Moving forward with the approval pathway for biosimilars: FDA provides draft guidance on meetings with product sponsors *

USA - April 10 2013
April 1, 2013, the Food and Drug Administration (FDA) announced the availability of a new draft guidance addressing the procedures for requesting and…

Co-authors: John R. Manthei, Eitan N. Bernstein.

---

POM Wonderful opinion provides limited clarification on FTC substantiation requirements *

USA - October 1 2012
The food and dietary supplement industries have struggled to interpret and implement the Federal Trade Commission’s (FTC’s) unsettled standard on health claim substantiation.

Co-authors: Patrick C. English, Rebecca N. Brandt.

---

FDA offers new guidance on acceptance of foreign clinical trials *

USA - April 23 2012
Over the last decade, drug, device, and biotechnology companies have taken their demand for clinical trial work to the global marketplace — vastly increasing the number of trials taking place outside of the United States.

Co-authors: Anne L. Hanson.

---

Opening the door for generic biologics: FDA releases the first guidance documents implementing the biosimilar approval pathway *

USA - February 16 2012
Therapeutic biologic products are at the forefront of medical research and provide promising treatments for a variety of medical conditions.

Co-authors: Amy Gaither, John R. Manthei.

---

The Institute of Medicine recommends FDA abandon the 510(k) premarket clearance process *

USA - August 2 2011
In September 2009, the US Food and Drug Administration (FDA or Agency) requested that the Institute of Medicine (IOM) evaluate the premarket clearance process for medical devices set forth in section 510(k) of the Federal Food, Drug and Cosmetic Act.

Co-authors: Eric Greig, John R. Manthei, Elizabeth M. Richards.

---