The Center for Drug Evaluation and Research (CDER) performs an essential role in public health by ensuring, evaluating, and monitoring the safety and efficacy of drugs before they are sold in the US. Before approving new drug applications, CDER ensures that therapeutic benefits of both prescription and over-the-counter drugs (brand name and generic) provide more health benefits than the potential risks. First passed by Congress in 1992, the Prescription Drug User Fee Act (PDUFA) allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund new drug approvals. The law allowed the FDA to expedite drug approvals, but possibly lowered standards for safety and brought potential conflicts of interest within the FDA and pharmaceutical industry. To examine the conflicts of interest, we conducted a review using the Excerpta Medica database, US National Library of Medicine National Institutes of Health Database (PubMed), Scopus, and Google. Our search yielded Vioxx (rofecoxib) and Exondus-51 (eteplirsen) as examples of consequence when the FDA and pharmaceutical industry are too closely aligned. We further examine how the pharmaceutical industry may indirectly influence the FDA by lobbying to Congress or directly by hiring ex-FDA commissioners.
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http://dx.doi.org/10.1016/j.sapharm.2021.06.009 | DOI Listing |
Curr Microbiol
January 2025
Department of Microbiology and Botany, School of Sciences, J. C. Road, JAIN (Deemed-to-be University), Bangalore, Karnataka, 560027, India.
Endophytic fungi are non-pathogenic organisms that colonise healthy plant tissues asymptomatically. Endophytes derived from medicinal plants are sources for identifying natural products and bioactive compounds with potential uses for industry, medicine, agriculture, and related sectors. In the present study, ethyl acetate crude extracts of four endophytic fungal isolates (CALF1, CALF4, and CASF1) from the medicinal plant Plectranthus amboinicus showed potent antimicrobial activity against the test pathogenic bacteria Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, and Bacillus subtilis using disc diffusion assays.
View Article and Find Full Text PDFProkinetic agents are drugs used to enhance gastrointestinal motility and treat disorders such as Gastroesophageal Reflux Disease (GERD) and gastroparesis. pH-dependent release systems offer targeted drug delivery, allowing prokinetic agents to be released specifically in desired regions of the gastrointestinal tract. This optimizes drug efficacy and minimizes systemic side effects.
View Article and Find Full Text PDFVet Med Sci
January 2025
Department of Industrial Management, Faculty of Humanities, University of Tehran, Kish International Campus, Tehran, Iran.
Background: The poultry industry faces challenges with the high cost and environmental impact of Soybean meal. Feather meal, a byproduct with low digestibility due to its keratin content, is a potential alternative. Recent biotechnological advances, including enzymatic and bacterial hydrolysis, have enhanced its digestibility and nutritional value.
View Article and Find Full Text PDFAdv Mater
January 2025
State Key Laboratory for Manufacturing Systems Engineering, Xi'an Jiaotong University, Xi'an, 710049, P. R. China.
Replicating the structural and functional features of native myocardium, particularly its high-density cellular alignment and efficient electrical connectivity, is essential for engineering functional cardiac tissues. Here, novel electrohydrodynamically printed InterPore microfibrous lattices with anisotropic architectures are introduced to promote high-density cellular alignment and enhanced tissue interconnectivity. The interconnected pores in the microfibrous lattice enable dynamic, cell-mediated remodeling of fibrous hydrogels, resulting in continuous, mechanically stable tissue bundles.
View Article and Find Full Text PDFNanotechnol Sci Appl
January 2025
Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Universitas Padjadjaran, Sumedang, 45363, Indonesia.
Purpose: Improving drug solubility is crucial in formulating poorly water-soluble drugs, especially for oral administration. The incorporation of drugs into mesoporous silica nanoparticles (MSN) is widely used in the pharmaceutical industry to improve physical stability and solubility. Therefore, this study aimed to elucidate the mechanism of poorly water-soluble drugs within MSN, as well as evaluate the impact on the dissolution and physical stability.
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