ArticleThe AAPS journal2018
Reflections on FDA Draft Guidance for Products Containing Nanomaterials: Is the Abbreviated New Drug Application (ANDA) a Suitable Pathway for Nanomedicines?
Article in The AAPS journal, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 12 papers.
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.
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.
Who cites it
12 citing papers in PubMed.
- Accelerating the clinical translation of bioengineered anticancer therapeutics.Journal of the National Cancer Center · 2026Article
- Nanodynamic Therapy in Colorectal Cancer: Engineering Precision Immunotherapy and Multimodal Synergy.International journal of nanomedicine · 2026Review
- Beyond borders: engineering organ-targeted immunotherapies to overcome site-specific barriers in cancer.Drug delivery and translational research · 2025Review
- Antimicrobial Nanoparticles Against Superbugs: Mechanistic Insights, Biomedical Applications, and Translational Frontiers.Pharmaceuticals (Basel, Switzerland) · 2025Review
- The Hitchhiker's Guide to Human Therapeutic Nanoparticle Development.Pharmaceutics · 2022Review
- An Elucidative Review to Analytically Sieve the Viability of Nanomedicine Market.Journal of pharmaceutical innovation · 2022Review
- A pragmatic regulatory approach for complex generics through the U.S. FDA 505(j) or 505(b)(2) approval pathways.Annals of the New York Academy of Sciences · 2021Article
- Tackling the challenges of nanomedicines: are we ready?American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists · 2021Review
- Evaluation of the Physicochemical Properties of the Iron Nanoparticle Drug Products: Brand and Generic Sodium Ferric Gluconate.Molecular pharmaceutics · 2021Article
- Nanomedicines and Nanosimilars-Why a Robust Centralised Regulatory Framework Is Essential to Enhance Patient Safety.Frontiers in pharmacology · 2021Article
- The consolidation of nanomedicine.Wiley interdisciplinary reviews. Nanomedicine and nanobiotechnology · 2019Review
- Report of the AAPS Guidance Forum on the FDA Draft Guidance for Industry: "Drug Products, Including Biological Products, that Contain Nanomaterials".The AAPS journal · 2019Article
Corrections and comments
- Erratum issued
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The US Food and Drug Administration (FDA) recently released a draft guidance for industry titled "Drug Products, Including Biological Products, that Contain Nanomaterials." The FDA's attention to the unique safety and efficacy aspects of drugs containing nanomaterials is commendable. This Draft Guidance succeeds in acknowledging the complexity of these products, as well as the challenges associated with approving safe and therapeutically equivalent complex generic versions. However, the challenge posed by the manufacturing process for drugs containing nanomaterials is insufficiently addressed. The critical quality attributes of such products cannot be properly defined, and therefore it is not possible to design informative comparative physicochemical assessments for equivalence. As a consequence, the 505(j) Abbreviated New Drug Application (ANDA) pathway, currently advised as the standard from the FDA, is not suitable for the approval of complex generic products. Drawing from the successful story of biologics, we propose instead a stepwise totality-of-evidence approach, demonstrating similarity and including clinical studies when deemed necessary, as an appropriate alternative to the 505(j) ANDA pathway.
Indexed as
Identifiers
30128758What OpenQuestion holds
Registered trials
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.