News & Analysis as of

New Guidance Supply Chain Food and Drug Administration (FDA)

Hogan Lovells

FDA finalizes RRA manufacturing inspection guidance as US focuses on supply chain security

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently issued final guidance entitled “Conducting Remote Regulatory Assessments,” which explains the agency's plans to continue utilizing its records request authority and virtual...more

ArentFox Schiff

FDA’s Remote Regulatory Assessments Enhance DSCSA Compliance With Technology-Driven Oversight

ArentFox Schiff on

On June 25, the US Food and Drug Administration (FDA) released a final guidance, “Conducting Remote Regulatory Assessments: Question and Answers.”...more

Katten Muchin Rosenman LLP

FDA Requesting Comments on Proposed Guidance Regarding 510(k) Transfers

On June 5, 2025, the U.S. Food and Drug Administration (“FDA”) issued draft guidance (the “510(k) Transfer Guidance”) related to the transfer of a Premarket Notification (510(k)) Clearance. The 510(k) Transfer Guidance...more

Quarles & Brady LLP

FDA Releases Declaratory Order Regarding Tirzepatide Shortage

Quarles & Brady LLP on

The FDA released a Declaratory Order on December 19th re-evaluating and essentially re-instituting its previous position on the tirzepatide shortage, declaring the shortage resolved. As a bit of history, on October 2, 2024...more

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

Jones Day

FDA Announces Delayed Enforcement of Looming Supply Chain Requirements for Drugs Until 2024

Jones Day on

With a November 2023 compliance deadline fast approaching, FDA publishes guidance explaining a one-year delayed enforcement of certain obligations, including interoperable, electronic, and package-level product tracing...more

Nelson Mullins Riley & Scarborough LLP

Two new FDA Drug Supply Chain Security Act Guidances to help Pharmaceutical Supply Chain Partners Comply with the DSCSA’s move to...

The DSCSA, enacted in 2013, requires entities in the pharmaceutical supply chain to implement security measures to prevent the introduction of counterfeit and illegitimate drugs into the market. One of these measures is the...more

Quarles & Brady LLP

More Guidance Released from FDA for Drug Supply Chain Security Act Compliance

Quarles & Brady LLP on

The Food and Drug Administration (“FDA”) released additional guidance documents on Wednesday, August 30th pertaining to the enhanced drug distribution security requirements under the Drug Supply Chain Security Act (“DSCSA”). ...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

American Conference Institute (ACI)

[Event] 7th Advanced Summit on Food Law – Regulation, Compliance and Litigation - April 18th - 19th, Chicago, IL

American Conference Institute is hosting the 7th Annual Advanced Summit on Food Law – Regulation, Compliance, and Litigation from April 18-19, 2023, in Chicago! Prepare for the future by examining current controversies,...more

Morgan Lewis - As Prescribed

Tracking Back to Track and Trace: Additional Guidance on Compliance with the DSCSA

Earlier in the summer, the FDA issued a quartet of guidance documents setting forth the Agency’s plan for implementing requirements under the Drug Supply Chain Security Act (DSCSA). The DSCSA directs FDA to build an...more

American Conference Institute (ACI)

[Virtual Event] Dietary Supplements - June 23rd - 24th, 8:30 am - 3:45 pm EDT

Join key industry stakeholders to discuss the latest developments affecting the dietary supplement industry. Now in a Virtual Format. American Conference Institute (ACI) together with the Council for Responsible Nutrition...more

Foley Hoag LLP

COVID-19 Supply Chain and Trade Update #3

Foley Hoag LLP on

Foley Hoag’s Trade Sanctions & Export Controls Practice offers experienced, proactive regulatory advice to help clients avoid regulatory compliance missteps and to prevail in official proceedings. Included in this Issue: ...more

McDermott Will & Schulte

FDA Update: COVID-19 Testing, Vaccine Development and Other Impacts

In response to the United States’ rapidly evolving public health situation, the US Food and Drug Administration (FDA) recently released guidance on high-complexity in vitro diagnostic (IVD) tests for COVID-19. This article...more

Morgan Lewis

Recent FDA Medical Device Developments in Response to COVID-19

Morgan Lewis on

The US Food and Drug Administration is working to facilitate emergency use authorization for coronavirus (COVID-19) medical devices, including diagnostic tests and respirators, while also working with the Federal Trade...more

Holland & Knight LLP

FDA Guidance on DSCSA Product Identifier Requirements

Holland & Knight LLP on

Members of the pharmaceutical supply chain, including drug wholesalers and manufacturers, are grappling with fast-approaching deadlines for compliance with new federal regulatory requirements. The Drug Quality and Security...more

Mintz - Health Care Viewpoints

FDA Provides 11th Hour Delay of Product Tracing Requirements for Pharmacies

On June 30, 2015, a mere day before the product tracing deadline for dispensers was to go into effect, FDA published a compliance policy guidance that delays enforcement of the applicable product tracing requirements until...more

Womble Bond Dickinson

FDA Gives Food Industry Three Years to Phase Out Partially Hydrogenated Oils from Food Products

Womble Bond Dickinson on

On June 16, 2015, the Food and Drug Administration ("FDA") issued a declaratory order, requiring a phasing out of the use of partially hydrogenated oils ("PHOs"). In its order, the FDA stated that partially hydrogenated oils...more

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