Regulatory Focus™ > News Articles > Regulatory Reconnaissance (3 October 2013)

Regulatory Reconnaissance (3 October 2013)

Posted 03 October 2013 | By Alexander Gaffney, RAC 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Tips? Gripes? Let me know: news@raps.org.

In Focus: US

  • Impact of Shutdown on FDA Depends on How Long It Lasts (BioWorld)
  • Biosimilars Guidance, Drugmaker Grades Coming, FDA Says (Law 360-$)
  • Mass. lawmakers OK compounding pharmacy crackdown (Boston Herald)
  • Time to Tighten Your Belts and Pay Attention to Quality (Lachman)
  • Why Investors Need to Know Basic Regulatory Definitions: The Case of Delcath (The Street)

In Focus: International

  • French watchdog 'did not act fast enough on faulty PIP breast implants' (The Guardian)
  • EMA Plans Meeting on Electronic Submission Standards (EMA)
  • Japan's PMDA Collecting Adverse Event Reports Directly From Patients (PharmAsia-$)
  • Novartis sees limited impact from Japan Diovan scandal (Reuters)
  • Indian pharma company in dock over fake medicines in Ghana (India Times)

Comments? Suggestions? Email me at news@raps.org.

US: Pharmaceuticals/Biotechnology

  • Impact of Shutdown on FDA Depends on How Long It Lasts (BioWorld)
  • Biosimilars Guidance, Drugmaker Grades Coming, FDA Says (Law 360-$)
  • Mass. lawmakers OK compounding pharmacy crackdown (Boston Herald)
  • Time to Tighten Your Belts and Pay Attention to Quality (Lachman)
  • Amarin Informed by FDA That October 16th Advisory Committee Meeting Will Take Place as Scheduled (Press)
  • Delcath Gets Special FDA Designation for Therapy (PharmPro) (DD&D)
  • Why Investors Need to Know Basic Regulatory Definitions: The Case of Delcath (The Street)
  • FDA, EMA accept Omeros ophthalmology drug applications; shares soar (SCRIP-$) (BioCentury)
  • Pharma Controls Clinical Trials Of Their Drugs. Is This Hazardous To Your Health? (Forbes)
  • Zogenix rises on anticipated FDA Zohydro action (SCRIP-$) (BioCentury)
  • FDA OKs Stem Cell Trial for Spinal Cord Injuries (DD&D)

US: Pharmaceuticals and Biotechnology: General

  • Victims of tainted drug face long wait for relief (Boston Globe)
  • Texas: State Bought Execution Drugs From a Compounding Pharmacy (NYTimes)
  • Why Good Doctors Prescribe Off-Label Treatments (Pacific Standard)

US: Medical Devices

  • Valeant Pharmaceuticals' Bausch + Lomb Receives U.S. FDA Clearance For Novel Monthly Disposable Contact Lens (Press)
  • Precision Spine Announces Expanded FDA 510(k) Clearance For the Reform Pedicle Screw System (Press)
  • Nucletron, an Elekta Company, Receives U.S. FDA 510(k) Clearance for Esteya Electronic Brachytherapy System for Treating Skin Cancer (Press)

US: Assorted And Government

  • On Day 3 of Shutdown, Neither Side Budging in Budget Standoff (NYTimes)
  • From Therapy Dogs To New Patients, Federal Shutdown Hits NIH (NPR) (GHIT)
  • FDA: The Growing Use of Freedom of Information Act Requests for FDA Data by Life Science Stock Traders (Policy and Medicine)
  • Dietary supplement industry says "no" to more information for consumers (again) (Science-Based Medicine)
  • An Old Fashioned Park Criminal Prosecution With Some Twists (FDA Law Blog)
  • Can a corporation be liable for "violating" an ambiguous regulation? (Inside Counsel)
  • Synthetic versions of natural ingredients with NDI notifications crop up in marketplace (Nutra Ingredients)

Upcoming Meetings And Events

  • October 8-9, 2013: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 9-10 October 2013: AAMI/FDA Summit on Healthcare Technology in Nonclinical Settings (AAMI)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • French watchdog 'did not act fast enough on faulty PIP breast implants' (The Guardian)
  • EMA Plans Meeting on Electronic Submission Standards (EMA)
  • Orexigen Files MAA for Weight Loss Pill Contrave (Press)
  • EMA board to meet on transparency (BioCentury)
  • Eisai Receives European Commission Approval On Use Of Antiepileptic Agent Zonegran In Pediatric Patients (Eisai)
  • Shire aims to win skeptical Europe over to ADHD drugs (Fierce)

Asia

  • Japan's PMDA Collecting Adverse Event Reports Directly From Patients (PharmAsia-$)
  • Novartis sees limited impact from Japan Diovan scandal (Reuters)
  • Indian pharma company in dock over fake medicines in Ghana (India Times)
  • Indian Supreme Court seeks more oversight of DCGI's clinical trial approvals (In-Pharma) (SCRIP-$)
  • MHLW Japan Orders Tanabe Mitsubishi To Improve, Shuts Down Bipha For 30 Days For Not Reporting Additive (PharmAsia-$)

Other International

  • Upcoming WHO Meeting Seeks to Confront Problem of Counterfeits (IRIN)

Regulatory Reconnaissance #170 - 3 October 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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