T’was the Friday before Christmas and all through the House – and Senate… Perhaps an out of context fairytale is not how you expect me to start a discussion about the Food Safety Modernization Act (FSMA), or “Fizz Ma” to some.
Standing in the door of my school cafeteria was a nun, who in the full garb of the Sisters of the Blessed Sacrament stood at about 7 feet tall.
Tampa Bay Police report, shortly after dinner, Ronnie Morales felt sick and called 911. However, he was feeling so ill that his girlfriend drove him to St. Joseph’s Hospital.
FDA Finalizes Guidance On Drug Chemistry, Manufacturing, and Controls Postapproval Changes, Allows More to Be Submitted in Annual Reports
Over the years, the number of chemistry, manufacturing, and controls (CMC) postapproval drug manufacturing supplements for NDAs and ANDAs submitted to FDA has continued to increase.
The FDA announced yesterday that it is revisiting a draft guidance issued in 2009 that generated a significant amount of class action litigation over the last year.
Recently, the Delaware Supreme Court decided Tumlinson v. Advanced Micro Devices, Inc., No. 672, 2012 (Del. Nov. 21, 2013). This case provides a great example of the so-called “gatekeeper” function of the court when it comes to the admission of expert testimony in civil cases.
Dairy farmers, and other food animal producers, should be ever-vigilant in their use of medications to treat their herds and flocks, otherwise they may be at risk of violating certain federal laws.
The U.S. Department of Health and Human Services, Food and Drug Administration (FDA) recently issued draft guidance entitled “Guidance for Industry-Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media For Prescription Human and Animal Drugs and Biologics.”
With each passing poultry-associated Salmonella outbreak over the past few years, there has been an increased focus on this pathogen and its control. Along with that is an increasing use of the term “virulent.”