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Regulatory Oversight › Product Recalls

Morrison & Foerster LLP

Proactivity in Product Safety: Best Practices for Compliance

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Consumer product companies are facing unprecedented scrutiny as the Consumer Product Safety Commission (CPSC) intensifies its regulatory oversight. With heightened civil penalties, increased monitoring of e-commerce...more

Morrison & Foerster LLP

CPSC’s 2024 Year in Review

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In recent years, the Consumer Product Safety Commission (CPSC) has increased pressure on consumer product companies through various enforcement mechanisms. The increase in the frequency and amount of civil penalties sought by...more

McDermott Will & Emery

FDA Issues Final Guidance for Initiation of Voluntary Recalls

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The US Food and Drug Administration (FDA) published its Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C: Guidance for Industry and FDA Staff (final guidance) on March 4, 2022. The final guidance describes how...more

American Conference Institute (ACI)

[Virtual Event] 36th Annual FDA Boot Camp - March 24th - 25th, 8:15 am - 1:45 pm EDT

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ACI’s FDA Boot Camp returns in a completely interactive virtual format to help life sciences attorneys and executives to master the fundamentals of FDA Regulation... Gain essential working knowledge of core FDA concepts,...more

Mintz - Health Care Viewpoints

Telemedicine Platform Recalled Over Failure to Obtain Pre-Market Clearance or Approval from FDA

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On August 8, 2019, FDA issued a notice on its medical device recall database stating that a company called Opternative, Inc. had initiated a recall for the Visibly Online Refractive Vision Test, a software application offered...more

Hogan Lovells

New FDA draft guidance on voluntary recalls highlights importance of recall initiation plans

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On April 23, FDA issued draft guidance entitled “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C,” which aims to clarify how firms in a product distribution chain should prepare to facilitate timely initiation...more

Stinson LLP

Cosmetics Regulation: Where It Is and Where It May Be Going

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On March 5, the U.S. Food and Drug Administration (FDA) simultaneously published its independent testing results confirming the presence of asbestos in certain cosmetic products sold by Claire’s and by the girls'...more

Hogan Lovells

FDA issues final guidance for public warnings and notification of recalls

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The U.S. Food and Drug Administration (FDA) recently issued a final guidance document regarding the use, content, and circumstances for the issuance of public warnings and public notifications for firm-initiated or...more

Hogan Lovells

FDA Enforcement Activities Update for FY 2016: CDRH Warning Letters Fall to 8-Year Low

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The Food and Drug Administration (FDA) recently released statitistics regarding its enforcement actvities for FY 2016. Of note, the number of warning letters issued by the Center for Devices and Radiological Health (CDRH),...more

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