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1. www.fda.gov › medical-devices › cdrh-international-affairsU.S.-Japan Regulatory Collaboration | FDA

   www.fda.gov › medical-devices › cdrh-international-affairs

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   2023年7月13日 · Through HBD-led projects, U.S. and Japanese regulators (including the FDA), academia, and industry collaborate regularly to promote regulatory convergence and address barriers that may delay ...

2. www.fda.gov › consumers › consumer-updates5 Tips for Traveling to the U.S. With Medications | FDA

   www.fda.gov › consumers › consumer-updates

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   A rule of thumb: Bring no more than a 90-day supply of medication. If you’re staying longer than 90 days, you may have additional medication sent to you by mail or courier. Include documentation ...

3. www.fda.gov › drugs › development-approval-process-drugsDrug Approvals and Databases | FDA

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

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   New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products. This Week's Drug Approvals. CDER highlights key Web sites. Web page provides quick links to everything ...

4. www.fda.gov › food › registration-food-facilities-and-otherOnline Registration of Food Facilities | FDA

   www.fda.gov › food › registration-food-facilities-and-other

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   As part of the provisions of the Bioterrorism Act of 2002, food facilities are required to register with FDA. This page contains links with information on how to register a food facility.

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

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

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   Releasable establishment registration and listing information under the Freedom of Information Act is available by searching the Establishment Registration and Listing database. The database is ...

6. www.fda.gov › drugs › resources-information-approved-drugsFDA grants accelerated approval to adagrasib for KRAS ...

   www.fda.gov › drugs › resources-information-approved-drugs

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   2022年12月12日 · On December 12, 2022, the Food and Drug Administration (FDA) granted accelerated approval to adagrasib (Krazati, Mirati Therapeutics, Inc.), a RAS GTPase family inhibitor, for adult patients with...

7. www.fda.gov › drugs › fda-approves-first-drug-decrease-urineFDA approves first drug to decrease urine protein in IgA ...

   www.fda.gov › drugs › fda-approves-first-drug-decrease-urine

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   2021年12月17日 · Orphan drug designation provides incentives to assist and encourage drug development for rare diseases. FDA has granted accelerated approval for Tarpeyo (budesonide) delayed release capsules to ...