One segment of biological products presents a specific opportunity for ag retailers. Several companies have introduced biological technology formulated to blend with a traditional dry bulk fertilizer.

In the third part of our FDA: Drug & Device Team’s series on biological products regulation, we investigate how to qualify for reference product exclusivity (RPE) under the Biologics Price Competition ...

This phrase ‘biologicals’ described as an input for cultivating crops initially confused me. After all, isn’t crop production by its very nature a biological process? Plants basically need water, ...

In the second part of our FDA: Drug & Device Team’s series on biological products regulation, we discuss the regulatory pathways for biological products under Section 351 of the Public Health Service ...

Biologics are complex medications produced through biological processes or from living organisms such as proteins and genes. Biosimilars are what they sound like — similar to, but not the same as, an ...

Regenerative Research Group (rrg.bio) has established itself as one of the premier biologics laboratories in the country through an uncompromising commitment to product quality, safety, and regulatory ...

The Food and Drug Administration (FDA) is launching an effort to streamline the approval process for cheaper alternative “biosimilar” versions of biologic drugs as a way to curb health costs. The ...

The Biologics Price Competition and Innovation Act of (BPCI Act) of 2009 granted responsibility to the FDA for review and approval of a new class of pharmaceuticals referred to as “Biosimilars.” (1) ...

Though biologic medications have improved the treatment landscape by providing the solution to many unmet medical needs, biologics cost much more than small-molecule chemical medications. Biosimilars ...