Principles for Codevelopment of an In Vitro Companion ... | 合法醫療器材資訊網

2018年9月27日 — Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product Draft Guidance for Industry and Food ... Read More

2018年12月7日 — A companion diagnostic is a medical device, often an in vitro device, which ... a particular therapeutic product's benefits to patients will outweigh any ... ​Principles for Codevelopment of an In Vitro Companion Diagnostic ... Read More

2016年8月18日 — ... Draft Guidance on “Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product held on 8/18/16. Read More

2020年9月13日 — This draft guidance is intended to assist with the codevelopment of a therapeutic product and an accompanying IVD companion diagnostic. Read More

2020年5月29日 — Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product: Draft Guidance for Industry and Food ... Read More

2017年3月2日 — FDA draft guidance on the Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product, published on ... Read More

2016年7月15日 — Principles for Codevelopment of an In Vitro Companion Diagnostic Device With a Therapeutic Product; Draft Guidance for Industry and Food and ... Read More

2016年7月15日 — ... an In Vitro Companion Diagnostic Device With a Therapeutic Product; ... IVD companion diagnostic, a process referred to as codevelopment. Read More