News & Analysis as of

Food and Drug Administration (FDA) Working Groups

Akin Gump Strauss Hauer & Feld LLP

FDA Harshes the CBD Buzz; is it High Time for Congress to Step In?

The U.S. Food and Drug Administration (FDA) announced the conclusion of an internal working group that cannabidiol (CBD) will require a new regulatory pathway. The FDA explicitly denied three citizen petitions urging the...more

Seyfarth Shaw LLP

CBD is Everywhere – But Where Does the FDA Stand?

Seyfarth Shaw LLP on

Seyfarth Synopsis: CBD is “thriving” in the current regulatory environment, but is it doing so illegally? As former U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb opined last week, “the CBD craze is...more

Hogan Lovells

Will FDA be forced to implement a drug importation program?

Hogan Lovells on

Over a year ago, HHS Secretary Alex Azar requested that FDA establish a working group to explore how drug importation “could help address price hikes and supply disruptions.” The FDA working group was not assigned the task of...more

Kelley Drye & Warren LLP

H.R. 3985 Calls For Public-Private Working Group to Study Medical Device Security

Kelley Drye & Warren LLP on

The “Internet of Medical Things Resiliency Partnership Act of 2017” was introduced in the House of Representative earlier this month. Co-sponsored by Rep. David Trott (R-MI) and Rep. Susan Brooks (R-IN), the bill would...more

Mintz - Consumer Product Safety Viewpoints

Administration’s Biotechnology Working Group Updates Coordinated Framework & Unveils National Strategy

After launching with an ambitious agenda fourteen months ago, last Friday the Obama Administration announced that its Biotechnology Working Group had completed its two main tasks. The Working Group has proposed an Update to...more

Bergeson & Campbell, P.C.

Biotechnology: White House Directs EPA, FDA, and USDA to Update the Coordinated Framework for the Regulation of Biotechnology

With little fanfare or advanced notice to the general public, on July 2, 2015, the White House Office of Science and Technology Policy (OSTP), the Office of Management and Budget (OMB), the U.S. Trade Representative, and the...more

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