize for medicine goes to discoverers of brain’s internal GPS ( Reuters)

Regulatory Reconnaissance #414 – 6 October 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

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe