Tracy A Finken

February 12, 2016 | The Legal Intelligencer

The Individuals with Disabilities Education Act (IDEA) is a federal law that ensures special education to eligible children with disabilities. The IDEA governs how states address the educational needs of children with disabilities. Pursuant to the IDEA, each child with a disability must be provided with a free appropriate public education (FAPE) that prepares them for further education, employment and independent living. A FAPE is the standard of education that is guaranteed by the IDEA to be provided to all children between the ages of 3 and 21. FAPE requires that each eligible child receive a program of special education and related services individually designed to meet his or her unique needs, from which that child must obtain meaningful educational benefit. FAPE must be provided in conformity with an ­individualized ­education plan.

By Tracy A. Finken

4 minute read

April 10, 2015 | The Legal Intelligencer

On March 27, the U.S. Food and Drug Administration held a public meeting regarding its proposed generic-drug labeling rule. The rule proposed by the FDA in November 2013, titled "Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products," would allow a generic manufacturer to use the CBE-0 process to implement a safety-related labeling change for its drug unilaterally, prior to the FDA approving the label change.

By Tracy A. Finken

4 minute read

April 10, 2015 | The Legal Intelligencer

On March 27, the U.S. Food and Drug Administration held a public meeting regarding its proposed generic-drug labeling rule. The rule proposed by the FDA in November 2013, titled "Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products," would allow a generic manufacturer to use the CBE-0 process to implement a safety-related labeling change for its drug unilaterally, prior to the FDA approving the label change.

By Tracy A. Finken

4 minute read

September 13, 2013 | The Legal Intelligencer

In this day and age, most law firms have a website and use the Internet as a large part of their overall marketing scheme. However, the ethical considerations are plentiful and not always clear-cut.

By Tracy A. Finken

6 minute read