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OIG Issues Advisory Opinion Allowing Pharmaceutical Company’s Payment of Travel, Food and Lodging Expenses for Indigent and Rural...

In its final Advisory Opinion of 2020, the U.S. Department of Health and Human Services Office of Inspector General (OIG) approved a pharmaceutical company’s request to provide financial assistance to patients who were...more

FDA Issues Guidance for Applicants Seeking Biosimilar/Interchangeable Approval

The Food and Drug Administration (FDA) released new draft guidance, Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act, intended for prospective applicants of biologics...more

Did the OIG Just End In-Person Speaker Programs?

On November 16, 2020, the Department of Health and Human Services, Office of Inspector General (OIG) published a Special Fraud Alert for Speaker Programs. The Special Fraud Alert "highlights some of the inherent fraud and...more

Pacira Pharmaceuticals Pays $3.5M to Settle Allegations of Using Grants as Kickbacks

On July 28, 2020, the Department of Justice (DOJ) announced a $3.5 million settlement to resolve allegations against Pacira Pharmaceuticals Inc. that it paid kickbacks to doctors in the form of “bogus” research grants to...more

FDA Amends Imported Non-NIOSH Approved Respirator EUA

In a June 6 Letter of Authorization (LoA), the U.S. Food and Drug Administration (FDA) reissued its March 28 LoA to revise emergency use authorization (EUA) eligibility criteria for imported, non-National Institute for...more

FDA Revises Enforcement Policy for Face Masks and Respirators

On May 26, 2020, the United States Food and Drug Administration (FDA) revised its Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency, which supersedes the...more

FDA Revises EUA Criteria for Respirators Manufactured in China (Updated)

In a June 6 Letter of Authorization (LoA) regarding the emergency use authorization (EUA) for non-National Institute for Occupational Safety and Health (NIOSH)-approved disposable filtering facepiece respirators manufactured...more

FDA Issues EUA to Increase Availability of Non-Surgical Gowns and Other Apparel

On May 22, 2020, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) in response to concerns relating to insufficient supply and availability of non-surgical gowns and other apparel for use by...more

FDA Revises EUA Criteria for Respirators Manufactured in China

In a May 7 Letter of Authorization (LoA), the U.S. Food and Drug Administration (FDA) reissued its April 3 LoA with revised eligibility EUA criteria for non-NIOSH-approved disposable filtering facepiece respirators...more

FDA Grants EUA for General Purpose Face Masks and Continues to Address PPE Shortage

On April 18, 2020, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for face masks in its continuing effort to address shortages of the personal protective equipment (PPE). This most recent...more

China’s Latest Measures for Medical Equipment Exports

In recent weeks, the Chinese government has faced criticism from governments around the world about the quality of medical equipment manufactured in China. In response, the Chinese government has adopted measures to...more

Another Step in Expanding Personal Protective Equipment: FDA Extends EUA to Face Shields

The Food and Drug Administration (FDA) issued on April 9, 2020 its first emergency use authorization (EUA) for face shields to address the significant shortage of personal protective equipment (PPE) during the COVID-19...more

FDA Opens Door to Respirators From Chinese Manufacturers, Revises Respirator Enforcement Policy

On April 3, 2020, the Food and Drug Administration (FDA) issued a new emergency use authorization (EUA) for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China. This EUA supplements the...more

FDA Eases Regulations On Face Masks And Respirators During COVID-19 Pandemic

On March 25, 2020, the Food and Drug Administration (FDA) issued a detail-rich guidance about its “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency” with the...more

FDA Issues Emergency Use Authorization for Ventilators, Tubing Connectors and Accessories

The Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as...more

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