Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Reference #: 25-HFD-45-04-01 Product: Drugs Recipient: Nana Barseghian, M.D. 19875 Nordhoff StreetNorthridge, CA 91324United States Issuing Office: […]

The Food and Drug Administration is advising consumers not to purchase or use Umovy, a product promoted and sold for joint pain on various websites, including […]

The Food and Drug Administration is advising consumers not to purchase or use Unavy, a product promoted and sold for joint pain on various websites, including […]

Exceptions or additions to the recognized standards For the bacteria listed below, susceptibility test interpretive criteria are not recognized at this time: Anaerobes Content current as […]

FDA has reevaluated data supporting amoxicillin/clavulanate breakpoints against Haemophilus influenzae. The review included a publication describing the Clinical and Laboratory Standards Institute (CLSI) rationale for revision […]

The Food and Drug Administration is advising consumers not to purchase or use dolotrex, a product promoted and sold for joint pain on various websites, including, […]

eCTD Technical Conformance Guide Documentation and Resources 1.9 Final Guidance for Industry: Providing Regulatory Submissions in Electronic Format – eCTD Specifications 09/09/2024     eCTD Backbone […]

On May 14, 2025, the Food and Drug Administration granted accelerated approval to telisotuzumab vedotin-tllv (Emrelis, AbbVie Inc.), a c-Met-directed antibody and microtubule inhibitor conjugate, for […]

On May 14, 2025, the Food and Drug Administration approved belzutifan (Welireg, Merck & Co., Inc.) for adult and pediatric patients 12 years and older with […]