Device News Digest - Mar 29

	FDA makes Vascular Solutions' catheter valve recall Class I The recall of hemostasis valves made by Vascular Solutions is deemed Class I, the most serious category, by the FDA. The FDA slapped its most seri ... March 28, 2013 -- MassDevice
	Biotronik lands CE Mark for MRI-safe Iforia defibrillator German medical device company Biotronik says European regulators granted CE Mark approval for its Iforia MRI-safe defibrillator. Biotronik said it ... March 28, 2013 -- MassDevice
	A Chinese Hearing Implant Takes Aim at Cochlear After suddenly going deaf at age 30, Ke Liu, a civil servant in China's eastern Jiangxi province, didn't have many options. A cochlear implant mig ... March 28, 2013 -- BusinessWeek
	Sensing the winds shifting, Medtronic applauds efforts to repeal the device tax Even as companies like Boston Scientific and Stryker and smaller ones like Cook Medical have complained loudly about the medical device tax, Medtr ... March 28, 2013 -- Medical Device & Diagnostic Industry
	Covidien Nets $177M From J&J Unit In Scalpel Patent Suit A Connecticut federal judge on Thursday awarded medical supplier Covidien PLC $176.5 million in damages after finding that Johnson & Johnson unit ... March 29, 2013 -- Law360

GRC News Update - Mar 29

	DOJ Declines to Prosecute DynCorp Over FCPA Allegations Among the reasons DynCorp gave for the declination to prosecute in the filing were the voluntary disclosure it made, an internal probe and steps t ... March 29, 2013 -- Corruption Currents
	Morgan Stanley CEO's Compensation in 2012 Fell 18% Under SEC Pay Rules Morgan Stanley (MS) Chairman and Chief Executive James Gorman took home $10.7 million in annual compensation in 2012, down 18% from the prior year ... March 28, 2013 -- FOXBusiness.com
	SAC Judge Questions Record $602 Million SEC Settlement SAC Capital Advisors LP will have to wait to learn if its $602 million insider trading settlement with the Securities and Exchange Commission can ... March 28, 2013 -- BusinessWeek
	TeliaSonera Could Face Fines in Uzbekistan Bribery Case Sweden-based telecommunications company TeliaSonera AB received notice from Swedish prosecutors it could face fines and possible forfeiture relate ... March 28, 2013 -- Corruption Currents
	Minnesota Tech Firm Opens FCPA Probe Technology company Image Sensing Systems Inc. said Wednesday it is investigating itself for possible violations of anti-corruption laws in the U.S ... March 29, 2013 -- Corruption Currents

Device News Digest - Mar 28

New Guidelines for Weight-Loss Surgery Upgrade Sleeve Procedure Note that these new bariatric surgery guidelines should lead to increased use of gastric sleeves. In addition, the guidelines suggest that bariatr ... March 27, 2013 -- MedPage Today

Medical device tax: New confidence in repeal following symbolic Senate vote Opponents of the medical device tax aim to leverage a largely symbolic Senate vote to generate momentum toward repeal. When the Senate voted this ... March 27, 2013 -- MassDevice

Doctor-Owned Device Suppliers Deemed Inherently Suspect Doctor-owned businesses that act as middlemen between medical device makers and hospitals are "inherently suspect" and some of their practices may ... March 26, 2013 -- BusinessWeek

Selecting medical device interconnects

Technology advances in electronic consumer devices and the telecommunications industry are converging at a rapid rate with medical device technology. For example, the medical industry now embraces membrane switches from the appliance industry and relies on mobile phone interconnects within portable medical monitoring devices. In addition, super-precise surgical tools have been further improved by combining advanced fiber optic and interconnect design technologies

In this article published in http://www.eetimes.com there is a detailed explanation on this subject . click here to read full

