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Regulatory Reconnaissance (8 November 2013)

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By Alexander Gaffney, RF News Editor

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org.

In Focus: US

  • First five agents selected for lung cancer initiative (BioCentury) (Forbes)
  • Regulations.Gov Knocked Out for More than 24 Hours, Many Documents Missing (The Hill)
  • Senate Prepares to Take up Drug Quality and Security Act (Bill)
  • Iclusig Deaths Won't Stall FDA's Speedier Drug Approvals (Law 360-$)
  • Sanofi Sues FDA to Prevent Disclosure of OTC NASACORT Labeling Before Product Launch (FDA Law Blog)
  • FDA, Canadian Regulators Join Forces To Curb Illegal Pharmacies (IHP-$)
  • Medtronic wins FDA nod to use software with competitors' tech (Fierce) (Mass Device)

In Focus: International

  • EU agency questions AstraZeneca over heart drug trial (Reuters) (Pharmafile)
  • PRAC recommends using acipimox only as additional or alternative treatment to lower high triglyceride levels (EMA)
  • PRAC recommends suspension of diacerein-containing medicines (EMA)
  • India Mulls Foreign Phase I, II Tests Proof Of Local Trial Worthiness (PharmAsia-$)
  • China: Fake Vaccines And Blood Medications Made With Dyed Water In Re-Used Containers (Safe Medicines)

US: Pharmaceuticals/Biotechnology

  • First five agents selected for lung cancer initiative (BioCentury)
  • With New Study, Scientists Try To Drag Drug Trials Into DNA Age (Forbes)
  • Senate Prepares to Take up Drug Quality and Security Act (Bill)
  • Iclusig Deaths Won't Stall FDA's Speedier Drug Approvals (Law 360-$)
  • Post-DoJ settlement, GlaxoSmithKline toes the line in Breo launch (Fierce) (Bloomberg)
  • Sanofi Sues FDA to Prevent Disclosure of OTC NASACORT Labeling Before Product Launch; Claims FOIA Exemption 4 (FDA Law Blog)
  • New Roche leukemia drug shows clear advantage over Rituxan: study (Reuters) (Roche) (SCRIP-$) (Pharma Letter-$) (The Street) (Fierce) (BioCentury)
  • FDA, Canadian Regulators Join Forces To Curb Illegal Pharmacies (IHP-$)
  • Remediation to continue through 2014 at Hospira's Rocky Mount (In-Pharma)
  • Overview of the Innovation in Medical Evidence Development and Surveillance (IMEDS) Program (Brookings)
  • Travelers Receives Sharp Rebuke In Heparin Discovery Fight (Law 360-$)
  • Sisters claim HPV vaccine led ovaries to stop making eggs (CBS)

US: Pharmaceuticals and Biotechnology: General

  • Rules to Require Equal Coverage for Mental Illness (NYTimes)

US: Medical Devices

  • Medtronic wins FDA nod to use software with competitors' tech (Fierce) (Mass Device)
  • Oral Argument in Medtronic Inc. v. Boston Scientific Corp. (Patent Docs)
  • EpiPen makers pay $625K to state over 'misleading' TV ads (BioFlash)
  • Medtech analyst chides Erin Brockovich's crusade against Bayer's birth control implant (Mass Device)
  • Topera Announces FDA Clearance and Commercial Availability of The FIRMap Catheter and RhythmView 3D Mapping Workstation (Press)
  • EndoShape Receives 510(k) Clearance for Polymer Embolization Device (Press)
  • FDA Approves Aptima HPV 16 18/45 Genotype Assay for Use on Hologic's Panther System (Press)

US: Dietary Supplements

  • FDA Needs Rule Change For DMAA Crackdown, Suit Says (Law 360-$)
  • USPlabs to Eliminate Aegeline from Supplements amid Hepatitis Probe (NPI)
  • Contamination & substitution present in many herbal products, but is DNA barcoding of herbals fit for purpose? (Nutra-Ingredients)

US: Assorted And Government

  • Regulations.Gov Knocked Out for More than 24 Hours (The Hill)
  • FDA's lost $85 million in users fees so far due to sequestration, OMB says (Mass Device)

Upcoming Meetings And Events

  • 8 November 2013: Ear, Nose and Throat Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 13 November 2013: Peripheral and Central Nervous System Drugs Advisory Committee Meeting (FDA)
  • 13 November 2013: Vaccines and Related Biological Products Advisory Committee Meeting (FDA)
  • 14 November 2013: Peripheral and Central Nervous System Drugs Advisory Committee Meeting (FDA)
  • 19 November 2013: Endocrinologic and Metabolic Drugs Advisory Committee Meeting (FDA)
  • 2-3 December 2013: AHWP/RAPS Joint Conference in Malasia (RAPS)
  • 9 December 2013: Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee (FDA)
  • 11 December 2013: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • EU agency questions AstraZeneca over heart drug trial (Reuters) (Pharmafile)
  • EMA Publishes New PRAC  Meeting Highlights, Recommendations (EMA)
  • PRAC recommends using acipimox only as additional or alternative treatment to lower high triglyceride levels (EMA)
  • PRAC recommends suspension of diacerein-containing medicines (EMA)
  • Briefing meetings of the EMA Innovation Task Force now open to veterinary medicines (EMA)
  • Seventh Sense wins European approval for 'painless' blood collection device (BioFlash)

Asia

  • Drug regulator asks Sun Pharma to halt clinical research at Mumbai laboratory (India Times)
  • India Mulls Foreign Phase I, II Tests Proof Of Local Trial Worthiness (PharmAsia-$)
  • China smooths registration path for more Class II devices (Clinica-$)
  • China: Fake Vaccines And Blood Medications Made With Dyed Water In Re-Used Containers (Safe Medicines)

Other International

  • S. Africa pledges action on compulsory licenses, parallel imports (Pharma Times)

General Regulatory And Interesting Articles

  • 'Jaw-dropping' breakthrough hailed as landmark in fight against hereditary diseases as Crispr technique heralds genetic revolution (Independent)
  • Allergy shots during pregnancy may decrease allergies in children (EurekAlert)
  • Oral allergy syndrome and high blood pressure medications can create lethal cocktail (EurekAlert)
  • ACE Inhibitors may Cause Kidney Damage (MedIndia)

Regulatory Reconnaissance #198 – 8 November 2013

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.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.




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