Zhong Li’s extensive history with the FDA offers crucial lessons on how companies in the pharmaceutical and biopharmaceutical sectors should approach inspection preparedness.  As an experienced FDA ...

FDA inspections are essential to ensuring the safety and quality of products in the food, pharmaceutical, and medical device industries. One of the experienced professionals in this field is John ...

The FDA has said it plans to conduct more unannounced inspections at foreign facilities that produce food and medical products intended for Americans.

FDA announced a three-part agenda “to increase transparency and ensure the safety of chemicals in our food.” This step ...

The CVR lost around three quarters of its value after BMS revealed on its third-quarter results call that the FDA still hasn’t carried out an inspection of a manufacturing facility that will be ...

There are uncertainties regarding the FDA inspection readiness and capacity ... CEO Q: What is the timeline and process for the NDA filing following the SHIELD 2 trial data? A: The NDA submission ...

It’s been more than three years since DBV Technologies’ peanuty allergy therapy was rejected for FDA approval ... held back by a complicated billing process that held back access, as well ...

An FDA-approved biosimilar is a biological product that is highly similar to and has no clinically meaningful differences in terms of safety or effectiveness from an existing FDA-licensed ...

leveraging a dual path strategy where we commercialize our proprietary formulations via 503B compounding while continuing to seek FDA approval as well as taking steps toward launching certain ...

According to the Arizona Department of Transportation, part of the Loop 101 Agua Fria and I-10 will be closed for various construction projects. A Surprise man is accused of killing his wife with ...