Commercial Law & Contracts, Administrative Law, Science, Computers & Technology

FDA 510(k) Rescission Authority Upheld - U.S. District Court Finds for FDA in ReGen Litigation

by King & Spalding on 5/22/2013

The United States District Court for the District of Columbia issued an opinion in Ivy Sports Medicine, Inc. v. Sebelius, a lawsuit filed in May 2011 by ReGen Biologics, Inc. (“ReGen”) against the Food and Drug Administration...more

Research-Related Payments and the Physician Payment Sunshine Act: How Reporting Works and What Applicable Manufacturers Should...

by Frederick Ball, Elinor Hart, Michael A. Swit | Duane Morris LLP on 3/6/2013

On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) published long-awaited rules (the "Rules") detailing manufacturers' and group purchasing organizations' reporting requirements under Section 6002 of the...more

Obama Administration Reports on Efforts to Prevent Trade Secret Misappropriation

by Kevin E. Noonan | McDonnell Boehnen Hulbert & Berghoff LLP on 2/26/2013

The Obama Administration issued a Report earlier this month, entitled "Administration Strategy on Mitigating the Theft of U.S. Trade Secrets," that sets forth its efforts to prevent trade secret misappropriation. The Report...more

SBA Rules: Investment Funds Can Now Be Majority Owners of SBIR Companies

by G. Matthew Barnard, Joel Ephross | Duane Morris LLP on 2/22/2013

The Small Business Administration (SBA) recently amended the rules relating to its Small Business Innovation Research (SBIR) program and Small Business Technology Transfer (STTR) program. The new SBA rules implement the...more

EU Proposed Directive on Network and Information Security

by Timothy Nagle, Christine Nielsen, Cynthia O'Donoghue | Reed Smith on 2/14/2013

On 7 February, the European Commission (EC) published an EU Cyber Security Strategy encompassing a proposed Directive on Network and Information Security (NIS Directive). The aim of the Strategy and NIS Directive is to...more

FDA Issues Final Rule Regarding CGMPs for Combination Products

by King & Spalding on 2/4/2013

On Tuesday, January 22, 2013, the United States Food and Drug Administration (FDA or “the Agency”) published a final rule regarding Current Good Manufacturing Practice Requirements for Combination Products. 78 Fed. Reg. 4307...more

Recent Privacy Developments: California AG Continues to Lead on Mobile with New Recommendations and FTC Amends COPPA

by Antony Kim, Stephanie Sharron, Joe Wright | Orrick, Herrington & Sutcliffe LLP on 1/15/2013

Nearly all businesses today are involved in some way in the development or distribution of mobile applications. The first part of this Client Alert highlights recent activities of the California State Attorney General to...more

DOE Grant For Superconducting Wires

by Bruce Goodman | Varnum LLP on 1/14/2013

Lapeer-based Grid Logic has been awarded a $3.8 Million grant from the Department of Energy to develop a low-cost superconducting wire for use by electric utilities. This funding, under the Advanced Research Project Agency...more

California Attorney General Announces Privacy Recommendations for Mobile Apps and the Mobile Industry

by Ieuan Jolly, Brian Nixon, Michael Thurman | Loeb & Loeb LLP on 1/14/2013

Yesterday Kamala Harris, California's Attorney General, issued Privacy on the Go: Recommendations for the Mobile Ecosystem. The report and recommendations are intended to encourage app developers and others in the mobile...more

Privacy in Latin America

by Cynthia J. Rich, Marian Waldmann, Miriam Wugmeister | Morrison & Foerster LLP on 1/14/2013

Originally published in Privacy & Security Law Report on January 7, 2013. The privacy landscape in Latin America is undergoing significant changes. With the enactment or implementation of laws in Colombia, Costa Rica,...more

Chinese Government Decision May Help Brands Protect Themselves

by Stephanie Cohen, Harley Lewin | McCarter & English, LLP on 1/14/2013

Anyone trying to stop Chinese counterfeiters learns almost immediately that most of the information that would ordinarily identify China-based owners of a URL or website is false. That makes it costly or impossible to...more

California’s Attorney General Releases Privacy Recommendations for Mobile Apps

by Karen H Bromberg | Cohen & Gresser LLP on 1/11/2013

California’s Attorney General released, on January 10, 2013, a lengthy set of recommended privacy practices aimed at app developers, app platform providers, mobile ad networks, operating system developers, and mobile...more

Marks of Excellence – the Lakers 33 Game Winning Streak and FCPA Compliance Tools

by Thomas Fox on 1/9/2013

Sorry Bill Simmons, but today we celebrate one of the great modern day records of any American sports franchise. On this day 41 years ago, the Milwaukee Bucks beat the Los Angeles Lakers to end the Lakers 33 game winning...more

FDA Announces Public Meeting to Discuss Standardization and Availability of Medical Device Labeling

by King & Spalding on 1/9/2013

On April 29-30, 2013, FDA will hold a public workshop to discuss standardizing the format and content of medical device labeling and the development of a public repository/database that would provide access to the labeling of...more

FDA Issues Final Guidance Documents on FDA’s eCopy Program for Medical Device Submissions

by King & Spalding on 1/9/2013

On December 31, 2012, FDA issued a final guidance document entitled “eCopy Program for Medical Device Submissions” (“eCopy guidance”). Section 745A(b) of the Federal Food, Drug, and Cosmetic (FDC) Act, which was added by...more

