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FDA Holds Public Hearing On Proposed Label Change Rule

On March 27, 2015, the FDA held a public meeting regarding its proposed generic drug labeling rule, a rule that would allow ANDA holders to unilaterally update labeling prior to FDA approval. Testimony from proponents of the...more

OCR’s Enforcement of HIPAA’s Privacy and Security Rules Continues with Robust 2014

With the news of the recent cyber-attack and resulting data breach at health insurance giant Anthem Inc., the buzz around data security and privacy is again high. The Anthem breach serves as a reminder to those entities...more

FDA Issues Revised Draft Guidance on Disclosures of Risk Information in Consumer-Friendly Print Advertisements and Promotional...

The U.S. Food and Drug Administration (FDA) recently released its Revised Draft Guidance entitled “Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and...more

Update on State Attorneys General: Connecticut Creates a Permanent Privacy Department; NAAG Covers Big Data, Cybersecurity, and...

The federal government may be pushing a cybersecurity and data privacy agenda, but that doesn’t mean that the states are taking a back seat. The state attorneys general are maintaining their focus on issues relating to...more

EPA and FDA Sign Memorandum of Understanding to Share Data

The U.S. Environmental Protection Agency (EPA) and the U.S. Food and Drug Administration (FDA) have executed a Memorandum of Understanding (MOU) on Information Sharing regarding the sharing of data and other confidential...more

FDA Issues New Rules for Testing of Reusable Medical Devices

The U.S. Food and Drug Administration (FDA) recently announced its tougher new requirements for testing reusable medical devices. ...more

Guest Blog Post: Changes to the Polish Data Protection Act

On 1st January 2015 amendments to the Polish Data Protection Act of 29th August 1997 came into force. These amendments (the “Amendments”) impact: (i) the role played by the “administrator bezpieczenstwa informacji,” (“DPO”)...more

The 'Palmetto Put-Down' Endangers Drug Cos. Nationwide

On Feb. 25, 2015, nearly two years after argument, the South Carolina Supreme Court directed entry of a $136 million judgment against Janssen Pharmaceuticals Inc. These civil penalties stemmed from a suit brought by the...more

Wyndham Challenges Authority Of FTC To Regulate Cybersecurity

On March 3, 2015, a judicial panel from the U.S. Court of Appeals for the Third Circuit heard oral arguments in a challenge brought by Wyndham Worldwide Corp. (“Wyndham”) against the Federal Trade Commission’s (“FTC”)...more

FDA Regulatory and Compliance Monthly Recap - February 2015

FY 2016 budget request reflects FDA’s broadening scope of activities - The regulator’s requested budget of $4.9 billion for the upcoming fiscal year represents a 9% increase from the enacted FY 2015 budget, with $147.7...more

Safety Labeling: Public Meeting Later This Month and Comment Period Extended – Key Dates Coming Up

On March 27, 2015, FDA plans to hold a public meeting entitled, “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products”. The meeting was announced in a Federal Register Notice posted...more

Why the FTC Can Go After Companies For Insufficient Data Security Allegations

The FTC seems more confident than ever in its authority to go after companies with insufficient data security measures. As of January 2015, it had settled 53 data-security enforcement actions, and FTC Senior Attorney Lesley...more

Another Good Reason to Pay Heed to Cyber Security

For many companies, the prospect of a dreadful, costly and reputation-damaging cyber-attack and data breach is all the motivation they need to assess and improve their cyber security and data protection posture RIGHT NOW. ...more

Third Circuit Hears Oral Argument Over Whether FTC Has Authority To Regulate Data Security

After much anticipation, the Third Circuit heard oral arguments (audio) last Tuesday in the interlocutory appeal in FTC v. Wyndham Worldwide Corp. We have written previously about this case, which likely will be a significant...more

FCA publishes Memorandum of Understanding between the FCA and ICO

On 28 January 2015, the Financial Conduct Authority (FCA) published the Memorandum of Understanding (MoU) which it entered into with the Information Commissioner’s Office (ICO) (dated 29 September 2014)....more

Food Safety & Nutrition

The regulatory and legislative outlook for Food Safety and Nutrition is, compared to other more contentious and politicized issues, fairly robust for the next two years. At the federal agencies, there will be continued...more

How Data Privacy Regulations Changed Across Asia-Pacific in 2014

2014 saw a large number of significant developments in data privacy laws across Asia-Pacific. However, unsurprisingly there has not been a consistent approach across Asia-Pacific towards the development of data privacy...more

FDA Attempts to Clarify Enforcement Position Regarding Evolving Health Technology

Recently, the U.S. Food and Drug Administration (FDA) has issued a flurry of guidance and draft guidance in an effort to better define the types of products that the FDA will choose to actively regulate. In one of these...more

New Cyber Agency to Combat Cyber Threats

The Obama administration, on February 10, announced its intention to create a new federal agency to combat cyber threats and coordinate digital intelligence among all federal agencies....more

Executive order "promoting private sector cybersecurity information sharing": top points

In conjunction with the recent White House Summit on Cybersecurity and Consumer Protection Summit, President Barack Obama has issued a much-anticipated cybersecurity information sharing Executive Order, "Promoting Private...more

UK Information Commissioner’s Office (ICO) Receives Power to Audit National Health Service

The ICO has welcomed a change in legislation which came into effect on 1 February 2015 enabling it to audit National Health Service (NHS) bodies to check for compliance with the UK Data Protection Act 1998. ...more

23andMe Receives FDA Approval for Genetic Diagnostic Test

Last Thursday the genetic diagnostic and DNA analysis company 23andMe announced that the FDA had granted the company approval to market a genetic diagnostic test for Bloom's Syndrome, the first such approval for this rare...more

Data Protection – Cookie sweeps and enforcement actions – Time for a common approach

There have been a lot of discussions about the results of the latest Cookie Sweep carried out in 8 EU member states (for more information see also the latest post of our Patrick van Eecke and Julie De Bruyn, and the Cookie...more

White House Unveils New Federal Cybersecurity Agency

On February 10, the White House announced it will establish the Cyber Threat Intelligence Integration Center (CTIIC). In prepared remarks, Lisa Monaco, Assistant to the President for Homeland Security and Counterrorism,...more

FDA Proposed Rule in Flux?

On Tuesday, the U.S. Food and Drug Administration (FDA) announced that it has reopened the comment period for its proposed rule on generic drug labeling. It has also scheduled a day-long public meeting to hear comments and...more

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