Search
Search Results
-
-
Avoiding future controversies in the Alzheimer’s disease space through understanding the aducanumab data and FDA review
Key points of disagreement between the aducanumab FDA statistical review, which had primarily negative conclusions, and the clinical review, which...
-
Results of the Interlaboratory Computational Fluid Dynamics Study of the FDA Benchmark Blood Pump
Computational fluid dynamics (CFD) is widely used to simulate blood-contacting medical devices. To be relied upon to inform high-risk decision...
-
Identifying FDA-Approved Drugs that Upregulate Utrophin A as a Therapeutic Strategy for Duchenne Muscular Dystrophy
Duchenne muscular dystrophy (DMD) is a neuromuscular disease caused by mutations and deletions within the DMD gene, which result in a lack of...
-
Cardiac toxicity of brentuximab vedotin: a real-word disproportionality analysis of the FDA Adverse Event Reporting System (FAERS) database
Brentuximab vedotin (BV) has obtained approval for the therapeutic management of classical Hodgkin lymphoma as well as systemic anaplastic large cell...
-
Rare oncology therapeutics: review of clinical pharmacology package of drug approvals (2019–2023) by US FDA, best practices and recommendations
There are many challenges with rare diseases drug development and rare oncology indications are not different. To understand the regulatory landscape...
-
Just-In-Time Education of FDA Regulation and Protection of Intellectual Property for Medical Products: A Course Review After Our First 10 Years
Successful translation of medical devices requires a clear pathway through the business environment, including regulatory obligations and the...
-
Post-progression treatment in cancer randomized trials: a cross-sectional study of trials leading to FDA approval and published trials between 2018 and 2020
BackgroundSuboptimal treatment upon progression may affect overall survival (OS) results in oncology randomized controlled trials (RCTs). We aim to...
-
Medication overdose data analysis: a review of medication error reports in the FDA adverse event reporting system (FAERS)
Backgrounddrug overdose is a common type of medication error, which caused significant patient injuries and economic losses. To determine which drugs...
-
Carboxylic Acid Counterions in FDA-Approved Pharmaceutical Salts
Salification is one of the powerful and widely employed approaches to improve the biopharmaceutical properties of drugs. The FDA’s eighty-year...
-
Structural and biological characterization of pAC65, a macrocyclic peptide that blocks PD-L1 with equivalent potency to the FDA-approved antibodies
Recent advances in immuno-oncology have opened up new and impressive treatment options for cancer. Notwithstanding, overcoming the limitations of the...
-
A disproportionality analysis of adverse events associated to pertuzumab in the FDA Adverse Event Reporting System (FAERS)
BackgroundPertuzumab is widely used for the treatment of HER2 + breast cancer. But its safety in the real world should be continuously monitored. So,...
-
FDA Approaches in Monitoring Drug Quality, Forces Impacting the Drug Quality, and Recent Alternative Strategies to Assess Quality in the US Drug Supply
Since the US Food and Drug Administration (FDA) began monitoring the quality of pharmaceutical manufacturing by enforcing current good manufacturing...
-
-
Efficacy and safety of FDA-approved IDH inhibitors in the treatment of IDH mutated acute myeloid leukemia: a systematic review and meta-analysis
ObjectiveTo systematically evaluate the efficacy and safety of FDA-approved isocitrate dehydrogenase (IDH) inhibitors in the treatment of IDH-mutated...
-
Chimeric antigen receptor T-cell therapy-induced nervous system toxicity: a real-world study based on the FDA Adverse Event Reporting System database
BackgroundNervous system toxicity (NST) is one of the most frequent and dangerous side effects of chimeric antigen receptor T-cell (CAR-T) therapy,...
-
Stratified assessment of an FDA-cleared deep learning algorithm for automated detection and contouring of metastatic brain tumors in stereotactic radiosurgery
PurposeArtificial intelligence-based tools can be leveraged to improve detection and segmentation of brain metastases for stereotactic radiosurgery...
-
Antibiotics and antibiotic-associated diarrhea: a real-world disproportionality study of the FDA adverse event reporting system from 2004 to 2022
BackgroundOur study aimed to assess the risk signals of antibiotic-associated diarrhea (AAD) caused by various antibiotics using real-world data and...
-
A survey of FDA Approved Monoclonal Antibodies and Fc-fusion Proteins for Manufacturing Changes and Comparability Assessment
ObjectiveManufacturing changes occur commonly throughout stages of biologics development and may result in product quality attribute changes. As...
