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 ...

The U.S. Food and Drug Administration today announced another major step in its initiative to streamline the development of biosimilar medicines, ...

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.

Pam Marrone, co-founder of Invasive Species Corporation, and previous founder of two additional biological businesses, shared her key takeaways with certified crop advisers during a recent webinar ...

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 ...

Biosimilars are manufactured by different companies but have potency, safety, and efficacy very similar to previously approved reference biologics. Creation of a regulatory pathway for biosimilars was ...

Please provide your email address to receive an email when new articles are posted on . NASHVILLE, Tenn. — A presenter, here, suggested ways that orthopedic surgeons can avoid being scrutinized by the ...

The FDA released Feb. 24 the first version of the Purple Book, a new online database of biological product information. The Purple Book is modeled after the Orange Book, a list of every prescription ...

Mirroring legislation facilitating the introduction of generic drugs to compete with branded small-molecule drugs, policymakers created a path for approval of “biosimilars” to reduce prices by ...

Once the active ingredient is defined, an Applicant must select which patent, or patents, to put forward for extension. The statute permits only one PTE per regulatory review period, so the choice is ...