Development of Drug-Device Combination Products and Generic Substitution in the United States.

Ila Srivastava, YoonJung Lee, Katharine B Feibus, Elizabeth R Bielski, Lolita Sterrett, Danielle Harris, Markham C Luke

Abstract readReview

In one paragraph

Review in Innovations in pharmacy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it

0cells of the map it votes in

0citing papers in PubMed

–field-weighted citation impact

1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Ila SrivastavaCenter for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993.ORCID https://orcid.org/0000-0001-6692-6680

YoonJung LeeCenter for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993.ORCID https://orcid.org/0000-0002-8542-8991

Katharine B FeibusCenter for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993.

Elizabeth R BielskiCenter for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993.ORCID https://orcid.org/0000-0003-0838-6705

Lolita SterrettCenter for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993.ORCID https://orcid.org/0009-0005-4461-2978

Danielle HarrisCenter for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993.

Markham C LukeCenter for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Generic drug products approved and marketed in the United States include a variety of drug classes and dosage forms along with drug-device combination products (DDCPs). Development of DDCPs can pose scientific, regulatory, and legal challenges, and the Food and Drug Administration (FDA) has prioritized efforts to work with industry to improve scientific methodologies and application quality in an effort to provide quicker access to high-quality generic DDCPs. Once these products become available in the market, the roles of pharmacists and other healthcare providers (HCPs) become crucial. When prescribing, HCPs should provide risk/benefit counseling and, to prevent medication errors, teach patients about the proper use of these products. This review provides a comprehensive overview of the regulatory and developmental processes of generic DDCPs to help pharmacists and other healthcare professionals engage more effectively with patients.

Indexed as

complex productdrug-device combination productgenericgeneric substitutionregulatorytherapeuticequivalence

Identifiers

PMID42253385

DOI10.24926/iip.v16i2.6461

PMCPMC13233167

What OpenQuestion holds

Textmetadata

LicenceCC BY-NC

Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.