User:Jpuvogel/sandbox

Microalgae is commonly fed to fish in hatcheries. Microalgae is high in proteins and carbohydrates. Two microalgae species, I. galbana and C. calcitrans are mostly composed of proteins. Clinical settings that have participated in the REMS program have asked the FDA to make the FDA’s reviews of their practices public so that they can more easily view them and adjust to feedback. The FDA planned to create a “Summary of the REMS Assessment” document that would publicize their assessment of clinical settings in the REMS program. The FDA made a public request for comment on the idea of publishing the Summary of the REMS Assessment. Parties in the REMS program have to request the Summr through the Freedom of Information Act.

The Health and Human Services Office of the Inspector General (OIG) reported that manufacturers of extended release, long acting (ER/LA) opioids were not meeting their assigned REMS goals. Between 2014 and 2017, the FDA stated they did not have enough data to determine whether the REMS program was sufficiently preventing opioid abuse. The OIG recommended that parties in the REMS program provide the FDA more data. The FDA would be late in evaluating that data, leaving those parties with little time to adjust to the review before their next examination. The OIG encouraged the FDA to implement training for those who prescribe opioids. In 2020, clinical settings enrolled in the REMS program asked the FDA to make their reviews of REMS compliance public so that they can more easily view the records and adjust to feedback. Between 2014 and 2017, the FDA stated they did not have enough data to determine whether the REMS program was sufficiently preventing opioid abuse. The Health and Human Services Office of the Inspector General recommended that parties in the REMS program provide the FDA more data. The FDA was habitually late in evaluating that data, reportedly leaving those parties with inadequate time to react to the review before their next assessment. In November 2020, the FDA planned to create a “Summary of the REMS Assessment” document that would publicize their assessments of clinical settings and manufacturers in the REMS program. The FDA made a public request for comment on the idea of publishing the Summary of the REMS Assessment. Without the publication for the Summary, parties in the REMS program must request it using the Freedom of Information Act.