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…about that in a moment). Cargill can also continue to describe erythritol as a “natural sweetener” on labels, but instead of stating that it is produced by a “natural process,”…
…issues detailed above, but takes care to allow agencies to avoid disclosure of privileged or other information where there is a legal basis for withholding the information. The ACUS also…
…to include their product, Glucagel. The petition describes Glucagel as a “barley beta-glucan fiber that provides a high purity (75%) form [that] lends itself to inclusion in a wide array…
…company settled in 2011. The Kellogg experience is not unusual. FTC investigations and settlements are often followed by class action suits, and state attorney general inquiries can result in federal…
…notified Dr. Coleman that “exceptional circumstances” warranted an extension. The DEA did not provide a notice of exceptional circumstances and did not respond at all until “one year, four months,…
…A topic of “overall testing strategy” may be a helpful addition to the template to allow these broader, initial discussions. The template allows up to ten (10) questions and will…
The ability to successfully obtain FDA approval is critical to the success of a medical device. However, sometimes even the most dedicated efforts fall flat when FDA says “No.” What…
…March 20 has been cancelled. The March 20 Joint Meeting concerned the NDA for naloxone hydrochloride nasal spray for nonprescription use as an opioid reversal agent in the emergency treatment…