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March 16, 2022March 16, 2022 by Duane Morris

FDA Final Guidance on Initiating Voluntary Recalls: Be “Recall Ready”

On March 4, 2022, FDA issued a final guidance to industry and FDA staff regarding the initiation of voluntary recalls under 21 CFR part 7, subpart C. The guidance applies to voluntary recalls of products subject to FDA’s jurisdiction, including any:

1. Food, drug and device (human or animal use);
2. Cosmetic and biological product (human use);
3. Tobacco product;
4. Item subject to a quarantine regulation under 21 CFR part 1240; and
5. Devices that are electronic products regulated as radiology devices (subject to 21 CFR part 892) but not electronic products subject to 21 CFR parts 1003 and 1004.

In short, the final guidance clarifies FDA’s recommendations on how a firm should be prepared to facilitate the timely initiation of voluntary recalls, steps a firm should take if there is an indication of a problem with a distributed product and how to initiate voluntary recalls. The final guidance also explains how FDA works with firms to initiate a voluntary recall.

To read the full text of this Duane Morris Alert, please visit the firm website.

September 27, 2021September 27, 2021 by Duane Morris

FDA Issues Final Rule on “Intended Use”

On August 2, 2021, the Food and Drug Administration issued its final rule modifying its regulations on the intended use of medical devices, prescription drugs and biologics. Most importantly, the final rule repeals the 2017 rule’s “knowing clause,” which seemed to imply that a party may be accountable for off-label use if the party “should have known” the product was likely to be used off-label.

To read the full text of this Duane Morris Alert, please visit the firm website.

July 26, 2021 by Duane Morris

FDA Issues Final Guidance on Form and Content of Unique Device Identifier Labeling System

On July 7, 2021, the U.S. Food and Drug Administration (FDA) issued a final guidance regarding the form and content of unique device identifier (UDI) labeling. The guidance will assist labelers of medical devices and FDA-accredited issuing agencies (who operate systems for issuing UDIs used by labelers) in meeting the requirements under 21 CFR Part 801, Subpart B, and the Unique Device Identification System Final Rule, 78 FR 58786 (September 24, 2013) (UDI Rule).

To read the full text of this Duane Morris Alert, please visit the firm website.

December 11, 2020 by Duane Morris

FDA’s Additional Draft Guidance on Biosimilarity and Interchangeability to Seek Comments and Suggestions by January 19, 2021

The U.S. Food and Drug Administration (FDA) recently published the draft guidance, Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act, Guidance for Industry. Comments can be submitted to FDA by January 19, 2021.

To read the full text of this Duane Morris Alert, please visit the firm website.

October 6, 2020October 6, 2020 by Duane Morris

FDA Clarifies Evidence Used to Determine “Intended Use” of Medical Products

On September 23, 2020, the U.S. Food and Drug Administration (FDA) published a proposed rule amending the agency’s regulations concerning “intended uses.” While the proposed rule does not signal a fundamental change in FDA’s position that all relevant sources of evidence may be considered, it attempts to make clear what sort of evidence is not on its own sufficient to demonstrate a product’s intended use.

To read the full text of this Duane Morris Alert, please visit the firm website.

September 8, 2020 by Duane Morris

FDA’s New MAPP Shows the Route to Changing Ownership of Generic Drug Applications

The U.S. Food & Drug Administration (FDA) recently issued a new Manual of Policies and Procedures (MAPP), in which it explains the Office of Generic Drugs’ (OGD) policy on facilitating changes to generic drug applications and updating the Orange Book to reflect those changes.

MAPP 5242.1 makes clear that the policies, processes and procedures for changing ownership of an application differ based on whether the change is effected by a simple transfer of ownership or whether it results from a corporate merger or acquisition.

To read the full text of this Duane Morris Alert, please visit the firm website.

August 27, 2020August 27, 2020 by Duane Morris

New Guidance Reveals FDA’s Thinking on Imposition of Civil Monetary Penalties for Violations of Clinical Trial Reporting Requirements

In August 2020, the U.S. Food and Drug Administration issued guidance on the imposition of civil monetary penalties for violations of clinical trial reporting requirements. The new guidance is welcome insight for members of the pharmaceutical, biologics and medical device industries, particularly in light of the race to develop—and convince FDA of the safety and effectiveness of—COVID-19 vaccines, therapeutics and diagnostic tests.

To read the full text of this Duane Morris Alert, please visit the firm website.

August 6, 2020 by Duane Morris

FDA Clarifies Policy on Scope of Review of Multiple-Function Device Products

On July 29, 2020, the U.S. Food & Drug Administration (FDA) issued guidance containing its current thinking, policies and recommendations relating to the manufacturing and marketing of “multiple function” device products—products comprised of at least one FDA-regulated “device” function and at least one “other function”—a function that either does not meet the definition of a “device” under the Federal Food, Drug & Cosmetic Act; that is not subject to premarket approval; or for which the FDA has expressed an intention not to enforce regulatory compliance.

To read the full text of this Duane Morris Alert, please visit the firm website.

July 23, 2020 by Duane Morris

Discussion of Nondrug CBD Products Omitted on New FDA Draft Guidance on Cannabis-Related Clinical Research

On July 21, 2020, the U.S. Food & Drug Administration (FDA) issued draft guidance outlining the agency’s current thinking on the development of drugs containing cannabis or cannabis-derived compounds. The new guidance is disappointing to many in the cannabis industry because it does not provide insight into the FDA’s views on the marketing of nondrug, hemp-derived CBD products.

To read the full text of this Duane Morris Alert, please visit the firm website.

July 9, 2020 by Duane Morris

FDA Issues Guidance on Procedures for Device Establishment Inspections

On June 29, 2020, the U.S. Food & Drug Administration (FDA) issued guidance on how it will implement certain inspection procedures with respect to device establishments—facilities where medical devices are manufactured. The FDA’s guidance contains recommendations about (1) preannouncement notice (and communications prior to an establishment inspection); (2) inspection durations and timeframes; and (3) communications between the establishment’s representative and FDA’s inspector(s) during the inspection process.

To read the full text of this Duane Morris Alert, please visit the firm website.