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Health Care Providers › Over The Counter Drugs (OTC) › Food and Drug Administration (FDA)

Sheppard Mullin Richter & Hampton LLP

Reminder: FDA Does, In Fact, Review DOF

Sheppard Mullin Richter & Hampton LLP on

When was the last time you thought about “data on file” (“DOF”)? Probably not recently, but last week, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) posted an untitled letter (the...more

McDermott Will & Schulte

Healthcare Regulatory Check-up Newsletter | July 2023 Recap

McDermott Will & Schulte on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for July 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act...more

King & Spalding

A New Day (And A New Acronym) For OTC Drugs

King & Spalding on

The expansion of over-the-counter (“OTC”) drug options has been a long time coming. Advocates in various fora, including within the U.S. Food and Drug Administration (“FDA” or the “Agency”), have focused on the potential for...more

Mintz - Health Care Viewpoints

Will a Nonprescription Birth Control Pill Be FDA’s First Approval under its Long-Awaited “ANCU” Proposed Rule?

Mintz - Health Care Viewpoints on

Unintended downstream consequences are likely to abound in the wake of the June 24, 2022 Dobbs decision that overruled Roe v. Wade, as Mintz attorneys have addressed in other contexts here and here Those looking ahead have...more

American Conference Institute (ACI)

[Event] Drug & Medical Device Litigation - December 7th - 8th, New York, NY

American Conference Institute (ACI) on

The premier event for drug and medical device product liability lawyers to gain essential winning litigation strategies. ACI’s 26th Annual Flagship Conference on Drug and Medical Device Litigation is returning to New York...more

Wilson Sonsini Goodrich & Rosati

FDA Reaches Another Milestone in COVID-19 Diagnostic Testing: First Over-the-Counter COVID-19 Home Test

Wilson Sonsini Goodrich & Rosati on

On December 15, 2020, the U.S. Food and Drug Administration (FDA) finally issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home...more

Mintz - Health Care Viewpoints

An Update on FDA’s Contribution to COVID-19 Diagnostic Testing

Mintz - Health Care Viewpoints on

Back in the early days of the COVID-19 pandemic, we published a post outlining the different kinds of diagnostic tests that were being marketed and the different roles of the two main federal regulators that oversee the...more

Holland & Knight LLP

EPA's New Prescription for Pharmaceutical Waste

Holland & Knight LLP on

• The U.S. Environmental Protection Agency (EPA) has published a new rule to address the handling, storage, transportation and disposal of hazardous waste pharmaceuticals by healthcare facilities and reverse distributors. •...more

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