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FDA
FDA Extends Wait for Biosimilar Interchangeability Guidance
The United States Food and Drug Administration (FDA) was expected to release interchangeability guidance on biosimilars sometime…
FDA Releases Draft Guidance on Manufacturer Communications with Payors,…
In mid-January 2017, the United States Food and Drug Administration (FDA) released a guidance document, entitled “Drug and Device…
FDA Releases Draft Guidance for Medical Product Communications Consistent…
The United States Food and Drug Administration (FDA) released a new draft guidance that provides information for medical product…
FDA Releases Draft Guidance for Industry on Biosimilar Interchangeability
On January 17, 2017, the Food and Drug Administration (FDA) released a draft guidance intended to assist sponsors in demonstrating…
Interim FDA Commissioner Announced
Dr. Robert Califf’s tenure as commissioner of the United States Food and Drug Administration (FDA) is slated to come to an end…
FDA Releases Draft Guidance for Medical Product Communications Consistent…
The United States Food and Drug Administration (FDA) released a new draft guidance that provides information for medical product…
FDA Issues Guidance on REMS
With the passage of the long-awaited 21st Century Cures legislation, we saw Senator Mike Lee (R-UT) vote “no” because the bill did…
FDA Seeking Comments on Direct to Consumer Advertising Proposed Research
On January 4, 2017, the United States Food and Drug Administration (FDA) published a Notice in the Federal Register, requesting…
FDA Plans to Study Social Media Promotion
On November 7, 2016, the Food and Drug Administration (FDA) announced its plan to research methods for including risk information…
21st Century Bill Headed to President Obama’s Desk
Nearly three years after its initial introduction, the 21st Century Cures Act has finally passed both houses of the Congress, and…