What is coastal subsidence?

Major technological advances have made measurements of coastal subsidence more sophisticated, but these advances have not always been matched by a thorough examination of what is actually being measured. Here we draw attention to the widespread confusion about key concepts in the coastal subsidence literature, much of which revolves around the interplay between sediment accretion, vertical land motion and surface-elevation change. We attempt to reconcile this by drawing on well-established concepts from the tectonics community.

The Food and Drug Administration's (FDA's) Drug Safety Surveillance During the COVID-19 Pandemic.

Introduction: On 4 February, 2020, the Secretary of the Department of Health and Human Services declared a public health emergency related to coronavirus disease 2019 (COVID-19), and on 27 March, 2020 declared circumstances existed to justify the authorization of the emergency use of drug and biological products (hereafter, "drugs") for COVID-19. At the outset of the pandemic with uncertainty relating to the virus, many drugs were being used to treat or prevent COVID-19, resulting in the US Food and Drug Administration's (FDA's) need to initiate heightened surveillance across these drugs.

Objective: We aimed to describe the FDA's approach to monitoring the safety of drugs to treat or prevent COVID-19 across multiple data sources and the subsequent actions taken by the FDA to protect public health.

Real-world evidence to support regulatory decision-making for medicines: Considerations for external control arms.

Randomized clinical trials (RCTs) are the gold standard in producing clinical evidence of efficacy and safety of medical interventions. More recently, a new paradigm is emerging-specifically within the context of preauthorization regulatory decision-making-for some novel uses of real-world evidence (RWE) from a variety of real-world data (RWD) sources to answer certain clinical questions. Traditionally reserved for rare diseases and other special circumstances, external controls (eg, historical controls) are recognized as a possible type of control arm for single-arm trials.

Understanding utilization patterns of biologics and biosimilars in the United States to support postmarketing studies of safety and effectiveness.

Purpose: To describe utilization of filgrastim and infliximab, the first two products with biosimilars approved in the United States.

Methods: We identified use of filgrastim (reference, tbo-filgrastim, and filgrastim-sndz) and infliximab (reference, infliximab-dyyb, and infliximab-abda) in the Sentinel Distributed Database using Healthcare Common Procedure Coding System (HCPCS) codes and National Drug Codes (NDCs) from January 2015 to August 2018. We calculated the proportion of use by code type and assessed uptake over time.

Safety and antibody response, including antibody persistence for 5 years, after primary vaccination or revaccination with pneumococcal polysaccharide vaccine in middle-aged and older adults.

Background: This study assessed antibody levels for 5 years after primary vaccination or revaccination with 23-valent pneumococcal polysaccharide vaccine (PN23).

Methods: Subjects were enrolled into 4 study groups by age (50-64 or > or = 65 years) and prior vaccination status (no prior vaccination or 1 vaccination 3-5 years previously). Blood was obtained on day 0 (before primary vaccination or revaccination), day 30, day 60, and annually during years 2-5.

Pericardial effusion coincident with sirolimus therapy: a review of Wyeth's safety database.

Sirolimus is an immunosuppressive agent approved for prophylaxis of acute rejection in renal transplant patients aged 13 years or older. A retrospective review of pericardial effusion coincident with sirolimus therapy was conducted from key clinical trials and spontaneous reporting sources. A significantly higher rate of pericardial effusion occurred with sirolimus versus azathioprine treatment in a cardiac transplantation trial (28.

T cell-specific expression of the murine CD3delta promoter.

T cell-specific expression of human and mouse CD3delta is known to be governed by an enhancer element immediately downstream from the gene. Here we demonstrate by transgenic and in vitro studies that the murine CD3delta (mCD3delta) promoter prefers to be expressed in cells of the T lineage. Deletion analyses of a promoter segment (-401/+48 bp) followed by transient transfections indicate that upstream elements between -149 and -112 bp contribute to full expression of the gene.