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been teased by agency leadership in their public appearances over the past several months, FDA released a series of draft guidance documents pertaining to the development...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

It has been a few months since we reported on Federal Court wranglings with the Biologics Price Competition and Innovation Act, or BPCIA, which created the nation's abbreviated marketing pathway for biosimilar products

Happy New Year! And now on to your regular Consumer Product Matters programming…

Yesterday we started off our year-end series of blog posts with the first part of a review of FDA's actions for 2017 in the therapeutic products space.

As is the tradition here at Health Law & Policy Matters, towards the end of the year we take stock of what transpired in our respective industries and highlight important legal, regulatory...

As we predicted earlier this year, Congress is making moves toward enacting cosmetics reform legislation in the near future.