News & Analysis as of

New Guidance Reporting Requirements Pharmaceutical Industry

Robinson+Cole Health Law Diagnosis

HHS Publishes 340B Guidance Proposing Rebate Pilot Program

On July 31, 2025, the Department of Health and Human Services (HHS) announced a much-anticipated 340B Rebate Model Pilot Program (Pilot Program) via guidance (Guidance) that will be formally published on August 1, 2025. The...more

Paul Hastings LLP

Public Company Watch: December 2023

Paul Hastings LLP on

In the December Public Company Watch, we cover key issues impacting public companies, including a preview of the SEC’s latest regulatory agenda, an update regarding the Fifth Circuit vacating the SEC’s share repurchase rules,...more

Smart & Biggar

New guidance documents and regulatory amendments regarding therapeutic product shortages

Smart & Biggar on

As we have previously reported, in response to the COVID-19 pandemic, the Minister of Health had made interim orders pursuant to the Food and Drugs Act to address the significant risk to health posed by shortages in 2020 and...more

Robinson+Cole Health Law Diagnosis

FDA Enhances PMSR For Combination Products

On March 21, 2018, the Food and Drug Administration (FDA) published two guidance documents addressing postmarketing safety reporting requirements (PMSR) for combination products.  The FDA had previously issued a Final Rule on...more

Cooley LLP

Blog: CMS Announces Updated Guidance Related to CME Reporting and Issues New Sunshine FAQs

Cooley LLP on

Last week, the Centers for Medicare & Medicaid Services (CMS) announced that it updated its Open Payments Law and Policy webpage and issued 3 frequently asked questions (FAQs) related to the reporting of payments and...more

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