Regulatory Focus™ > News Articles > Regulatory Reconnaissance (16 May 2013)

Regulatory Reconnaissance (16 May 2013)

Posted 16 May 2013 | By Alexander Gaffney, RAC 

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

In Focus: Special Edition

  • Dirty Medicine: The Epic Story of Criminal Fraud at Ranbaxy (Fortune)
  • Editor's Note: Every so often, there is a story that everyone in the regulatory profession needs to read. Without question, this is such a story.

In Focus: US

In Focus: International

  • Compatibility Remains Challenge for UDI Database in the EU (Medtech Insider)
  • Prosecutors want jail time, fine for disgraced PIP CEO (Fierce Medical Devices)
  • Italian Regulators: We're not Defenders of Industry's Interests (AIFA) (GAIA News)
  • Update on the Proposed Changes to the Medical Device Regulatory System in the EU (Medical Devices Legal)
  • India: Patents and precedents - Will India's Patent Battles Inspire Others? (Financial Times)
  • Counterfeit Condom Ring In China: Police Seize Millions Of Fake Contraceptives (Medical Daily)

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

US

Pharmaceuticals/Biotechnology
  • Dirty Medicine: The Epic Story of Criminal Fraud at Ranbaxy (CNN Money)
  • Warning didn't change for-profit dialysis drug use (Reuters)
  • Track and Trace Bill Passes House Committee (E&C) (The Hill) (Matheson) (BioCentury) (The Pink Sheet)
  • ADUFA/AGDUFA Bills Pass House by Voice Vote (E&C) (Upton)
  • Senate Schedules Hearing on Compounding Legislation, Track and Trace (HELP) (Statement) (2) (Bennet) (In-Pharma Technologist) (BioCentury)
  • Senate Pharmaceutical Compounding Bill (Congress)
  • Senate Track and Trace Bill (Congress)
  • New Bill Would Require Drugs to Contain a Statement Regarding Whether they Contain a Starch- or Grain-Derived Material (Congress) (Congress)
  • Roche submits obinutuzumab applications (BioCentury) (Pharma Times)
  • Fecal Transplant: FDA Wants Regulation (MedPage Today) (FDA News)
  • Report says U.S. lags behind other nations in biosimilars (Healthcare Packaging)
  • FDA Releases 483s for Hospira, American National Red Cross, and Andrx Pharmaceutical (FDA) (FDA) (FDA)
  • Washington Legal Foundation: Sunshine Law's Treatment of Medical Textbooks Violates First Amendment (WLF)
  • FDA Tells DC Circuit Court That KV Drug Compounding Wasn't A Priortity (Law 360)
  • Comments on FDA's Docket Regarding its PDUFA Benefit-Risk Plan (FDA Docket)
  • Sen. Moran Introduces Veterinary Medicine Mobility Act (Moran)
  • Opinion: Aveo Screwed Up but Its Kidney Cancer Drug Is Real (The Street)
  • Mylan, Glenmark and Apotex all Obtain FDA Approval for Generic Zolmitriptan Tablets (PR Newswire) (FDA)
ASCO Roundup
Medical Devices
  • Hospira hit with another FDA warning letter over pumps (Fierce Medical Devices)
  • MiE's PET SCINTRON Receives FDA Clearance (PR Newswire)
  • Inside 'Case For Quality' Forum: FDA Ponders 'Critical-To-Quality' Inspectional Approach (The Silver Sheet)
  • AdvaMed Comments on Two Draft Guidance Documents-Infusion Pumps and MCMs (FDA Docket) (2)
  • Colgate Is Trying to Patent Caffeinated Toothbrushes (Vice)
  • iPhone Placebo Effect app hopes to change patient behavior (MobiHealthNews)
  • Maquet's Class I ventilator battery recall affects 90k units (Mass Device)
  • FDA's Latest Post-Market Plan: Data-Mining Device Safety … And Then There's MAUDE (The Silver Sheet)
  • Class 1 Recall: Cook Medical's  Zilver PTX Drug-Eluting Peripheral Stent (FDA) (FDA)
Assorted and Government
  • FDA to Industry: Track our FDASIA Progress (FDA)
  • Upcoming Brookings/FDA Webinar: Active Medical Product Surveillance Roundtable (FDA)
  • FDA Deploys Section 301(ll) in Battle Against DMAA (FDA Law Blog)
  • Reagan-Udall Foundation Wants to Add Three More Board Members (RU)
  • Enforcement Report - Week of May 15, 2013 (FDA)
  • FDA: Adverse event reporting is valued information (FDA)
  • CMS Gets a Permanent Chief-The First One in Seven Years (NYTimes) (MedPage Today) (Washington Post) (Kaiser)
  • NIMH Director Says The Bible Of Psychiatry Is Valid, After All (Pharmalot)
  • This Will be the First Summer FDA's Sunscreen Labeling Rules are in Effect (FDA)
  • Video: Closure of Supplement Manufacturer Kabco Shows FDA's Power (Natural Products Insider)
  • Special focus: Recent FDA warning letters offer important lessons for companies (Nutra Ingredients USA)
  • FDA Seeks Ferrets for a PrEP Study (FDA)
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)
  • 22 May 2013: Markup of Senate Compounding, Track and Trace Legislation (HELP)
  • 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)
  • 23 May 2013: Reagan-Udall Foundation Annual Open Public Meeting (RU)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (FDA)

International

  • Compatibility Remains Challenge for UDI Database in the EU (Medtech Insider)
  • Prosecutors want jail time, fine for disgraced PIP CEO (Fierce Medical Devices)
  • Italian Regulators: We're not Defenders of Industry's Interests (AIFA) (GAIA News)
  • Update on the Proposed Changes to the Medical Device Regulatory System in the EU (Medical Devices Legal)
  • India: Patents and precedents - Will India's Patent Battles Inspire Others? (Financial Times)
  • Australia Says it Has Found No New Problems With Gardasil Vaccine Since 2010 (TGA)
  • J&J Gets A Shot In The Arm From WHO Over Vaccine Deaths (Pharmalot)
  • Counterfeit Condom Ring In China: Police Seize Millions Of Fake Contraceptives (Medical Daily)
  • As New Biosimilars Roll Out, Indian Biotech Group Raises Quality Concerns (PharmAsia News)
  • U.S. Group Wants India Removed From Import-Preference List Over CL Use (PharmAsia News)
  • Europe must pay its way for innovation: Novo chief (Pharma Times)
  • Police confiscate smuggled secondhand medical devices in China (Shanghai Daily)
  • Placebos: Banned in Helsinki? (Placebo Control)
  • British maker of death penalty drugs adds new restrictions for US buyers (The Guardian)
  • CircuLite Receives Approval to Begin CE Mark Trial for SYNERGY IC Circulatory Support System (Business Wire)
  • Devon's extriCARE Negative Pressure Wound Therapy CE Marked (Medgadget)
  • European Medicines Agency closed 20 May 2013 (EMA)

General Regulatory and Interesting Articles

  • Scientists Clone Human Embryos To Make Stem Cells (NPR) (NPR) (NYTimes)
  • Tissue damage from metal-on-metal hip implants appears before pain symptoms appear (EurekAlert)
  • Why Does a Rhino Horn Cost $300,000? Because Vietnam Thinks It Cures Cancer and Hangovers (The Atlantic)
  • Psychiatrists, critics face off over psychiatric manual (NBC)

Regulatory Reconnaissance #68 - 16 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 news@raps.org.


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