Drug Approvals and Databases | 合法醫療器材資訊網

Read More

2018年3月29日 — Approval information by product type. ... or diagnosing disease (such as thermometers, artificial hearts, and home pregnancy test kits). Read More

2021年2月1日 — Animal Drugs @ FDA is an online database of FDA-approved animal drugs. ... Disclosure of the compliance status of firms helps to provide the ... Read More

2020年6月18日 — Additional topics include: approved REMS, drug shortages, and the Orange ... Inactive Ingredient Search for Approved Drug Products Search Read More

2017年12月23日 — Releasable establishment registration and listing information under the Freedom of Information Act is available by searching the Establishment ... Read More

2018年3月26日 — Search the PMA Database. Regulation also provides for the submission of a humanitarian device exemption (HDE) application. Read More

Drugs@FDA: FDA-Approved Drugs · Search by Drug Name, Active Ingredient, or Application Number* · Browse by Drug Name. Read More

Read More

For comprehensive approval reports, please use the monthly All Approvals report on Drugs@FDA. 7 Day Report; 14 Day Report. July 14, 2021. Drug Name and Read More

... that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval. Read More