GRC News Digest - Mar 28

	JPMorgan Tells SEC New VaR Model Didn’t Require Prior Disclosure JPMorgan Chase & Co. (JPM), facing criticism that it misled investors about a change to a risk model as trades backfired last year, told U.S. regu ... March 28, 2013 -- Bloomberg
	Chevron says executive pay to reflect 2012 "incidents" Chevron Corp said on Wednesday its executive pay would reflect certain incidents in 2012 as well as a financial performance that outpaced the U.S. ... March 27, 2013 -- Reuters
	DOJ Watchdog Says FBI Could Improve Terrorism Finance Case Management The Federal Bureau of Investigation didn't always detail the efforts it made to pursue financial angles of terrorism cases, according to a report ... March 27, 2013 -- Corruption Currents
	Thiam’s $35.5 Billion Secret Deal Ignites U.K. Regulator’s Wrath On Feb. 12, 2010, Prudential Plc (PRU) Chief Executive Officer Tidjane Thiam offered $35.5 billion for AIA Group Ltd. (1299) in what would have be ... March 28, 2013 -- Bloomberg
	Sanctions make it harder for Koreans to help their own When the now elderly man left Japan on a Soviet ship in 1960 for North Korea, he thought he was headed to the promised land. In reality, he surviv ... March 28, 2013 -- Reuters
•	Australia ends interbank rate-setting panel after Libor scandal
•	U.K. Should Abandon Executive Pay Benchmarks, Pension Group Says

Top FDA compliance seminars April 2013 - Sponsored Posting

Statistical Considerations for ICH Guidelines - Apr 11/12 MN

Statistical Techniques for Medical Device Manufacturers - Apr 17/18 TX

Why is FDA at my facility, and what do I do during an inspection? - Apr 18/19 Chicago

Medical Device Labeling (In-Vitro Lab “Home Brew” off - Label Guidance & Enforcement) - Apr 18/19 Chicago

Latin America: Regulatory Compliance Requirements for Life Science Products (Focus: Brazil, Mexico, Argentina) - Apr 25/26 LA

Computer System Validation - Reduce Costs and Avoid 483s - Apr 25-26 Las Vegas

Top 10 risks and opportunities for global organizations. Published by E&Y.

1. Regulation and compliance
2. Cost cutting
3. Managing talent
4. Pricing pressure
5. Emerging technologies
6. Market risks
7. Expansion of government's role
8. Slow recovery/double-dip recession
9. Social acceptance risk/CSR
10. Access to credit

In this report,  the global top 10 business risks and opportunities emerging from it is explored. As in previous years, it has been taken a “bottom-up” approach to the work, gathering opinions from leading industry-based and academic commentators, across seven global sector groups.

This comprised a large-sample survey of companies and governments in 15 countries in order to rank the risks and opportunities, obtain forecasts on whether these challenges would be more or less important in 2013, and discover how leading organizations in each of the seven sectors are responding to these challenges.

The research suggests that regulation and compliance continues to be the biggest overall risk. In fact, four out of the seven sectors we surveyed ranked this as number ranking, although many respondents indicated steps taken to mitigate these risks have been reasonably effective. 

With regard to opportunities, improving execution of strategy across business functions was ranked number one overall. Looking across the sectors, the impact of this opportunity is uniformly high in all cases. Investing in processes, tools and training to achieve greater productivity was ranked second overall. However, individual sectors and countries vary widely in the relative importance they give to this opportunity

Read The full report

Top 5 global risks of 2013 - World Economic forum

In a report published by global economic forum the top five risks for 2013 are

1. Severe income disparity
2. Chronic scal imbalances
3. Rising greenhouse gas emissions
4. Water supply crises
5. Mismanagement of population ageing

The top 5 impacts due to these risks are 

1. Major systemic fi nancial failure
2. Water supply crises
3. Chronic scal imbalances
4. Failure of climate change adaptation
5. Di usion of weapons of mass destruction

The World Economic Forum’s Global Risks 2013 report is developed from an annual survey of over 1,000 experts from industry, government, academia and civil society who were asked to review a landscape of 50 

global risks.

