Search
Home > Posts tagged "U.S. Food and Drug Administration"

Tag: U.S. Food and Drug Administration

FDA Approves First Intratumoral Injection to Treat Non-Metastatic Mast Cell Tumors in Dogs

Mark Bennett
Dogs

Today, the U.S. Food and Drug Administration approved Stelfonta (tigilanol tiglate injection) to treat dogs with non-metastatic, skin-based (cutaneous) mast cell tumors (MCTs). The FDA is also approving Stelfonta to treat non-metastatic MCTs located under the dog’s skin (subcutaneous), in particular areas of a dog’s leg.  Stelfonta is injected directly into the MCT (intratumoral injection). Stelfonta works by activating a…

Read More

FDA Approves Lotion for Nonprescription Use to Treat Head Lice

Rod Washington
head lice

Today, the U.S. Food and Drug Administration approved a lotion to treat head lice for nonprescription, or over-the-counter (OTC), use through a process called a prescription (Rx)-to-OTC switch. The FDA initially approved Sklice (ivermectin) lotion, 0.5% for the treatment of head lice infestation in patients 6 months of age and older as a prescription drug in February 2012. “The Rx-to-OTC…

Read More

FDA Requiring Labeling Changes for Benzodiazepines

Rod Washington
labeling

Boxed Warning to Be Updated to Include Abuse, Addiction and Other Serious Risks The U.S. Food and Drug Administration announced today in a Drug Safety Communication that it is requiring an update to the Boxed Warning, the agency’s most prominent safety warning, and requiring class-wide labeling changes for benzodiazepines to include the risks of abuse, misuse, addiction, physical dependence and…

Read More

FDA Authorizes First Point-of-Care Antibody Test for COVID-19

Rod Washington
Antibody

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first serology (antibody) point-of-care (POC) test for COVID-19. The Assure COVID-19 IgG/IgM Rapid Test Device was first authorized for emergency use by certain labs in July 2020 to help identify individuals with antibodies to SARS-CoV-2, indicating recent or prior COVID-19 infection. Today, that EUA is…

Read More

FDA Announces Major Milestone in New Era of Smarter Food Safety

Rebecca Jo
Food Safety

In a Statement From Deputy Commissioner for Food Policy and Response – Food and Drug Administration Frank Yiannas September 21, 2020: Today, I am excited to announce an important, critical step forward in the U.S. Food and Drug Administration’s efforts to bring about farm-to-table traceability in our food supply. The FDA has proposed a new rule that lays the foundation…

Read More