Newly Added Guidance Documents | 合法醫療器材資訊網

References Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAs (www.fda.gov) Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers Guidance for Industry (www.fda.gov) Data Integrity for In Vivo Bioavailability and Bioequivalence Studies (www.fda.gov) Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies Guidance for Industry (www.fda.gov) Providing Regulatory Submissions in Electronic Format: IND Safety Reports Guidance for Industry (www.fda.gov) Handling and Retention of Bioavailability BA and Bioequivalence BE T...

Search for FDA Guidance Documents | 合法醫療器材資訊網

About FDA Guidance Documents. Guidance documents represent FDA's current thinking on a topic. They do not create or confer any rights for or on any person ... Read More

Guidances (Drugs) | 合法醫療器材資訊網

2021年1月25日 — Guidance documents represent the Agency's current thinking on a particular subject. They do not create or confer any rights for or on any person ... Read More

FDA Guidance Documents | 合法醫療器材資訊網

2021年2月10日 — Guidance documents represent FDA's current thinking on a topic. They do not create or confer any rights for or on any person and do not ... Read More

Guidance Documents (Medical Devices and Radiation ... | 合法醫療器材資訊網

2019年10月11日 — Home page for the CDRH Guidance Document section. Read More

Newly Added Guidance Documents | 合法醫療器材資訊網

Clinical Trials Guidance Documents | 合法醫療器材資訊網

2021年4月27日 — The term 'guidance' includes documents issued as 'FDA ... Read More

COVID-19 | 合法醫療器材資訊網

FDA is providing recommendations, regulatory information, guidance, and technical assistance necessary to support rapid COVID-19 response efforts. Read More

Guidance, Compliance | 合法醫療器材資訊網

2021年5月12日 — Looking for FDA Guidance, Compliance, & Regulatory Information? Web page provides quick links to a variety of topics including ... Read More

Guidance for Industry | 合法醫療器材資訊網

2021年5月4日 — Guidance documents represent FDA's current thinking on a ... Read More

Product | 合法醫療器材資訊網

FDA will strive to issue guidance for a complex product as soon as scientific recommendations are available. In addition to the provided information, sponsors ... Read More

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