FDA Issues New Guidances Regarding Its Preliminary Review of 510(k) Notices and PMA Applications

by King & Spalding on 1/9/2013

On December 31, 2012, FDA issued two final guidances that replace prior guidances related to the review of premarket submissions: “Refuse to Accept Policies for 510(k)s” and “Acceptance and Filing Reviews for Premarket...more

The New Generation Of Channel Surfing

by Michael Shedletsky | Heenan Blaikie LLP on 1/7/2013

With big media moguls rushing to have their share of the YouTube pie, it is worth examining the fundamental shift in the YouTube platform, prompting Peter Chernin, Time Warner Cable, and RTL Bertlesmann (the largest private...more

New Draft Regulations Soften Impact of CASL, but Concerns about Jobs and Compliance Costs Remain

by Osler, Hoskin & Harcourt LLP on 1/7/2013

Revised draft regulations under Canada’s anti-spam legislation (CASL) have been issued by Industry Canada. While the draft regulations provide some relief to businesses, Industry Canada has elected not to address concerns...more

Data Privacy And Security Risks

by Michael Volkov on 1/7/2013

If there is one issue which causes sleepless nights for business executives, it has to be data privacy and security. While the laws are still being updated and drafted for new technologies and new threats, businesses need to...more

Final SBIR Rules Published

by Jonathan Cain, Alexander Hecht, Abby Matousek | Mintz Levin on 1/5/2013

On December 27, 2012, the US Small Business Administration (SBA) published a final rule to amend regulations governing eligibility for the Small Business Innovation Research (SBIR) and Small Business Technology Transfer...more

FDA Issues Final Guidance on Filing PMAs and 510(k)s

by Seth Mailhot, Peter Reichertz | Sheppard Mullin Richter & Hampton LLP on 1/5/2013

On December 31, 2012, the U.S. Food and Drug Administration (FDA) issued two new guidance documents on the minimum threshold of acceptability for medical device premarket submissions, which are titled “Refuse to Accept Policy...more

Privacy Resolutions for Mobile App Providers in the New Year

by James McPhillips | Pillsbury Global Sourcing Practice on 1/5/2013

The end of 2012 saw a flurry of activity in the area of privacy enforcement. In July, Kamala Harris, the Attorney General of California, announced the formation of California's own state agency to investigate and enforce the...more

Are the Feds Enlisting FedEx to Police the Illegal Pharma Market?

by Jeff Ifrah on 1/4/2013

The government may be coming up with a new cost-effective measure to help balance the federal budget – enlisting private companies to do their policing. A 2011 settlement between the Justice Department and Google for $500...more

Increasing Scrutiny of Consumer Data Collection

by Rochelle Alpert, Karen Butcher, Ron Dreben, W. Reece Hirsch, Dana Nicoletti, Carla Oakley | Morgan Lewis on 1/3/2013

Recent FTC and California Attorney General actions highlight the need to reassess privacy policies. The Federal Trade Commission (FTC) recently ordered the data brokerage industry to provide information on the collection...more

Private Eyes Are Watching You – California Files Its First Internet Consumer Privacy Enforcement Action

by Joan Archer, Jennifer Byrne, Tiffany Schwartz | Armstrong Teasdale LLP on 1/3/2013

Last month, the State of California filed its first enforcement action under its privacy laws against Delta Air Lines, seeking potentially millions of dollars in fines. Under California’s consumer privacy law, all parties...more

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Commercial Law & Contracts › Administrative Law › Science, Computers & Technology

FDA 510(k) Rescission Authority Upheld - U.S. District Court Finds for FDA in ReGen Litigation

Research-Related Payments and the Physician Payment Sunshine Act: How Reporting Works and What Applicable Manufacturers Should...

Obama Administration Reports on Efforts to Prevent Trade Secret Misappropriation

SBA Rules: Investment Funds Can Now Be Majority Owners of SBIR Companies

EU Proposed Directive on Network and Information Security

FDA Issues Final Rule Regarding CGMPs for Combination Products

Recent Privacy Developments: California AG Continues to Lead on Mobile with New Recommendations and FTC Amends COPPA

DOE Grant For Superconducting Wires

California Attorney General Announces Privacy Recommendations for Mobile Apps and the Mobile Industry

Privacy in Latin America

Chinese Government Decision May Help Brands Protect Themselves

California’s Attorney General Releases Privacy Recommendations for Mobile Apps

Marks of Excellence – the Lakers 33 Game Winning Streak and FCPA Compliance Tools

FDA Announces Public Meeting to Discuss Standardization and Availability of Medical Device Labeling

FDA Issues Final Guidance Documents on FDA’s eCopy Program for Medical Device Submissions

FDA Issues New Guidances Regarding Its Preliminary Review of 510(k) Notices and PMA Applications

The New Generation Of Channel Surfing

New Draft Regulations Soften Impact of CASL, but Concerns about Jobs and Compliance Costs Remain

Data Privacy And Security Risks

Final SBIR Rules Published

FDA Issues Final Guidance on Filing PMAs and 510(k)s

Privacy Resolutions for Mobile App Providers in the New Year

Are the Feds Enlisting FedEx to Police the Illegal Pharma Market?

Increasing Scrutiny of Consumer Data Collection

Private Eyes Are Watching You – California Files Its First Internet Consumer Privacy Enforcement Action

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