Rebecca Dandeker

Nov 12, 2024 | jdsupra.com | Jacqueline R. Berman |Michele L. Buenafe |Rebecca Dandeker

The reelection of former President Donald Trump, coupled with Republicans gaining the Senate majority and poised to gain the House majority, has prompted many in the life sciences industry to question how this political shift may impact the regulation of drugs, devices, and other life sciences products by FDA and related regulators.

Nov 8, 2024 | morganlewis.com | Jacqueline R. Berman |Michele L. Buenafe |Rebecca Dandeker |Dennis Gucciardo

The reelection of former President Donald Trump, coupled with Republicans gaining the Senate majority and poised to gain the House majority, has prompted many in the life sciences industry to question how this political shift may impact the regulation of drugs, devices, and other life sciences products by FDA and related regulators.

Jan 15, 2024 | jdsupra.com | Rebecca Dandeker |Alexandre Gapihan

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) brought significant changes for the US Food and Drug Administration’s (FDA’s) regulation of cosmetic products. Recent FDA action, including the issuance of final guidance and a newly launched registration and listing portal, provide additional clarity as to what the agency’s approach to implementing MoCRA requirements will be in 2024.

Jan 12, 2024 | morganlewis.com | Rebecca Dandeker |Alexandre Gapihan

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) brought significant changes for the US Food and Drug Administration’s (FDA’s) regulation of cosmetic products. Recent FDA action, including the issuance of final guidance and a newly launched registration and listing portal, provide additional clarity as to what the agency’s approach to implementing MoCRA requirements will be in 2024.

Aug 10, 2023 | lexology.com | Kathleen M. Sanzo |Rebecca Dandeker |Alexandre Gapihan

The US Food and Drug Administration (FDA) has issued a draft guidance to assist “responsible persons” that are required to submit a cosmetic manufacturing facility registration and cosmetic product listing under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Every cosmetic manufacturer and private labeler will be required to make a submission regardless of prior participation in the previous voluntary registration program.