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May 9, 2022

FDA & American College of Rheumatology (ACR) Virtual Summit – 05/17/2022

On This Page Date: May 17 – 18, 2022 Day1: Tue, May 17 10:00 AM – 4:00 PM ET Day2: Wed, May 18 10:00 AM – […]
May 9, 2022

Benefit-Risk Considerations for Product Quality Assessments

Submit Comments by 07/10/2022 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 […]
May 9, 2022

Pharmcore Inc. dba Hallandale Pharmacy – 605569 – 05/03/2022

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name David G. Rabbani Recipient Title Owner and President Pharmcore Inc. dba Hallandale Pharmacy 2666 SW 36th StFort […]
May 5, 2022

Identification of Medicinal Products (IDMP)

IDMP is a suite of five standards developed within the International Organization for Standardization (ISO) to facilitate the unique identification of medicinal products in the context […]
May 4, 2022

FDA grants regular approval to fam-trastuzumab deruxtecan-nxki for breast cancer

On May 4, 2022, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic HER2-positive breast cancer […]
May 4, 2022

FDA Updates on Paxlovid for Health Care Providers

FDA authorized Paxlovid (nirmatrelvir and ritonavir) in December 2021 for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older […]
May 4, 2022

Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies

Submit Comments by 08/04/2022 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 […]
May 4, 2022

Rationale for FDA’s Position on Cefadroxil

Cefadroxil is FDA-approved for the treatment of: Urinary tract infections caused by E. coli, P. mirabilis, and Klebsiella species. Skin and skin structure infections cause by […]
May 4, 2022

Bea Lydecker’s Naturals, Inc. – 616439 – 02/09/2022

Delivery Method: Overnight Delivery Product: Animal & VeterinaryDrugsFood & Beverages Recipient: Recipient Name Beatrice C. Lydecker-Hayford Recipient Title Owner Bea Lydecker’s Naturals, Inc. 15443 South LaTourette […]
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