The global risk that respondents rated most likely to manifest over the next 10 years is severe income disparity, while the risk rated as having the highest impact if it were to manifest is major systemic financial failure. There are also two risks appearing in the top five of both impact and likelihood – chronic fiscal 

imbalances and water supply crisis.

Read The full Report

Device News Digest - Mar 27

	Doctor-Owned Device Suppliers Deemed Inherently Suspect Doctor-owned businesses that act as middlemen between medical device makers and hospitals are "inherently suspect" and some of their practices may ... March 26, 2013 -- BusinessWeek
	Intuitive Surgical Loses Bid to Throw Out Robot Lawsuit Intuitive Surgical Inc. (ISRG) lost a bid to have all claims dismissed in a lawsuit filed against it in Washington state court over damages allege ... March 26, 2013 -- Bloomberg
	FDA approves Medicrea PASS LP system for adolescent idiopathic scoliosis treatment The US Food and Drug Administration (FDA) has granted regulatory approval to Medicrea group's PASS LP system for the treatment of adolescent idiop ... March 26, 2013 -- Medical Devices Business Review
	BioControl Medical makes progress toward FDA review for CardioFit heart stim device The FDA approves the 3rd and largest phase of BioControl Medical's investigational device exemption trial of the CardioFit vagal nerve stimulation ... March 26, 2013 -- MassDevice
•	GE Healthcare wins FDA OK for new imaging dye, loses $5M jury decision over old dye

GRC Digest - Mar 27

	DealBook: Federal Reserve Faults Citigroup Over Money Laundering Controls The Federal Reserve took aim at Citigroup and the American branch of its Mexican subsidiary over failure to monitor cash transactions for potentia ... March 26, 2013 -- NYT > Business
	Cyprus Capital Controls First in EU Could Last Years Cyprus is on the verge of an unprecedented financial experiment: imposing controls on money transfers in an economy that doesn't have its own curr ... March 27, 2013 -- Bloomberg
	DuPont and Monsanto Agree to End Lawsuits Monsanto Co. (MON) and DuPont Co. (DD), the world's largest seed companies, agreed to drop their respective antitrust and soybean patent lawsuits ... March 26, 2013 -- Bloomberg
	Qantas-Emirates Kangaroo Alliance Backed by Antitrust Regulator Qantas Airways Ltd. (QAN)'s bid to tie up with Emirates on international flights and shift the so-called kangaroo route to fly through Dubai was c ... March 26, 2013 -- BusinessWeek
	Europe Expands Investigation Into Derivatives Market The inquiry, which has already ensnared Barclays, JPMorgan Chase and Deutsche Bank, has been broadened to include the International Swaps and Deri ... March 26, 2013 -- NYT > Business
•	Anheuser-Busch Discloses India Foreign Corruption Probe by SEC

FDA roles out RFP doc for vendors to help it monitor illicit product sales online

Mar 21 FDA has posted a RFP document. the plan here is to hire a contractor to look for a laundry list of illegal activity involving FDA-regulated products, from prescription drugs for sale online contrary to U.S. law, to the sale of stolen blood. The monitoring would cover websites that sell products, process payments, perform direct marketing or order fulfillment services, and even in some cases merely provide information online.

 the monitoring will include sifting through mounds of publicly available information on websites, online bulletin boards, chat rooms, social networks and even email spam in order to find and report websites that might be engaging in illegal trade or marketing.

