4/16付で米国FDAから多数の説明資料が公開されています。
ほとんどは、FDAの組織・役割・システムの説明であり、レギュレーションとして直接関係するものはなさそうですが、興味のある方は、下記URLsの資料をご参照ください。
ちなみに、最初の「FDA Public Workshop: CDER and You: Keys to Effective Engagement」は、FDA概要といった感じです。
●「FDA Public Workshop: CDER and You: Keys to Effective Engagement」
https://www.fda.gov/downloads/Drugs/NewsEvents/UCM603834.pdf
●「Collecting Patient Experience Data: How You Can Best Help FDA」
https://www.fda.gov/downloads/Drugs/NewsEvents/UCM604536.pdf
●「Supporting Rare Disease Drug Development: CDER’s Rare Diseases Program」
https://www.fda.gov/downloads/Drugs/NewsEvents/UCM604537.pdf
●「Understanding the Needs of CDER Drug Review Divisions」
https://www.fda.gov/downloads/Drugs/NewsEvents/UCM604538.pdf
●「What CDER Can and Can’t Do」
https://www.fda.gov/downloads/Drugs/NewsEvents/UCM604540.pdf
●「Rocking the Docket」
https://www.fda.gov/downloads/Drugs/NewsEvents/UCM604541.pdf
●「Externally-Led Patient-Focused Drug Development (PFDD) Meetings」
https://www.fda.gov/downloads/Drugs/NewsEvents/UCM604543.pdf
●「FDA Patient Affairs」
https://www.fda.gov/downloads/Drugs/NewsEvents/UCM604544.pdf
●「Office of Health and Constituent Affairs: Patient Representative Program」
https://www.fda.gov/downloads/Drugs/NewsEvents/UCM604545.pdf
●「CBER Patient Engagement」
https://www.fda.gov/downloads/Drugs/NewsEvents/UCM604546.pdf
●「Learn from the Pros - Platelet Disorder Support Association (PDSA)」
https://www.fda.gov/downloads/Drugs/NewsEvents/UCM604547.pdf
●「Learn from the Pros - Depression and Bipolar Support Alliance (DBSA)」
https://www.fda.gov/downloads/Drugs/NewsEvents/UCM604548.pdf
ほとんどは、FDAの組織・役割・システムの説明であり、
ちなみに、最初の「FDA Public Workshop: CDER and You: Keys to Effective Engagement」は、FDA概要といった感じです。
●「FDA Public Workshop: CDER and You: Keys to Effective Engagement」
https://www.fda.gov/downloads/
●「Collecting Patient Experience Data: How You Can Best Help FDA」
https://www.fda.gov/downloads/
●「Supporting Rare Disease Drug Development: CDER’s Rare Diseases Program」
https://www.fda.gov/downloads/
●「Understanding the Needs of CDER Drug Review Divisions」
https://www.fda.gov/downloads/
●「What CDER Can and Can’t Do」
https://www.fda.gov/downloads/
●「Rocking the Docket」
https://www.fda.gov/downloads/
●「Externally-Led Patient-Focused Drug Development (PFDD) Meetings」
https://www.fda.gov/downloads/
●「FDA Patient Affairs」
https://www.fda.gov/downloads/
●「Office of Health and Constituent Affairs: Patient Representative Program」
https://www.fda.gov/downloads/
●「CBER Patient Engagement」
https://www.fda.gov/downloads/
●「Learn from the Pros - Platelet Disorder Support Association (PDSA)」
https://www.fda.gov/downloads/
●「Learn from the Pros - Depression and Bipolar Support Alliance (DBSA)」
https://www.fda.gov/downloads/
執筆者について
経歴 ※このプロフィールは掲載記事執筆時点での内容となります
コメント
/
/
/
コメント