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2 weeks ago | 
jdsupra.com | Brigid DeCoursey Bondoc |Lena Gankin |Brian Sylvester
On April 22, 2025, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) announced a major initiative to voluntarily phase out “petroleum-based synthetic dyes” (i.e., synthetic color additives) from the U.S. food supply. This FDA initiative is part of the broader trend of increased scrutiny of food and color additive safety at the state and federal levels.
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Jan 28, 2025 | 
jdsupra.com | Brigid DeCoursey Bondoc |Adam L. Braverman |Kate Driscoll
In 2024, as in years past, healthcare fraud enforcement by the U.S. Department of Justice (DOJ) was substantial. Federal actions under the False Claims Act (FCA) alone resulted in $1.67 billion in settlements and judgments from managed care providers, hospitals and other medical facilities, pharmacies, pharmaceutical companies, laboratories, and physicians.
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Jan 22, 2025 | 
jdsupra.com | Brigid DeCoursey Bondoc |Adam L. Braverman |Kate Driscoll
The Department of Justice published its False Claims Act (FCA) statistics for Fiscal Year 2024 this month, revealing a nearly 40% increase in whistleblower filings, increased recoveries year over year, and a near record number of settlements and judgments. Key takeaways include the following: FCA settlements and judgments exceeded $2.9 billion in FY 2024, an increase from the $2.68 billion recovered in FY 2023.
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Jan 10, 2024 | 
jdsupra.com | Brigid DeCoursey Bondoc |Adam L. Braverman |Kate Driscoll
The year 2023 was a busy one for regulatory, compliance, and enforcement developments in the healthcare and life sciences industries, and 2024 promises to be even busier.
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Jan 10, 2024 | 
lexology.com | Adam L. Braverman |Kate Driscoll |Nathaniel Mendell |Brigid DeCoursey Bondoc
The year 2023 was a busy one for regulatory, compliance, and enforcement developments in the healthcare and life sciences industries, and 2024 promises to be even busier.
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Nov 13, 2023 | 
lexology.com | Lisa Silverman |Brigid DeCoursey Bondoc |David Shaw |Qiwen Zhong
In the latest attempt to promote generic drug competition and reduce drug prices, and consistent with broader efforts to enforce the antitrust laws more aggressively, the Federal Trade Commission (FTC) announced on November 7, 2023, challenges to more than 100 patent listings by brand drug manufacturers in the Food and Drug Administration’s (FDA) Orange Book. The challenges implicate 62 unique patents and 18 FDA approved products.
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Oct 25, 2023 | 
jdsupra.com | Brigid DeCoursey Bondoc
Last week, the U.S. Food and Drug Administration (FDA) published its new guidance on the Development and Licensure of Vaccines to Prevent COVID-19 (the “Guidance”). FDA provided a preview of a new COVID-19 vaccines guidance back in March 2023, when it announced that the current policy on Emergency Use Authorizations (EUAs) for COVID-19 vaccines would expire on November 7, 2023, unless superseded by another policy before that date.
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Oct 24, 2023 | 
lexology.com | Brigid DeCoursey Bondoc
Last week, the U.S. Food and Drug Administration (FDA) published its new guidance on the Development and Licensure of Vaccines to Prevent COVID-19 (the “Guidance”). FDA provided a preview of a new COVID-19 vaccines guidance back in March 2023, when it announced that the current policy on Emergency Use Authorizations (EUAs) for COVID-19 vaccines would expire on November 7, 2023, unless superseded by another policy before that date.
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Sep 1, 2023 | 
mondaq.com | Brigid DeCoursey Bondoc
Brigid Bondoc spoke to BioWorld about the U.S. Food and
Drug Administration's draft guidance for predetermined change
control protocols (PCCPs).
According to Brigid, developers don't need to be utterly
averse to including a proposed change to the indication for use in
a PCCP program.
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Jul 28, 2023 | 
mondaq.com | Brigid DeCoursey Bondoc
Brigid Bondoc spoke to Pink Sheet about the U.S. Food
and Drug Administration's draft guidance on decentralized
clinical trials, which describes when investigators can delegate
trial-related activities to local health care providers.