Device News Digest - Mar 26

	GE Healthcare wins FDA OK for new imaging dye, loses $5M jury decision over old dye GE Healthcare touts an FDA win for its new AdreView nuclear imaging agent and vows to appeal a $5 million jury decision in favor of a patient who ... March 25, 2013 -- MassDevice
	DePuy Hip Implants Appeared To Be Safe, Surgeon Testifies A surgeon and expert witness for a woman suing Johnson & Johnson subsidiary DePuy Inc. over its recalled ASR XL metal hip testified at the Illinoi ... March 26, 2013 -- Law360
	Salesmen in the Surgical Suite A widow whose husband cried about being 'trapped' in his body after undergoing a prostatectomy that used Intuitive Surgical's da Vinci robotic sys ... March 25, 2013 -- NYT > Science
	Getting it Right the First Time: Clinical Evidence Requirements for CE Marking Preparing a Clinical Evaluation is no small task. Having it rejected by reviewers, and doing it over again to correct deficiencies is not uncommon ... March 25, 2013 -- Medical Device & Diagnostic Industry
	Type II Diabetes and Obesity are the dual targets of this non-surgical implantable medical device People suffering from Type II diabetes and related obesity may have a new medical device that addresses both the chronic conditions at the same ti ... March 25, 2013 -- Medical Device & Diagnostic Industry

GRC digest - Mar 26

	Anheuser-Busch Discloses India Foreign Corruption Probe by SEC Anheuser-Busch InBev NV (ABI)'s India joint venture is being investigated by the U.S. Securities and Exchange Commission for possible violations o ... March 25, 2013 -- Bloomberg
	Libor Rate Oversight to Be Handed to New U.K. Finance Regulator Regulatory oversight of Libor rates will be handed to the U.K. Financial Conduct Authority on April 1, under rules meant to restore credibility to ... March 25, 2013 -- BusinessWeek
	Affirmative Action Review Expanded by U.S. Supreme Court The U.S. Supreme Court expanded its scrutiny of affirmative action in higher education, agreeing to review a Michigan law that would bar public un ... March 25, 2013 -- Bloomberg
	Complex Consumer Protection Laws Keep Small Banks from Serving Unbanked Access to basic banking services allows individuals and families to build a solid financial foundation by safely granting the opportunity to condu ... March 25, 2013 -- American Banker

Drug News Digest - Mar 25

	Generic-Brand Name Drug Case Goes to Supreme Court The Supreme Court is to decide whether the maker of a brand-name drug can pay a generic-drug company to keep its version off the market. March 24, 2013 -- NYT > U.S.
	U.S. FDA approves Cangene's treatment for botulism U.S. health regulators on Friday approved the first ever antibody that can counteract the effect of all types of toxins known to cause botulism, a ... March 23, 2013 -- Reuters
	U.S. FDA suggests charging fees to pay for oversight The head of the U.S. Food and Drug Administration proposed on Friday that the agency charge fees to compounding pharmacies to pay for the oversigh ... March 22, 2013 -- Reuters
	New Botox alternative in the war on wrinkles Johnson & Johnson may soon cause frown lines at Allergan Inc, maker of Botox. J&J expects to seek U.S. approval next year for an anti-wrinkle drug ... March 24, 2013 -- Reuters
	AAN: Birth Control Tied to Blood Clots in Migraines Women who suffer from migraines, and migraines with aura in particular, may have an elevated risk of thrombotic complications when they use combin ... March 24, 2013 -- MedPage Today
•	EU new drug approval studies "have too few patients to evaluate safety"

GRC News Update Mar - 25

	Web Money Gets Laundering Rule Firms that issue or exchange the increasingly popular online cash will now be regulated in a similar manner as traditional money-order providers. March 22, 2013 -- Corruption Currents
	Deutsche Bank braced for $390 mln Iran sanctions charges-report Deutsche Bank is bracing for more than 300 million euros ($390 million) in charges linked to suspected violations of U.S. sanctions on Iran, a Ger ... March 24, 2013 -- Reuters
	Cisco Hit With $70M Jury Verdict, May Appeal Cisco Systems Inc. was ordered to pay $70 million to XpertUniverse Inc. after a federal jury ruled Friday the tech giant committed fraud during a ... March 22, 2013 -- Corruption Currents
	For J.P. Morgan, Lemons to Lemonade J.P. Morgan, the nation's largest bank by assets, added another notch on its belt, winning an award for "best crisis management," the second time ... March 22, 2013 -- WSJ.com: US Business
	Lawyer Expects Major UK Bribery Case Within 18 Months Reuters Alistair Graham, a London-based partner at Mayer Brown, predicts a high-profile prosecution under the U.K. Bribery Act within the next 18 ... March 22, 2013 -- Corruption Currents
•	Genachowski Announces Resignation as F.C.C. Chairman
•	India RBI Official Doesn't See Money Laundering by Three Banks

GRC News Digest - March 22

• India RBI Official Doesn't See Money Laundering by Three Banks

  Three Indian banks which are facing a central bank probe for possible violations of customer-verification, foreign-exchange and anti-money launder ...

