2015, Healthcare, Manufacturing and Utilities

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2015

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It Takes Three [Components] to Make a Thing Go Riiiiiight – OPDP Challenges Two-Part Ad

FDA Law Blog

JANUARY 26, 2022

This content is likely one of the reasons for FDA’s withdrawal of the Draft Guidance in 2015 – the same year that FDA suffered one of the most significant blows regarding First Amendment protections for pharmaceutical manufacturer speech. Where FDA does not have jurisdiction, the agency may nevertheless take appropriate action (e.g.,

IT Education Utilities Patient-Centered

FDA-Approved Labeling: Is Enough Enough?

FDA Law Blog

AUGUST 21, 2023

Further, FDA has utilized a variety of strategies to call attention to safety issues through Dear Doctor letters or other forms of communication, even if directing changes to labeling is difficult. Plaintiffs alleged that Defendants had a duty under state law to warn consumers of a (potential) risk of prenatal exposure to acetaminophen.

Manufacturing

Manufacturing Consulting Healthcare Professional Vaccination

Primary Care Digest

It Takes Three [Components] to Make a Thing Go Riiiiiight – OPDP Challenges Two-Part Ad

FDA-Approved Labeling: Is Enough Enough?

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