12/05/2022 Thriftmaster Texas, LLC. d/b/a ThriftMaster Global Holdings, Inc. and TM Global Biosciences, LLC Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated […]

   Subscribe to receive FDA health fraud alerts Health fraud scams refer to products that claim to prevent, treat, or cure diseases or other health conditions, but […]

Ojemda (tovorafenib) Patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 […]

What are the main differences between an FDA inspection of a 503A and 503B compounding facility? What is the difference between a surveillance inspection, a for-cause […]

For Immediate Release: April 23, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]

The Brief Summary The Brief Summary is a quarterly bulletin intended for all OPDP stakeholders. Started in January 2022, The Brief Summary provides news and updates […]

On April 23, 2024, the Food and Drug Administration granted accelerated approval to tovorafenib (Ojemda, Day One Biopharmaceuticals, Inc.) for patients 6 months of age and […]