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FDA leaders propose new 'plausible mechanism' pathway for bespoke medicines (raps.org)
6 points by geox 37 days ago | past | 1 comment
FDA draft guidance allows AI/ML devices to evolve without new submissions (raps.org)
1 point by sarusso on April 4, 2023 | past | 2 comments
When to Submit an ANDA vs. a 505(B)(2) Application: FDA Discusses in Draft (raps.org)
2 points by trifit on Nov 5, 2022 | past
MedCon: Industry praises FDA’s digital health Pre-Cert pilot (raps.org)
1 point by moose_ears on May 6, 2022 | past
Covid-19 Vaccine Tracker (raps.org)
2 points by gablusky on May 13, 2020 | past
FDA Proposal to Pull Some Radiological Health Regulations Draws Mixed Reactions (raps.org)
2 points by howard941 on July 17, 2019 | past

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