雅虎香港 搜尋

搜尋結果

1. www.fda.gov › regulatory-information › search-fda-guidanceDetermining Whether to Submit an ANDA or a 505(b)(2) ...

   www.fda.gov › regulatory-information › search-fda-guidance

   • 網頁紀錄

   This guidance is intended to serve as a foundational guidance to assist applicants in determining which one of the abbreviated approval pathways under the Federal Food, Drug, and Cosmetic Act (FD&C...

2. www.fda.gov › drugs › development-approval-process-drugsDrug Approvals and Databases | FDA - U.S. Food and Drug ...

   www.fda.gov › drugs › development-approval-process-drugs

   • 網頁紀錄

   Web page provides quick links to everything from acronyms to wholesale distributor and third-party logistics providers reporting. Additional topics include: approved REMS, drug shortages, and the...

3. www.fda.gov › drugs › development-approval-process-drugsLaws, Regulations, Policies and Procedures for Drug ...

   www.fda.gov › drugs › development-approval-process-drugs

   • 網頁紀錄

   Laws, Regulations, Policies and Procedures for Drug Applications. The mission of FDA is to enforce laws enacted by the U.S. Congress and regulations established by the Agency to protect the ...

4. www.fda.govU.S. Food and Drug Administration

   www.fda.gov

   • 網頁紀錄

   2024年7月22日 · The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and ...

5. www.fda.gov › medical-devices › device-registration-andSearch Registration and Listing | FDA

   www.fda.gov › medical-devices › device-registration-and

   • 網頁紀錄

   Search the Registration & Listing database. Establishment Registration and Medical Device Listing Files for Download. Releasable establishment registration and listing information under the ...

6. www.fda.gov › regulatory-information › search-fda-guidanceAnalytical Procedures and Methods Validation for Drugs and ...

   www.fda.gov › regulatory-information › search-fda-guidance

   • 網頁紀錄

   2020年4月21日 · Analytical Procedures and Methods Validation for Drugs and Biologics. Download the Final Guidance Document Read the Federal Register Notice. Final. Share. Linkedin. Docket Number: FDA-2015-N-0007 ...

7. www.fda.gov › media › 156350Overview of the 505 (B)(2) Regulatory Pathway for New Drug ...

   www.fda.gov › media › 156350

   Section 505(b)(1) NDA. “Stand-alone” NDA. Submitted under section 505(b)(1) and approved under section 505(c) Contains full reports of investigations of safety and effectiveness that were ...