Product: Drugs Recipient: Recipient Name Livia Tiba Recipient Title Director/CEO Halosense Inc. 48 Knights Bridge RoadLondon ON N6K 3R4Canada halose[email protected] Issuing Office: Center for Drug Evaluation […]

For Immediate Release: June 23, 2023 Today, the U.S. Food and Drug Administration published a new draft guidance to highlight fundamental considerations to researchers investigating the […]

Submit Comments by 08/23/2023 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 […]

Test.  Please ignore. One Two Bold Updated 6/22/2023 10:24 PM Content current as of: 06/22/2023 Regulated Product(s)

Blincyto (blinatumomab) Treatment of CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal […]

Columvi (glofitamab-gxbm) Relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified or large B-cell lymphoma arising from follicular lymphoma, after two or more lines of […]

Drug Sponsor Determination Date Written Request and Related Documents Abacavir/ dolutegravir/ lamivudine ViiV Healthcare Company 6/7/2023 Abatacept BMS 2/14/2017  Acetaminophen Mallinckrodt 7/11/2016 Afatinib  Boehringer Ingelheim Pharmaceuticals, […]

Submit Comments by 09/22/2023 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 […]

[11-24-2020] The Food and Drug Administration is advising consumers not to purchase or use Stree Overlord, a product promoted for sexual enhancement. This product was identified […]