{"version":"1.0","provider_name":"Brakke Consulting\u306e\u30a6\u30a7\u30d6\u30b5\u30a4\u30c8","provider_url":"https:\/\/brakkeconsulting.com\/ja","title":"News from Brakke Consulting","type":"rich","width":600,"height":338,"html":"<blockquote class=\"wp-embedded-content\" data-secret=\"bWcrWpT9Wz\"><a href=\"https:\/\/brakkeconsulting.com\/ja\/brakke-viewpoint-july-29-2022\/\">\u30d6\u30e9\u30c3\u30b1\u5c55\u671b\u53f0 2022 \u5e74 7 \u6708 29 \u65e5<\/a><\/blockquote><iframe sandbox=\"allow-scripts\" security=\"restricted\" src=\"https:\/\/brakkeconsulting.com\/ja\/brakke-viewpoint-july-29-2022\/embed\/#?secret=bWcrWpT9Wz\" width=\"600\" height=\"338\" title=\"&#8220;Brakke Viewpoint July 29, 2022&#8221; &#8212; Brakke Consulting Website\" data-secret=\"bWcrWpT9Wz\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\" class=\"wp-embedded-content\"><\/iframe><script type=\"text\/javascript\">\n\/* <![CDATA[ *\/\n\/*! This file is auto-generated *\/\n!function(d,l){\"use strict\";l.querySelector&&d.addEventListener&&\"undefined\"!=typeof URL&&(d.wp=d.wp||{},d.wp.receiveEmbedMessage||(d.wp.receiveEmbedMessage=function(e){var t=e.data;if((t||t.secret||t.message||t.value)&&!\/[^a-zA-Z0-9]\/.test(t.secret)){for(var s,r,n,a=l.querySelectorAll('iframe[data-secret=\"'+t.secret+'\"]'),o=l.querySelectorAll('blockquote[data-secret=\"'+t.secret+'\"]'),c=new RegExp(\"^https?:$\",\"i\"),i=0;i<o.length;i++)o[i].style.display=\"none\";for(i=0;i<a.length;i++)s=a[i],e.source===s.contentWindow&&(s.removeAttribute(\"style\"),\"height\"===t.message?(1e3<(r=parseInt(t.value,10))?r=1e3:~~r<200&&(r=200),s.height=r):\"link\"===t.message&&(r=new URL(s.getAttribute(\"src\")),n=new URL(t.value),c.test(n.protocol))&&n.host===r.host&&l.activeElement===s&&(d.top.location.href=t.value))}},d.addEventListener(\"message\",d.wp.receiveEmbedMessage,!1),l.addEventListener(\"DOMContentLoaded\",function(){for(var e,t,s=l.querySelectorAll(\"iframe.wp-embedded-content\"),r=0;r<s.length;r++)(t=(e=s[r]).getAttribute(\"data-secret\"))||(t=Math.random().toString(36).substring(2,12),e.src+=\"#?secret=\"+t,e.setAttribute(\"data-secret\",t)),e.contentWindow.postMessage({message:\"ready\",secret:t},\"*\")},!1)))}(window,document);\n\/\/# sourceURL=https:\/\/brakkeconsulting.com\/wp-includes\/js\/wp-embed.min.js\n\/* ]]> *\/\n<\/script>","description":"Do high FDA Animal Drug Users Fees slow innovation in animal drugs? Each year the FDA ADUFA\/AGDUFA fees change due to inflation, workload, and prior year excesses or shortfalls in collections.\u00a0 Starting in October, New Animal Drug Applications will require a $659,364 check and a supplemental application will need a $329,682 check, 13.5% more than last year.\u00a0 A generic drug ANADA will need a $494,983 check in 2023, down from $548,628 in 2022 due primarily to excess collections in 2021.\u00a0 That\u2019s a lot of money and it must impact innovation. Some interesting information on innovation comes from the workload calculation.\u00a0 The average number of NADAs submitted over the last 5 years (ending May 2022) is 12.8, which is down 22% compared to the 5 years ending September 2018, which had an average of 16.4 applications.\u00a0 The FDA expects 5.25 NADAs in 2023.\u00a0 Comparing these same 5-year periods to each other, supplemental applications are down 22% also, investigational study submissions are down 7%, manufacturing supplements are up 4% and investigational protocol submissions are up 1%.\u00a0 This all leads to an overall 4.5% reduction in workload, which doesn\u2019t reflect well on innovation. However, the workload for Generic Animal Drugs is booming \u2013 it\u2019s up 77%. Over these same two 5-year periods, ANADAs are up 12.5% (27 vs 24), generic investigational study submissionsView Full Post;"}