FDA says its authority to implement the TCA is not limited by Loper Bright, but suggests that future guidance documents may be limited.
On August 26, 2024, the US Food and Drug Administration (FDA or the Agency) filed its...more
9/10/2024
/ Administrative Procedure Act ,
Chevron Deference ,
E-Cigarettes ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Life Sciences ,
Loper Bright Enterprises v Raimondo ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Authority ,
Statutory Interpretation ,
Tobacco ,
Tobacco Regulations
The proposed rule, if finalized, would impose new manufacturing practice requirements on foreign and domestic manufacturers of finished and bulk tobacco products.
On March 10, 2023, the Food and Drug Administration (FDA...more
FDA provides recommendations on sources of cannabis in clinical research, resources for information on quality, and control status considerations under the Controlled Substances Act.
Key Points:
..The Food and Drug...more
The Agency plays a significant role in the evolving legal landscape governing certain cannabis-derived products.
Key Points:
..New law lifts or eases some, but not all, federal obstacles for certain cannabis-derived...more
5/9/2019
/ Agricultural Sector ,
Cannabidiol (CBD) oil ,
Comment Period ,
Controlled Substances Act ,
Enforcement Authority ,
Farm Bill ,
Food and Drug Administration (FDA) ,
Hemp ,
Marijuana ,
Marijuana Cultivation ,
Public Hearing
Agency works to speed approvals and improve access to generic prescription drugs.
In recent weeks, the US Food and Drug Administration (FDA or the Agency) has taken a series of steps — under FDA Commissioner Scott...more
Agency outlines flexible, case-by-case approach to demonstrating interchangeability to reference products; emphasizes role of “switching studies” -
On January 18, 2017, the US Food and Drug Administration (FDA or...more
The act creates faster, more flexible FDA drug and biologic review, new drug and device approval pathways, increases FDA funding, and reduces EHR administrative burdens.
On December 13, 2016, President Obama signed into...more
New rules affecting new drug application holders and follow-on applicants will take effect on December 5, 2016.
On October 6, 2016, the US Food & Drug Administration (FDA or the Agency) published a 79-page final rule...more
Manufacturers and retailers must receive premarket authorization for newly deemed tobacco products and comply with other requirements related to FDA’s long-anticipated deeming rule.
On May 10, 2016, the U.S. Food and...more
In the wake of a new Medicare reimbursement framework, FDA plans stricter regulation of some in vitro diagnostic devices.
On July 31, 2014, the U.S. Food and Drug Administration (FDA; Agency) announced its intent to...more