Fresh from the biotech pipeline: FDA turmoil overshadows 2025 approvals

Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...

Segregation in fresh concrete is a phenomenon where the components of the concrete mix separate, leading to uneven distribution and compromised structural integrity. This separation typically occurs when concrete is subjected to excessive horizontal movement within forms, or when it is dropped from considerable heights or forced through narrow, winding paths. As a result, heavier coarse aggregate particles settle at the bottom, while lighter, finer materials such as cement and water rise to the...

Bleeding in fresh concrete occurs when water from the mix rises to the surface. This happens because the mix's solid components fail to retain all the water as they settle, leading to separation where water collects at the top. The severity of bleeding can be measured by assessing the total settlement or by noting the decrease in height per unit height of concrete.
Bleeding can cause several issues in the concrete structure. Sometimes, the rising water gets trapped beneath large aggregate...

According to obedience research, we may harm others under the forceful pressures of an authority figure (Milgram, 1974). How about if the inappropriate orders were delivered with less force? The increasing interdependence between nurses and physicians compelled Hofling and his colleagues to explore nurses’ reactions to a potentially harmful medical request made by the perceived authority figure, the doctor (Hofling, Brotzman, Dalrymple, Graves, & Pierce, 1966). In this situation,...

Today, scientists agree that good research is ethical in nature and is guided by a basic respect for human dignity and safety. However, this has not always been the case. Modern researchers must demonstrate that the research they perform is ethically sound.