{"id":649,"date":"2020-06-01T17:40:38","date_gmt":"2020-06-01T21:40:38","guid":{"rendered":"http:\/\/blogs.duanemorris.com\/coronaviruscovid19\/?p=649"},"modified":"2020-08-31T11:00:40","modified_gmt":"2020-08-31T15:00:40","slug":"fda-provides-two-new-guidances-for-investigational-new-drug-applications-and-clinical-trial-expectations-for-drugs-and-biological-products-proposed-for-use-against-covid-19","status":"publish","type":"post","link":"https:\/\/blogs.duanemorris.com\/coronaviruscovid19\/2020\/06\/01\/fda-provides-two-new-guidances-for-investigational-new-drug-applications-and-clinical-trial-expectations-for-drugs-and-biological-products-proposed-for-use-against-covid-19\/","title":{"rendered":"FDA Provides Two New Guidances for Investigational New Drug Applications and Clinical Trial Expectations for Drugs and Biological Products Proposed for Use Against COVID-19"},"content":{"rendered":"<p>On May 11, 2020, the FDA issued two new guidances for industry and investigators of drugs and biological products proposed for use against COVID-19. These two guidances, \u201cCOVID-19 Public Health Emergency: General Considerations for Pre-IND Meetings Requests for COVID-19 Related Drugs and Biological Products\u201d and \u201cCOVID-19: Developing Drugs and Biological Products for Treatment of Prevention,\u201d provide insight into the expectations of the FDA regarding new treatment drug development programs in the fight against COVID-19.<\/p>\n<p>To read the full text of this Duane Morris <em>Alert<\/em>, please <a href=\"https:\/\/www.duanemorris.com\/alerts\/fda_provides_two_new_guidances_investigational_new_drug_applications_clinical_trial_0620.html\" target=\"_blank\" rel=\"noopener noreferrer\">visit the firm website<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>On May 11, 2020, the FDA issued two new guidances for industry and investigators of drugs and biological products proposed for use against COVID-19. These two guidances, \u201cCOVID-19 Public Health Emergency: General Considerations for Pre-IND Meetings Requests for COVID-19 Related Drugs and Biological Products\u201d and \u201cCOVID-19: Developing Drugs and Biological Products for Treatment of Prevention,\u201d &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/blogs.duanemorris.com\/coronaviruscovid19\/2020\/06\/01\/fda-provides-two-new-guidances-for-investigational-new-drug-applications-and-clinical-trial-expectations-for-drugs-and-biological-products-proposed-for-use-against-covid-19\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;FDA Provides Two New Guidances for Investigational New Drug Applications and Clinical Trial Expectations for Drugs and Biological Products Proposed for Use Against COVID-19&#8221;<\/span><\/a><\/p>\n","protected":false},"author":6,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2],"tags":[846,413,86,46,273,957,461,630],"ppma_author":[1043],"class_list":["post-649","post","type-post","status-publish","format-standard","hentry","category-general","tag-biological-products","tag-covid-19-treatment","tag-drugs","tag-fda","tag-guidance","tag-life-sciences-and-medical-technologies","tag-treatment","tag-u-s-food-drug-administration"],"authors":[{"term_id":1043,"user_id":6,"is_guest":0,"slug":"duanemorris3","display_name":"Duane Morris","avatar_url":"https:\/\/secure.gravatar.com\/avatar\/843ff6e7a8fe5fc92109b47a45f34b6cf0ea499e6e788db23456c838b0ae6747?s=96&d=blank&r=g","0":null,"1":"","2":"","3":"","4":"","5":"","6":"","7":"","8":""}],"_links":{"self":[{"href":"https:\/\/blogs.duanemorris.com\/coronaviruscovid19\/wp-json\/wp\/v2\/posts\/649","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.duanemorris.com\/coronaviruscovid19\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.duanemorris.com\/coronaviruscovid19\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/coronaviruscovid19\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/coronaviruscovid19\/wp-json\/wp\/v2\/comments?post=649"}],"version-history":[{"count":0,"href":"https:\/\/blogs.duanemorris.com\/coronaviruscovid19\/wp-json\/wp\/v2\/posts\/649\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.duanemorris.com\/coronaviruscovid19\/wp-json\/wp\/v2\/media?parent=649"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/coronaviruscovid19\/wp-json\/wp\/v2\/categories?post=649"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/coronaviruscovid19\/wp-json\/wp\/v2\/tags?post=649"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/coronaviruscovid19\/wp-json\/wp\/v2\/ppma_author?post=649"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}