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Food and Drug Administration (FDA) › Enforcement Authority

American Conference Institute (ACI)

[Event] 42nd FDA Boot Camp - March 13th - 14th, New York, NY

American Conference Institute (ACI) on

ACI’s FDA Boot Camp – now in its 42nd iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under the Food and Drug Omnibus Reform Act (FDORA). This...more

American Conference Institute (ACI)

[Event] 41st FDA Boot Camp - September 20th - 21st, Boston, MA

American Conference Institute (ACI) on

ACI’s FDA Boot Camp is back in Boston! This essential training course – now in its 41st iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under...more

American Conference Institute (ACI)

[Virtual Conference] FDA Boot Camp - September 14th - 15th, 8:15 am - 1:30 pm EST

American Conference Institute (ACI) on

Through nearly 19 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA regulation. Don’t miss your opportunity to join their ranks....more

Mintz - Health Care Viewpoints

DOJ Announces Another Wide-Ranging COVID-19 Fraud Enforcement Action

Mintz - Health Care Viewpoints on

For the last few years, we have been closely monitoring and reporting on COVID-19 related fraud enforcement efforts by federal agencies. We detailed those findings in our Health Care Enforcement 2020 Year in Review & 2021...more

Ervin Cohen & Jessup LLP

Will The FDA Enforce Its New Nutrition Labeling Rule? 

Ervin Cohen & Jessup LLP on

On September 18, 2020, the U.S. Food and Drug Administration announced additional flexibility for manufacturers to comply with the agency’s updated Nutrition and Supplement Facts labeling requirements. Those requirements go...more

Hogan Lovells

FDA extends enforcement discretion period for regenerative medicines, citing COVID-19 challenges

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) extended the enforcement discretion period for certain human cell, tissue, and cellular and tissue-based products (HCT/Ps) by an additional six months, citing the challenges...more

Holland & Hart LLP

FDA Cracks Down on Pet Products Containing CBD After USDA Clears Path for Hemp Production

Holland & Hart LLP on

Although more and more pet owners are turning to CBD products to treat their pets, new action by the FDA is a stark reminder that those CBD pet products found on-line and in stores are considered illegal at the federal level....more

Epstein Becker & Green

After Decades of Broad Enforcement Discretion, FDA Signals New Approach to Homeopathic Drugs

Epstein Becker & Green on

Two announcements made by FDA in late October signal a marked change to FDA’s regulatory approach to “homeopathic” drugs. On October 25, 2019, FDA withdrew the 1988 Compliance Policy Guide (“CPG”) 400.400 Conditions Under...more

Latham & Watkins LLP

Legalization of Products Containing CBD? Not Quite Yet, Says FDA

Latham & Watkins LLP on

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

Hogan Lovells

FDA Announces Produce Safety Rule Enforcement Discretion Policy for Almonds, Pulse Crops, Wine Grapes, and Hops under FSMA

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) has issued Guidance detailing its intent to exercise enforcement discretion for the requirements of the Produce Safety rule as they apply to entities growing, harvesting, packing,...more

Akin Gump Strauss Hauer & Feld LLP

DOJ Limits Use of Guidance Documents in Affirmative Civil Enforcement Actions

Akin Gump Strauss Hauer & Feld LLP on

On January 25, 2018, the Associate Attorney General directed the Department of Justice (DOJ) not to rely on agency guidance documents to establish a violation in affirmative civil enforcement (“ACE”) cases. She issued the...more

Mintz - Consumer Product Safety Viewpoints

Eighth Circuit Issues Decision Significant for All Executives of FDA-Regulated Businesses

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On July 6, 2016, the Eighth Circuit Court of Appeals issued its ruling in United States v. DeCoster, in which it upheld prison sentences for two executives under the “responsible corporate officer” (RCO) doctrine of...more

Davis Wright Tremaine LLP

FDA Issues Draft Guidance for Mandatory Recall Authority

Davis Wright Tremaine LLP on

On Thursday, May 7, 2015, the FDA released draft guidance on the implementation of its mandatory recall authority. The guidance itself is not binding on food companies, but provides more information about the FDA’s recall...more

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