FDA’s Generic Drug Program: Decreasing Time to Approval and Number of Review Cycles

Chazin, Howard; Woo, Jason; Han, Jing; Grosser, Stella; Luan, Jingyu Julia

doi:10.1007/s43441-019-00016-2

Cited by 6 publications

(4 citation statements)

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“…A few months later, the Aducanumab study was reconducted. After analyzing the clinical data, Aducanumab showed clinical benefits and the FDA accelerated its approval 220 . This decision has brought much controversy.…”

Section: Other Aβ‐related Targets and Substancesmentioning

confidence: 99%

“…After analyzing the clinical data, Aducanumab showed clinical benefits and the FDA accelerated its approval. 220 This decision has brought much controversy. Because there was no clear evidence that the drug slowed clinical cognitive decline in Alzheimer's patients, the FDA expedited its approval, even though a panel of independent experts voted almost unanimously against its approval at the time.…”

Section: Aβ Antibodiesmentioning

confidence: 99%

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Regulation of beta‐amyloid for the treatment of Alzheimer's disease: Research progress of therapeutic strategies and bioactive compounds

Qiu

Liu

et al. 2023

Medicinal Research Reviews

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Alzheimer's disease (AD) is a progressive neurodegenerative disease that is difficult to treat. Extracellular amyloid is the principal pathological criterion for the diagnosis of AD. Amyloid β (Aβ) interacts with various receptor molecules on the plasma membrane and mediates a series of signaling pathways that play a vital role in the occurrence and development of AD. Research on receptors that interact with Aβ is currently ongoing. Overall, there are no effective medications to treat AD. In this review, we first discuss the importance of Aβ in the pathogenesis of AD, then summarize the latest progress of Aβ‐related targets and compounds. Finally, we put forward the challenges and opportunities in the development of effective AD therapies.

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Section: Other Aβ‐related Targets and Substancesmentioning

confidence: 99%

Section: Aβ Antibodiesmentioning

confidence: 99%

Regulation of beta‐amyloid for the treatment of Alzheimer's disease: Research progress of therapeutic strategies and bioactive compounds

Qiu

Liu

et al. 2023

Medicinal Research Reviews

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“…CGT exclusivity was introduced on 18 th August 2017, under section 506H, this established a new procedure for certain drugs, where there is an inadequate generic competition even after the patent expired. For the early development of those drugs, FDA introduced incentives by reducing review cycles and focused on the expedited review and expedited development assistance [2][3]. For claiming this 180-day exclusivity period, the FDA kept a time-bound of 75 days to initiate the first commercial marketing.…”

Section: Introductionmentioning

confidence: 99%

Risk Assessment of Failures in Generic Drug Development and Approval Procedure under Competitive Generic Drug Therapy and Patent Challenge Exclusivities Provided by the United States Food and Drug Administration

Reddy

Ganesh

Babu

et al. 2022

Acta Marisiensis - Seria Medica

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Objective: The United States Food and Drug Administration implemented two exclusivity programs Competitive generic therapy and Patent Challenge exclusivity to develop generic drugs, which provide a 180-day monopoly market for first generic applicants in the United States of America. The aim of the present study is to find the root cause of failures in developing and filing the first generic drugs under these exclusivities and to compare both the exclusivities to find the merits and demerits. Methods: We used descriptive statistics for data analysis of both the exclusivities and Risk assessment was conducted on 14 industries to find the root cause of failures in every stage of the approval procedure by FMECA (Failure mode, Effects and Criticality Analysis). Results: We found 44% of rejections in competitive generic therapy drugs and 30% of rejections in patent challenge exclusivity drugs. The risk analysis conducted on failures found that, in drug selection, 6% of failures are occurred due to rare diseases. In drug development, 9% of failures are occurred due to formulation failures. In pre-approval, 10% of failures are occurred due to secondary patents. In post-approval, 6% of failures are occurred due to product changes after approval. Conclusion: We hope this study can give an idea for small and medium companies in developing countries for the early development of generic drugs for life-threatening diseases.

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“…The prediction of drugs’ BA in vitro can be especially useful in those studies aimed at determining the BE of a generic and a brand-name drug. Indeed, despite the public concern in having access to generic drugs as quickly as possible due to their lower price, the regulatory process for their approval takes time like any other process related to this aspect ( Chazin et al, 2020 ). However, if the chemical equivalence between two chemical entities is relatively easy to establish, it is more complex to prove the BE between two or more formulations, with the same active pharmaceutical ingredients (APIs).…”

Section: Introductionmentioning

confidence: 99%

Combined Methodologies for Determining In Vitro Bioavailability of Drugs and Prediction of In Vivo Bioequivalence From Pharmaceutical Oral Formulations

et al. 2021

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With the aim of developing an in vitro model for the bioavailability (BA) prediction of drugs, we focused on the study of levonorgestrel (LVN) released by 1.5 mg generic and brand-name tablets. The developed method consisted in combining a standard dissolution test with an optimized parallel artificial membrane permeability assay (PAMPA) to gain insights into both drug release and gastrointestinal absorption. Interestingly, the obtained results revealed that the tablet standard dissolution test, combined with an optimized PAMPA, highlighted a significant decrease in the release (15 ± 0.01 μg min−1 vs 30 ± 0.01 μg min−1) and absorption (19 ± 7 × 10–6 ± 7 cm/s Pe vs 41 ± 15 × 10–6 cm/s Pe) profiles of a generic LVN tablet when compared to the brand-name formulation, explaining unbalanced in vivo bioequivalence (BE). By using this new approach, we could determine the actual LVN drug concentration dissolved in the medium, which theoretically can permeate the gastrointestinal (GI) barrier. In fact, insoluble LVN/excipient aggregates were found in the dissolution media giving rise to non-superimposable dissolution profiles between generic and brand-name LVN tablets. Hence, the results obtained by combining the dissolution test and PAMPA method provided important insights confirming that the combined methods can be useful in revealing crucial issues in the prediction of in vivo BE of drugs.

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FDA’s Generic Drug Program: Decreasing Time to Approval and Number of Review Cycles

Cited by 6 publications

References 0 publications

Regulation of beta‐amyloid for the treatment of Alzheimer's disease: Research progress of therapeutic strategies and bioactive compounds

Regulation of beta‐amyloid for the treatment of Alzheimer's disease: Research progress of therapeutic strategies and bioactive compounds

Risk Assessment of Failures in Generic Drug Development and Approval Procedure under Competitive Generic Drug Therapy and Patent Challenge Exclusivities Provided by the United States Food and Drug Administration

Combined Methodologies for Determining In Vitro Bioavailability of Drugs and Prediction of In Vivo Bioequivalence From Pharmaceutical Oral Formulations

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