Several parties from the pharmaceutical industry have teamed up with an advertising association to file a lawsuit against the Department of Health and Human Services (HHS) to prevent a new drug pricing disclosure rule...

On June 6, 2019, the U.S. Department of Health and Human Services' Office of Inspector General issued a report that found that, among a sample U.S. hospitals that obtained non-patient-specific compounded drugs ...

As most folks with any interest in the burgeoning cannabidiol (CBD) industry likely know, on May 31, 2019, the Food and Drug Administration held a public hearing "to obtain scientific data

On May 10, 2019, the Food and Drug Administration issued highly anticipated final guidance that gives drug-makers more clarity on how to demonstrate that a proposed biosimilar product meets the statutory interchangeability standard under the Public Health Service Act

Since our 2018 year-end post on the busy FDA regulatory agenda, we are nearing the halfway mark of the "grace period" the Agency has extended for certain regenerative medicine product developers to

As 2019 quickly approaches, we would like to take a few moments to reflect on the past year of Food and Drug Administration activities and certain big ticket items that made news in 2018.

In his typical forceful style on December 11, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced several big pieces of policy news affecting the nascent biosimilar market.

In the first new guidance document from FDA in several years specific to the subject of direct-to-consumer promotion of prescription drugs and biological products, the Agency is recommending that companies take additional steps ...

As an immediate follow-up to last week's release of the FDA's Biosimilars Action Plan, the Agency is announcing a public hearing for September 4, 2018 to gather stakeholder input on ...

The BAP goes on to address the Agency's obligations to ensure the continued viability of the "virtuous cycle of innovation and competition."

In a highly anticipated step, which had been teased by agency leadership in their public appearances over the past several months, FDA released a series of draft guidance documents pertaining to the development...

A lot has happened since we last addressed new biosimilar developments in January 2018.

Businesses engaged in human drug compounding, both traditional pharmacies and the more recently created outsourcing facilities, have been on quite a rollercoaster ride ...

Joanne Hawana discusses recent actions taken by FDA with regard to regenerative medicine including clarifying what technologies fit within the rubric, the announcement of a wholesale review of polices...

Pharmaceutical industry stakeholders know that drug prices, market competition, supply chain challenges, and shortages of critical drug products have been top of mind for policymakers in recent years.