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December 2020 The purpose of this guidance is to advise food manufacturers of our intent to exercise enforcement discretion for declaration of the name “potassium salt” in the ingredient statement on food labels as an alternative to the common or usual name “potassium chloride.” FDA intends to exercise this enforcement discretion to provide industry with greater flexibility when labeling their food products, including those that are formulated to reduce sodium content. This enforcement discretion may result in manufacturers using potassium chloride as a substitute ingredient for some...

Center for Drug Evaluation and Research This guidance provides information regarding the process by which generic drug manufacturers and related industry or their representatives can submit to FDA controlled correspondence requesting information related to generic drug development. This guidance also describes the Agency’s process for providing communications related to such correspondence. This guidance replaces the September 2015 guidance for industry Controlled Correspondence Related to Generic Drug Development. The September 2015 guidance was issued as part of FDA’s implementation of ...

Center for Devices and Radiological Health This guidance provides performance criteria for magnetic resonance (MR) receive-only coils in support of the Safety and Performance Based Pathway. Under this framework, submitters (you) planning to submit a 510(k) using the Safety and Performance Based Pathway for MR receive-only coils will have the option to use the performance criteria proposed in this guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device. Submit Comments

Adjoining courthouse. a few days earlier, sobel was here for a bail hearing with his co-defendant and girlfriend ariel potter. he attempted to get an envelope to her by pretending she dropped it, and then handing it to a deputy to give to her. >> i'm going to try to give it to one of the deputies down there saying she forget it in the courtroom and hopefully it gets into her hands. >> but not only did the deputy apparently leave it behind, it's just been discovered by another. >> i think this is a female's property item. it's a paper bag. she wrote down her name, her location, report number, t...

20 miles away at sacramento county's downtown jail inmates make their way to and from the adjoining courthouse. a few days earlier, sobel was here for a bail hearing with his co-defendant and girlfriend, ariel potter. he attempted to get an envelope to her by pretending she dropped it and handing it to a deputy to give to her. >> i'm going to try to give it to one of the deputies down there, saying she forgot it in the courtroom and hopefully it gets into her hands. >> but not only did the deputy apparently leave it behind, it's just been discovered by another. >> i think it's a female's prope...