  March 21, 2013

  -- FOXBusiness.com

• Standard Chartered Chairman Retracts Comments on U.S. Sanction Violations

  Standard Chartered Chairman John Peace is apologizing and retracting what he says are inaccurate comments he made about the company's U.S. sanctio ...

  March 21, 2013

  -- Corruption Currents

• Most Small Businesses Don’t Recover From Cybercrime

  Small-business owners are more vulnerable to cybercrime than they think they are, according to a new study.

  March 21, 2013

  -- Corruption Currents

• Raj Rajaratnam brother charged with insider trading

  A younger brother of Raj Rajaratnam was charged with insider trading on Thursday, nearly two years after the founder of the Galleon Group hedge fu ...

  March 21, 2013

  -- Reuters

• JPMorgan Silent Partner Revealed in Whale Fiasco

  One of the best parts about last week's Senate hearing on JPMorgan Chase & Co. (JPM)'s London Whale trades is that we finally got a clear picture ...

  March 21, 2013-- Bloomberg
  
  
  

Life Science News Digest - Mar 22

• FDA seeks to damp criticism over mobile health app proposals

  The U.S. Food and Drug Administration said its plans for regulating certain healthcare apps used on smartphones and tablets will not impose undue ...

  March 21, 2013

  -- Reuters

• U.S. Senate may back symbolic repeal of medical device tax

  Opponents of a 2.3 percent tax on medical device companies will likely win passage this week in the U.S. Senate of a largely symbolic resolution c ...

  March 21, 2013

  -- Reuters

• Ethicon lands FDA nod for cordless Enseal G2 tissue sealer

  Ethicon wins 510(k) clearance for its new cordless Enseal tissue sealer. Johnson & Johnson(NYSE:JNJ) subsidiary Ethicon won 510(k) clearance from ...

  March 21, 2013

  -- MassDevice

• MEDICREA Receives FDA Pediatric Clearance for PASS® LP Systems

  LYON, France--(Business Wire)-- The MEDICREA group (FR0004178572-ALMED), listed on Alternext by NYSE Euronext Paris, a medical company specialized ...

  March 21, 2013

  -- Reuters

• FDA Panel Votes 5-3 on Abbott Device

  A federal advisory committee narrowly said the benefits of Abbott Laboratories' Mitraclip heart device outweighed its risks.

  March 20, 2013

  -- WSJ.com: US Business

GRC News update - Mar 21

Pension Fund Attorney Indicted For Kickback Scheme After 30 years of working for the city's two pension funds, attorney Ronald Zajac was indicted today on charges he was part of a bribery and kickb ... March 20, 2013 -- Huffington Post

Bankers get one last bonus season before EU cap on payouts Bankers in Europe will have one final bonus season before they are barred from awarding themselves payouts worth more than their salary, EU lawmak ... March 20, 2013 -- Reuters

FCPA Chiefs Pat Compliance Pros on the Back Speaking at a conference for compliance officers Wednesday, the two corruption hunters said that, by and large, U.S. multinationals seem to have accepted the need for comprehensive anti-corruption controls.

Microsoft Probe Highlights Third Party Liability WSJ reported Tuesday that lawyers from the DOJ and the SEC are examining kickback allegations made by a former Microsoft representative in China, as well as the company’s relationship with certain resellers and consultants in Romania and Italy.

'Pay for Performance' No Longer a Punchline More than half of the compensation awarded to 51 CEOs last year was tied to their companies' financial or stock-market performance, according to a preliminary review of proxy statements by consulting firm Hay Group and The Wall Street Journal. In most cases, the companies must hit specified targets for the CEO to receive the promised money or equity.

