by Pill Pals Customer Service | Jul 18, 2025 | News
As described in Section 3033 of the 21st Century Cures Act, a drug is eligible for regenerative medicine advanced therapy (RMAT) designation if: The drug is a regenerative medicine therapy, which is defined as a cell therapy, therapeutic tissue engineering product,...
by Pill Pals Customer Service | Jul 18, 2025 | News
Disclaimer: Early release articles are not considered as final versions. Any changes will be reflected in the online version in the month the article is officially released. Author affiliation: Chonnam National University Hospital, Gwangju, South Korea (U.J. Kim, H.S....
by Pill Pals Customer Service | Jul 18, 2025 | News
Docket Number: FDA-2018-D-1922 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Formal Meetings Between the FDA and...
by Pill Pals Customer Service | Jul 18, 2025 | News
Disclaimer: Early release articles are not considered as final versions. Any changes will be reflected in the online version in the month the article is officially released. Author affiliation: Korea Disease Control and Prevention Agency, Cheongju, South Korea After...
by Pill Pals Customer Service | Jul 18, 2025 | News
Submit Comments by 10/21/2025 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written...
by Pill Pals Customer Service | Jul 17, 2025 | News
Summary Company Announcement Date: July 14, 2025 FDA Publish Date: July 17, 2025 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared milk and tree nuts (almonds and macadamia nuts) Company Name: Jalux Americas,...
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