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…tart fruits for which the amount of total sugars per serving is at a level that does not exceed the amount of total sugars in a comparable product with no…
…tabular format. As shown in the tables below, between the period of 1999 and 2012, the CFR grew by a total of 423 pages (10%), although there was a short…
…total revenue amount), and API facilities account for 20% of facility fee revenue (14% of the total revenue amount). Facilities that produce both FDFs and APIs must pay two annual…
…from “State or local nutrition labeling requirements for foods sold in vending machines that are not identical to the [federal] requirements.” However, this voluntary registration does not mean that the…
…2014 user fee rates. All BsUFA user fees – i.e., the initial and annual biosimilar Biological Product Development (“BPD”) fees, the reactivation fee, and the biosimilar biological product application, establishment,…
…generally represent a very modest change vis-à-vis the FY 2015 user fee rates. All BsUFA user fees – i.e., the initial and annual biosimilar Biological Product Development (“BPD”) fees, the…
…nearest thousand dollars), are based on a total number of 1,100 fee-paying full application equivalents expected to be received in FY 2017. Dividing $77,523,000 by the total number of fee-paying…
…Our data showed that between the period of 1999 and 2012, the CFR grew by a total of 423 pages (10%), and that between 1994 and 2011, the FDC Act…
…individual testing recommendations, regarding non-clinical and clinical evaluation of OCT devices, and increased interactive engagement improve the process and reduces overall total time to decision. Requests for participation in the…
…improving the medical device commercialization landscape. Session Details: A Path to Faster Breakthrough Device Commercialization – CDRH’s Total Product Life Cycle Advisory Program (TAP) Thursday, September 19, 2024, 4:30 PM…
…to final approval; and The date and price of acquisition if the drug was not developed by the manufacturer. Additional Manufacturer Reporting Provisions OSHPD will publish the information obtained under…
…of billions of dollars,” as explained in the Plan. Controlling Medicare Part D Patient Out-of-Pocket Costs and Total Drug Costs The Plan supports legislative action to control total drug costs…
…asks for information about several topics, including: General information about sugars that are metabolized differently than traditional sugars. Should the non-traditional sugars be included in total sugars and added sugars…
…same town hall as to what counts as a decision. And some of these are of course new original authorizations…Many of them though are also supplements and amendments to existing…
…1, 2013 and represent a hefty change vis-à-vis the FY 2013 user fee rates. All BsUFA user fees – i.e., the initial and annual biosimilar Biological Product Development (“BPD”) fees,…