Regulatory Reconnaissance (14 May 2013)

Posted 14 May 2013 | By Alexander Gaffney, RAC 

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

In Focus: US

In Focus: International

  • French competition body fines Sanofi in Plavix dispute (Bloomberg) (Reuters)
  • Indian Biotech Lobby Fears Cipla's Biosimilar Drug Wasn't Approved Properly (India Times)
  • SCENIHR Calls for Risk Assessment of Synthetic Biology (EU)
  • Hospital to Probe Alleged Ethical Lapses in East German Medical Trials (AP)

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  • US Government Files Morning-After Pill Appeal (AP) (WSJ) (CBS) (The Hill) (SCOTUS Blog)
  • Drug Shortages Not Going Away (Med Page Today)
  • Class action suits pile up at Aveo's doorstep in wake of FDA debacle (Fierce Biotech) (BioSpace)
  • Novartis Scrambles To Woo Vets Angry Over Production Problems (Pharmalot)
  • Pfizer Has Second Recall of Thyroid-Disorder Drug Levoxyl (NASDAQ)
  • U.S. FDA Grants Priority Review to Simeprevir (TMC435) for Combination Treatment of Genotype 1 Chronic Hepatitis C (J&J)
  • FDA Accepts Biogen Idec's BLA for Long-Lasting Factor VIII Therapy for Hemophilia A (Business Wire) (BioCentury) (SCRIP Intelligence)
  • Senators prod FDA over hydrocodone schedule (The Register Herald)
  • Medivir: U.S. FDA grants priority review to Simeprevir for combination treatment of genotype 1 chronic hepatitis C (PR Newswire) (SCRIP Intelligence)
  • Actavis' NDA for Progestin-Only Patch Accepted for Filing by FDA (PR Newswire)
  • Arbor Pharmaceuticals Announces FDA Approval of First NDA (PR Newswire)
  • FDA Approves PAI Pharmaceuticals' Hydrocodone Bitartrate (ANDA #040838) (FDA)
  • Invacare Corporation Receives FDA Acceptance of First Certification Audit Related to Consent Decree (Business Wire)
  • CDER Releases Internal Staff Documents on Conducting Teleconferences (FDA)
  • An Industry Protection Bill Concealed Under The Veil Of Patient Protection (RxTrace)
  • FDA delivers crushing blows to abuse-deterrent opioids (EP Vantage)
  • Huge drug cost disparities seen in health overhaul (AP)
  • FDA move gives Purdue edge in painkiller market (MM&M)
  • Does the National Childhood Vaccine Injury Compensation Program Need to be Updated? A Former Rep Says it Does (Roll Call)
  • Novartis Tells High Court State Punitive Awards Are Illegal (Law 360)
  • N.J. law designed to address prescription eye drop adherence (DSN)
  • USP Launches Initiative to Fight Counterfeit Drugs in Sub-Saharan Africa (Biopharm International)
  • Missed Warnings on Cold Medicine For Children (WSJ)
  • Opinion: White House Limits on Plan B Put Science in Backseat (Scientific American)
  • Proactive Compliance: Putting the "P" in CAPA (Pharma Manufacturing)
Medical Devices
  • FDA med device chief pledges 'no more Columbo moments' (Minneapolis Biz Journal)
  • C.R. Bard Inc. to Pay U.S. $48.26 Million to Resolve False Claims Act Claims (DOJ) (Reuters)
  • Biolase gets FDA nod for new tissue laser (Mass Device)
  • Public Citizen, Others Comment on new PMA Requirements for Four Class III devices for Treatment of Poisoning and Drug Overdoses (FDA Docket)
  • OMB Signs off on HDE Exemption Application Requirements (OMB)
  • Comments come in on CDRH's Experiential Learning Program (FDA Docket)
  • Transcript: FDA Meeting of the Opthalmic Devices Panel (8 April 2013) (FDA)
  • Here's How The First FDA-Approved Bionic Eye Works (Business Insider)
Assorted and Government
Upcoming Meetings and Events
  • 14-15 May 2013: E&C Committee to Markup ADUFA/ADGDUFA User Fee Bills (E&C)
  • 14-15 May 2013: E&C Committee to Markup Pharmaceutical Track and Trace Legislation (E&C)
  • 16 May 2013: OPDP Enfocement Actions Webinar (FDA)
  • 17 May 2013: NCATS Meeting (NCATS)
  • 21-22 May 2013: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee (FDA)
  • 22 May 2013: Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (FDA)
  • 22 May 2013: CVM's New Animal Drugs for Use in Feeds Workshop (FDA)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (FDA)


  • French competition body fines Sanofi in Plavix dispute (Bloomberg) (Reuters)
  • Indian Biotech Lobby Fears Cipla's Biosimilar Drug Wasn't Approved Properly (India Times)
  • SCENIHR Calls for Risk Assessment of Synthetic Biology (EU)
  • EU body calls for closer IVD/pharma link-up in CDx (Clinica)
  • Another recall for Johnson & Johnson Down Under (Mass Device)
  • GE Recalls its Drytec Generator in the UK Due to Sterility Concerns (MHRA)
  • Hospital to Probe East German Medical Trials (AP)
  • Department of Health responds to paper on PIP breast implants published in the Journal of the Royal Society of Medicine (MHRA)
  • EMA Report on its Medication-errors Workshop (EMA)
  • TGA Opens Two Consultations on Product Information, Changes to Premarket Assessment for Devices (TGA) (TGA)
  • TGA Releases Guides on Making Minor Variations to Registered Prescription Medicines (TGA) (TGA)
  • NIHR streamlines clinical trials service for pharma (PMLive)
  • Reverse Medical Corporation Announces CE Mark and Initial Clinical Experience with the MVP™ Micro Vascular Plug for Peripheral Embolization (Business Wire)

General Regulatory and Interesting Articles

  • Renaissance in new drugs for rare diseases: Report (EurekAlert)
  • Breakthrough in how pancreatic cancer cells ingest nutrients points to new drug target (EurekAlert)

Regulatory Reconnaissance #66 - 14 May 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

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