AG/FDA Blog

FDA Updates Its Guidance on Prior Notice of Imported Foods

The Food and Drug Administration (FDA) has published an updated guidance document, Draft Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 3).  This draft guidance is being distributed for comment purposes only.  A… Read More
Read More

Draft Methodological Approach for Designating High-Risk Foods -- Comment Period Extended

The Food and Drug Administration (FDA) has published notice of a 45-day extension, until May 22, 2014, of the comment period on its Draft Methodological Approach to Identifying High-Risk Foods under Section 204(d)(2) of FSMA.  79 Fed. Reg. 16,800 (M… Read More
Read More

Intentional Adulteration – Comment Period Extended

The Food and Drug Administration (FDA) has published notice of a 90-day extension, until June 30, 2014, of the comment period on its proposed rule addressing intentional adulteration of food and on an associated draft document, both published in the… Read More
Read More

John Block Reports: FDA’s New Nutrition Label—Proposal to Demonize Sugar

OFW Law founding principal Richard L. Frank fills in for former USDA Secretary John R. Block on John Block Reports. Several weeks [ago], the Food and Drug Administration (FDA) issued its first major proposal in 20 years to amend the Nutrition Fac… Read More
Read More

Food Security from the Tractor Seat

Last week’s headlines announced the arrival of higher food prices with more increases to come because of widespread drought in California and Texas.  Talk of climate change and its effect on food production in some circles has taken on a new sense… Read More
Read More

“Time”-ly Tip from Dr. Doom

There has been a great deal of noise in the media recently about “plants running without inspection” and the significance to both the establishment and to FSIS. It is important to remember that no operations requiring inspection shall be conducte… Read More
Read More

FDA denies Remodulin® Citizen Petition; Treprostinil Injection ANDAs can proceed with labeling carve-out

Last week, FDA announced the latest in a line of decisions demonstrating the agency’s continued support for approval of generic drugs with labeling that “carves-out” information protected by a brand drug’s patents or marketing exclusivity. Se… Read More
Read More

FDA Issues Statement on GRAS Determination of Senomyx

By Mark L. Itzkoff On March 12, 2014, FDA issued an unusual statement regarding the GRAS status of a new flavor ingredient.  FDA issued the statement in response to a March 11 press release from Senomyx regarding the GRAS status of a new flavor ing… Read More
Read More

U.S. Supreme Court Extends Sarbanes-Oxley Whistleblower Protection to Employees of Privately-Held Companies

On March 4, 2014, the U.S. Supreme Court ruled in Lawson v. FMR LLC, No. 12-3 that “whistleblower” protection under the Sarbanes-Oxley Act of 2002 extends to the employees of a public company’s private contractors and subcontractor… Read More
Read More

Good Reprint Practices Revamped

By Casper E. Uldriks The Food and Drug Administration (FDA) issued a revised draft guidance document in February 2014 entitled, “Guidance for Industry: Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practi… Read More
Read More

Follow Blog Via Email

Enter your email address to subscribe to this blog and receive notifications of new posts by email.