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News from the FDA
Content Labeling Requirements Changed for Certain OTC Drug Ingredients
New rules were published on March 24 requiring content labeling (amount present per dosage unit, eg, tablet) and warning labeling for over-the-counter drugs that contain levels of calcium, magnesium, sodium, or potassium that might be harmful to people with certain underlying medical conditions. Mouth rinses, fluoride toothpastes and mouth washes are not covered by this regulation. Under the new rules, the labeling of oral OTC drugs containing sodium, calcium, magnesium or potassium must state the amount of a particular ingredient in each dose if they contain: 1) 5 mg or more of sodium in a single dose; 2) 20 mg or more of calcium in a single dose; 3) 8 mg or more of magnesium in a single dose; or 4) 5 mg or more of potassium in a single dose. The new rules also require new warnings on the label to alert people with kidney stones, decreased kidney function due to kidney disease, or people who are on sodium-, calcium-, magnesium-, or potassium-restricted diets to consult their doctors before using products for oral ingestion that contain more than: 1) 140 mg of sodium as the maximum daily dose; 2) 3.2 grams of calcium as the maximum daily dose; 3) 600 mg of magnesium as the maximum daily dose; or 4) 975 mg potassium as the maximum daily dose. The effective date of these rules was April 23.
The DOJ's Corporate Enforcement Policy: One Year Later
The DOJ's Criminal Division issued three declinations since the issuance of the revised CEP a year ago. Review of these cases gives insight into DOJ's implementation of the new policy in practice.
Use of Deferred Prosecution Agreements In White Collar Investigations
This article discusses the practical and policy reasons for the use of DPAs and NPAs in white-collar criminal investigations, and considers the NDAA's new reporting provision and its relationship with other efforts to enhance transparency in DOJ decision-making.
The DOJ's New Parameters for Evaluating Corporate Compliance Programs
The parameters set forth in the DOJ's memorandum have implications not only for the government's evaluation of compliance programs in the context of criminal charging decisions, but also for how defense counsel structure their conference-room advocacy seeking declinations or lesser sanctions in both criminal and civil investigations.
CLE Shouldn't Be the Only Mandatory Training for Attorneys
Each stage of an attorney's career offers opportunities for a curriculum that addresses both the individual's and the firm's need to drive success.
Discovery of Claim Construction and Infringement Analysis May be Compelled Prior to a Markman Hearing
A defendant in a patent infringement suit may, during discovery and prior to a <i>Markman</i> hearing, compel the plaintiff to produce claim charts, claim constructions, and element-by-element infringement analyses.