Welcome to Alston & Bird’s introduction to biological products regulation. In this five-part intro-level series, we provide answers to a number ...

The Nobel Prize in Medicine will never be awarded for excellence in the formulation and manufacture of biologic medicines. That’s understandable. Patients who need these medicines deserve the product ...

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 ...

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.

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 ...

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 ...

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 ...

Biologic drugs account for a disproportionate share of the increase in pharmaceutical spending in the US and worldwide. Against this backdrop, many look to the expanding market for ...

The spine biologics market is set for growth due to an aging population with increasing spinal conditions and a shift towards minimally invasive surgeries. Opportunities arise from advanced synthetic ...

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, ...