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FDA Medical Device User Fee Rates for FY 2024

The Food and Drug Administration (FDA) has posted the Medical Device User Fee rates for Fiscal Year 2024. This notice provides the updated fee schedule for medical device manufacturers.

Routine Notice Medical Devices
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FDA Economic Analysis of CDRH Submission Requirements

The FDA has published an economic analysis concerning the submission requirements for the Center for Devices and Radiological Health (CDRH). This analysis provides insights into the economic impact of these requirements on medical device manufacturers.

Routine Notice Healthcare
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FDA PRIA Reference SBA Size Standards Update

The FDA has posted an update regarding the Presolicitation Information and Analysis (PRIA) Reference, specifically concerning Small Business Administration (SBA) size standards. This notice updates the reference document used by the agency for certain regulatory processes.

Routine Notice Healthcare
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FDA Guidance on Physicochemical Characterization of Topical Drug Products

The FDA has issued final guidance for industry on the physicochemical and structural characterization of topical drug products submitted in Abbreviated New Drug Applications (ANDAs). This guidance, which finalizes a draft from October 2022, provides recommendations to support bioequivalence demonstrations for generic topical products.

Routine Guidance Pharmaceuticals
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Vermont AG Charges Resident with Human Trafficking and Assault

The Vermont Attorney General's Office announced the arraignment of Richard Memoli, 69, on multiple felony and misdemeanor charges including human trafficking, sexual assault, and drug possession. The investigation was conducted by the Vergennes Police Department, and Mr. Memoli was ordered held without bail.

Urgent Enforcement Criminal Justice
9d ago AG: Michigan News
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Election Fraud Sentencing and Restitution Order

The Michigan Attorney General announced the sentencing of Shawn Wilmoth to 4 to 20 years in prison for conducting an election fraud criminal enterprise in the 2022 election cycle. Wilmoth was ordered to pay $376,601 in restitution to defrauded gubernatorial and judicial candidates.

Urgent Enforcement Criminal Justice
9d ago AG: Michigan News
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Former Nursing Assistant Charged with Stealing $9,000 from Elderly Resident

The Michigan Attorney General's office announced charges against Terrance Brown Jr., a former nursing assistant, for allegedly stealing nearly $9,000 from an elderly nursing home resident. Brown faces multiple felony charges related to larceny and financial transaction device fraud.

Urgent Enforcement Healthcare
9d ago AMF France News
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AMF France: Crowdfunding Platforms Reminded of Complaint Handling Rules

The AMF France has issued a reminder to crowdfunding service providers (CSPs) regarding their obligations for handling investor complaints. This guidance clarifies requirements under EU and AMF regulations for establishing and maintaining effective complaint handling systems.

Priority review Guidance Financial Services
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Gregorio et al v. Vivakor, Inc. - Civil Case Filing

A new civil case, Gregorio et al v. Vivakor, Inc., has been filed in the U.S. District Court for the Northern District of California. The case involves a complaint based on Federal Question and the Racketeer Influenced and Corrupt Organizations Act (RICO). The filing date was March 18, 2026.

Routine Enforcement Securities
9d ago DHS Press Releases
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ICE Arrests Child Predators, Sex Criminals, and Drug Traffickers

U.S. Immigration and Customs Enforcement (ICE) announced the arrest of multiple individuals convicted of serious crimes including child sexual assault, incest, and drug trafficking. The press release highlights the administration's focus on removing illegal aliens with criminal convictions.

Priority review Enforcement Immigration

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