Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Device Company’s Regulatory Staff Plead Guilty to FDA Fraud (7 March 2014

Regulatory Reconnaissance: Device Company’s Regulatory Staff Plead Guilty to FDA Fraud (7 March 2014)

Posted 07 March 2014 | By Alexander Gaffney, RAC

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In Focus: US

  • Valor Medical and execs plead guilty to concealing device toxicity from FDA (Mass Device)
  • India pitches for review of US pharma whistle blower policy (India Times)
  • Generic Labeling Reg: FDA Will Change Brand Simultaneously (Pink Sheet Daily-$)
  • J&J Antibacterial Drug Risky For Pneumonia Patients: FDA (Law 360-$) (FDA) (MedPage Today) (FDA)
  • FDA Rejects Sunscreen TEAs, Plans Public Hearing On Ingredient Review (Tan Sheet-$)
  • Boehringer commits $450m extra to fix empagliflozin plant after FDA criticism (In-Pharma)
  • FDA chief calls for more regulatory collaboration and capacity building 'wherever it's needed' (SCRIP-$)
  • Sen. Grassley Seeks More Documents From Northwestern On Edwards' Valve Inquiry (Gray Sheet-$)

In Focus: International

  • Conditional EU approval for J&J's bedaquiline (BioCentury)
  • EMA Warns on Potential of Zolpidem to Cause Impaired Driving and Reduced Alertness (EMA)
  • PRAC recommends restricting use of domperidone (EMA)
  • PRAC re-examines diacerein and recommends that it remain available with restrictions (EMA)

US: Pharmaceuticals/Biotechnology

  • India pitches for review of US pharma whistle blower policy (India Times)
  • Generic Labeling Reg: FDA Will Change Brand Simultaneously (Pink Sheet Daily-$)
  • J&J Antibacterial Drug Risky For Pneumonia Patients: FDA (Law 360-$) (FDA) (MedPage Today) (FDA)
  • Endo Pharmaceuticals - Not Your Typical Off-Label Settlement (FDA Law Blog)
  • FDA Rejects Sunscreen TEAs, Plans Public Hearing On Ingredient Review (Tan Sheet-$)
  • Boehringer commits $450m extra to fix empagliflozin plant after FDA criticism (In-Pharma)
  • AstraZeneca Says Nexium Safe With Product From Ranbaxy (Bloomberg)
  • OGD Update Presentation on GDUFA (FDA)
  • US FDA chief calls for more regulatory collaboration and capacity building 'wherever it's needed' (SCRIP-$)
  • J&J Settles with Montana for $5.9M (AP)
  • FDA holding workshop on sequencing to identify microbes (BioCentury) (FDA)
  • GSK tops drug approval rates (Pharmafile)
  • Pfizer recalls depression drug in US (Press) (PMLive)
  • In Defense Of "Me-Too" Drugs: Is Primary Care Losing Out To Rare Disease R&D? (RPM Report-$)
  • Pharmacies Fear Tort Fallout From New Drug Labeling Rule (Law 360-$) (IHP-$)
  • $100M Deal In Meningitis Outbreak MDL Nears Finish Line (Law 360-$)
  • Zero to hero: the peculiar case of Orphacol (SCRIP-$)

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

  • Novartis drug Jakavi seen as blockbuster after positive data (Reuters)
  • Sangamo Surges to 13-Year High on HIV Therapy Results (Bloomberg)
  • BI's faldaprevir under FDA review in HCV; firm halts deleobuvir development (SCRIP-$)
  • Pluristem's Commercial Scale Cell Manufacturing Process Approved by FDA (Press)
  • Incyte Announces Positive Top-Line Results from Phase III Study of Ruxolitinib in Patients with Polycythemia Vera (Press)

US: Pharmaceuticals and Biotechnology: General

  • USPTO updates guidance to determine eligibility of claims (BioCentury) (USPTO Guidance)
  • New hemophilia drugs aim to simplify treatment (Reuters)
  • Experts: Officials missed signs of prescription drug crackdown's effect on heroin use (Washington Post)
  • Partnerships Open New Windows for Treatment Development (PhRMA)
  • Medicare Part D Proposed Rule: Where Did Things Go Wrong? (Health Affairs)

US: Medical Devices

  • Valor Medical and execs plead guilty to concealing device toxicity from FDA (Mass Device)
  • Sen. Grassley Seeks More Documents From Northwestern On Edwards' Valve Inquiry (Gray Sheet-$)
  • Class 1 Recalls for Philip's Trilogy Ventilators (FDA)  and Greatbatch Medical's Standard Offset Cups (FDA)

US: Dietary Supplements

  • If you read just one Pro Se legal filing based on an FDA Warning Letter today… (Above the Law)

US: Assorted And Government

  • FDA official says cosmetics industry is trying to undercut government's authority (Washington Post)
  • Enforcement Report - Week of March 5, 2014 (FDA)

Europe

  • Conditional EU approval for J&J's bedaquiline (BioCentury)
  • EMA Warns on Potential of Zolpidem to Cause Impaired Driving and Reduced Alertness (EMA)
  • PRAC recommends restricting use of domperidone (EMA)
  • PRAC re-examines diacerein and recommends that it remain available with restrictions (EMA)
  • Interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU (EMA)
  • Novartis' dermatology plans advance with Xolair approval (PMLive)
  • Medtronic Wins Key Transcatheter Valve Patent Ruling In Europe (Gray Sheet-$)

Other International

  • Australia: Upgraded over-the-counter medicines online application system (TGA)

General Regulatory And Interesting Articles

  • The dawning of the age of genomic medicine, finally (Reuters)

Regulatory Reconnaissance #271 - 7 March 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.

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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