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Pharmaceutical Industry › Food and Drug Administration (FDA) › Waivers

Epstein Becker & Green

FDA Guidance on DSCSA Small Dispenser Exemption and Exemptions and Waivers for Other Trading Partners

Epstein Becker & Green on

In June 2024, the U.S. Food and Drug Administration ("FDA") clarified, with respect to the Drug Supply Chain Security Act (“DSCSA”), that it will not extend the one-year stabilization period for the enhanced drug distribution...more

Quarles & Brady LLP

FDA Announces Guidance for DSCSA Process to Request a Waiver, Exception, or Exemption

Quarles & Brady LLP on

On Friday, August 4th, the Food and Drug Administration (“FDA”) announced the availability of a final guidance document, titled “Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food,...more

King & Spalding

And So It Begins: House Energy and Commerce Leaders Unveil FDA User Fees Legislative Package

King & Spalding on

On May 4, 2022, House Energy and Commerce (“E&C”) Committee leaders unveiled the legislative package to reauthorize the U.S. Food and Drug Administration (“FDA” or the “Agency”) user fee agreements (the “House Draft”)...more

Goodwin

FDA Answers New Questions on Foreign Trial Sites Operating Under INDs

Goodwin on

On May 19, 2021, the U.S. Food and Drug Administration (FDA) released an updated guidance in draft form on how to complete the Statement of Investigator form (Form FDA 1572). The guidance addresses frequently asked questions...more

Akin Gump Strauss Hauer & Feld LLP

Executive Order on Essential Medicines: A Timeline and Overview of Key Provisions

Akin Gump Strauss Hauer & Feld LLP on

On August 6, President Trump issued an Executive Order (EO) titled “Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs Are Made in the United States.” The far-reaching EO seeks to ensure the domestic...more

Hogan Lovells

FDA permits waivers of some REMS-required laboratory tests, imaging studies due to COVID-19

Hogan Lovells on

On March 22, the U.S. Food and Drug Administration (FDA) published the guidance “Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency,” in which the agency recognizes that completion of laboratory...more

Bricker Graydon LLP

FDA proposes waiver of informed consent requirements for minimal risk trials

Bricker Graydon LLP on

On November 15, 2018, the Food and Drug Administration (FDA) published a Proposed Rule to amend its regulations to allow waiver or alteration of informed consent requirements in certain FDA-regulated clinical investigations...more

K&L Gates LLP

K&L Gates Triage: REMS…Sharing is so hard to do

K&L Gates LLP on

The U.S. Food and Drug Administration (FDA) recently released two draft guidance documents related to its requirement for shared risk evaluation and mitigation strategies (REMS) and the process for requesting a waiver of this...more

McGuireWoods LLP

Washington Healthcare Update

McGuireWoods LLP on

This Week: Bipartisan Senate Letter Questions HHS and CMS on Details of State ACA Waivers...OMB Is Reviewing Final Medicaid-Covered Outpatient Drug Rule...Delaware Forgoes Transition to State-Based Exchange....more

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