Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA

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...

Optimal Timing for Expanding Diagnostic Laboratories, South Korea

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...

E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials

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can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written...

Jalux Americas, Inc. (dba J.sweets) Issues Allergy Alert on Undeclared Tree Nuts and Milk in L’espoir Brand Cookies

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,...

ACE2 Receptor Usage across Animal Species by SARS-CoV-2 Variants

by Pill Pals Customer Service | Jul 17, 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. Masato Hatta1, Gloria P. Larson1, Yasuko Hatta1, Wei Wang, Nannan Jiang, Yu-Jin Jung, Li Wang,...

Drug Trials Snapshot: IMAAVY

by Pill Pals Customer Service | Jul 17, 2025 | News

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “MORE INFO” bar...