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Reporting Requirements Proposed Rules Medical Devices

Blake, Cassels & Graydon LLP

Santé Canada propose un règlement visant à atténuer les pénuries de drogues et d’instruments médicaux

Santé Canada a récemment publié un projet de règlement visant à pallier les pénuries de produits thérapeutiques au Canada. Le Règlement modifiant certains règlements pris en vertu de la Loi sur les aliments et drogues...more

Smart & Biggar

Health Canada proposes to amend the Food and Drug Regulations and Medical Devices Regulations to address shortages

Smart & Biggar on

On December 28, 2024, Health Canada published proposed amendments to the Food and Drug Regulations and Medical Devices Regulations to address therapeutic product shortages (see our previous article regarding Health Canada’s...more

Stikeman Elliott LLP

New Regulatory Amendments Under the Food and Drugs Act: Addressing Drug and Medical Device Shortages in Canada

Stikeman Elliott LLP on

On December 28, 2024, Health Canada published a regulatory proposal in the Canada Gazette, Part I, Volume 158, Number 52, introducing amendments to the Food and Drug Regulations, CRC, c 870 and the Medical Devices...more

King & Spalding

FDA's Latest Salvo in the LDT Wars

King & Spalding on

On September 29, 2023, the Food & Drug Administration (“FDA” or the “Agency”) published the long-awaited proposed rule on laboratory developed tests (“LDT Proposed Rule”). The proposed rule is open for public comment through...more

Akin Gump Strauss Hauer & Feld LLP

CMS Issues Proposed Revisions to Open Payments/Sunshine Act Reporting Requirements

• On July 29, 2019, CMS released its proposed 2020 Physician Fee Schedule rule, which includes the much anticipated proposed regulatory changes to the Sunshine Act/Open Payments program (“Open Payments”). The proposed...more

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