Will FDA Authorize Your Product Health Claims?

Posted by Danielle Stewart on Posted on

According to FDA regulation, conventional food and dietary supplements are allowed to make three categories of claims: health claims, nutrient content claims, and structure/function claims. The FDA tightly regulates the use of these types of claims, with significant penalties for manufacturers who do not comply fully and properly. Nonetheless, many manufacturers, either out of misunderstanding
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Differences between FDA COVID-19 Guidance for Alcohol-Based Hand Sanitizers and Monograph Hand Sanitizers Containing Alcohol

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On June 1, 2020, the FDA released a statement notifying the public that they have taken additional steps to increase the supply of alcohol-based hand sanitizer during the ongoing COVID-19 pandemic. These steps included revising the temporary guidances to clarify manufacturing and compounding certain alcohol-based hand sanitizer products. The revised guidances are listed and linked
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FDA Antimicrobial Drugs Advisory Committee Meeting (AMDAC) Recommends Approval of FETROJA (cefiderocol lyophilized powder)

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On October 16th, 2019, the Antimicrobial Drugs Advisory Committee (AMDAC) reviewed the New Drug Application (NDA) 209445 for cefiderocol lyophilized powder (Shionogi Inc.) for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis due to gram-negative bacteria in patients with limited or no alternative treatment options. FETROJA is a cephalosporin antibacterial drug product consisting
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FDA Approves Selinexor Despite Panel’s Vote To Delay

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On February 26th, 2019, the Oncologic Drugs Advisory Committee assembled to determine the fate of Karyopharm Therapeutics’ latest drug, Selinexor (NDA 212306). Selinexor, an oral XPO1 inhibitor, is formulated to be used in combination with dexamethasone, for the treatment of patients with relapsed refractory multiple myeloma who have received at least three prior therapies and
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FDA Joint Committee Recommends Approval of Uloric (Febuxostat) Tablets

Posted by Danielle Stewart on Posted on

On January 11th, 2019, Takeda Pharmaceuticals appeared before a joint session of the Arthritis Advisory and the Drug Safety and Risk Management Advisory Committees. They were seeking approval for their supplemental new drug application for Uloric tablets (sNDA 021-856). Uloric, a xanthine oxidase inhibitor indicated for the chronic management of hyperuricemia in patients with gout,
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