GRC News Update - Mar 20

	U.S. Said to Look Into Microsoft Bribery Allegations The S.E.C. and Justice Department are investigating accusations involving the company in China, Italy and Romania, a person briefed on the matter ... March 19, 2013 -- NYT > Home Page
	American Airlines defends $20-million severance pay to CEO _ American Airlines is defending a plan to pay its departing chief executive a severance payout of nearly $20 million after the airline completes ... March 20, 2013 -- Chicago Tribune
	HP Investors Poised to Reprimand Lane for Autonomy Fiasco Hewlett-Packard Co. (HPQ) Shareholder advisers have said that the board failed to properly vet the acquisition of software maker Autonomy, and are ... March 20, 2013 -- BusinessWeek
	Cybersecurity Experts Warn Many Cos May Have Had IP Stolen AP Companies where there were breaches included large 'blue-chip' concerns,said two senior executives at Mandiant Corp. The hackers generally woul ... March 19, 2013 -- Corruption Currents
	Freddie Mac sues more than a dozen banks over Libor U.S. mortgage finance company Freddie Mac is suing more than a dozen banks for losses from the alleged manipulation of the benchmark interest rate ... March 20, 2013 -- Reuters

Drug and Device News and Blog watch Mar18-19

Wanted: FDA App Enforcement

I need help figuring this out. A pretty innovative guy named Myshkin Ingawale of Biosense Technologies, Mumbai, India two weeks ago stood in front of the audience at TED (Technology, Education and Design) in Los Angeles and announced that he was introducing through Apple’s App Store an app that lets you test your urine. It got quite a bit of attention among the blogs with plenty of jokes about having to pee on your iPhone. More>>

New medical technology draws on nature for inspiration

Sea worms, jellyfish, geckos and spiders may seem unlikely muses to cutting-edge technology. But these creatures are helping stimulate medical innovations — including new adhesives, diagnostic tests and needles — that are slowly migrating from the lab to the clinic. More >>

Ides of March: First-to-File System Expands Available Foreign Prior Art

The first-to-file provisions of the American Invents Act (AIA) take effect on March 16, 2013. Medical device companies have much at stake and are taking precautions now to prepare for this significant change in America’s patent system. Under the first-to-file rules, any patent application filed after March 16, 2013 containing even a single claim with a priority date of March 16, 2013 or later will fall under the first-to-file rules. More >>

Facebook graph search: opportunity or crossing the line for pharma

Facebook’s Graph Search is a search engine that traverses the Facebook data, accessible via a box at the top of Facebook.  The system allows users to make lengthy natural-language queries in search of Facebook-based information about photos, friends, and other content. For example, you could input “Friends of friends who like trail running” and receive a list of people who meet that description—provided their information is public, and they indicated to Facebook that they “Like” trail running. However marketers could also enter “people who have bipolar disorder” and target ads specifically to them. Is this an opportunity for pharma or is it crossing the privacy line ? More >>

FTC Chimes In On Restricted Distribution and Generic Competition; Files Amicus Brief in TRACLEER Case

We thought it would only be a matter of time until the Federal Trade Commission (“FTC”) decided to voice its views in a lawsuit filed last September by Actelion Pharmaceuticals Ltd. and Actelion Clinical Research, Inc. (collectively “Actelion”) in the U.S. District Court for the District of New Jersey seeking declaratory relief that Actelion is under no affirmative duty or obligation to supply prospective ANDA applicants with its brand-name drug products TRACLEER (bosentan) Tablets and ZAVESCA (miglustat) Capsules for purposes of bioequivalence testing and ANDA submission.  That  time has come, and just on the heels of the Counterclaim Plaintiffs’ (Apotex Corp., Roxane Laboratories, Inc., and Actavis Elizabeth LLC) opposition to Actelion’s Motion for Judgment on the Pleadings and to Dismiss Antitrust Counterclaims More >>