Manufacturers count on faster product approvals under Cures Act

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,...

The hydration of cement takes place within the water-filled capillary pores. However, environmental elements can disrupt this process by evaporating water from the concrete surfaces. Sealed concrete with a water-cement ratio below 0.5 experiences self-desiccation, leading to water loss. The water loss in concrete is mitigated by curing. This technique involves keeping the concrete saturated to maintain the necessary temperature and moisture conditions, to optimally fill the spaces in the cement...

Concrete members with a small surface-to-volume ratio are cured by oiling and moistening the forms before casting the concrete member. These forms can be left in place for a prolonged period to prevent moisture loss, and can be wetted if made of a material suitable for wetting. If the forms are removed early, the concrete member is moistened and covered with polythene sheets to maintain moisture. For large horizontal concrete surfaces exposed to dry weather, a temporary covering is suspended...

Accelerating concrete curing is achieved by applying heat and additional moisture. This process accelerates the hydration of the cement, resulting in an earlier strength gain in the concrete. Steam curing is a method wherein the concrete products are either transported through a chamber on a conveyor belt or encased in plastic, allowing steam at atmospheric pressure to circulate freely around them. This process begins with a phase of moist curing that typically lasts between 3 to 5 hours, after...

Steel manufacturing is a multi-stage process that begins by smelting iron ore into cast iron in a blast furnace. This initial stage involves layering iron ore with coke, a type of fuel, and crushed limestone within the furnace. The coke is ignited with a high volume of air, leading to the creation of carbon monoxide, which acts to reduce the iron ore to pure iron.
During this smelting process, limestone plays a crucial role by forming slag. Slag captures impurities within the molten iron, such...

The process of manufacturing concrete masonry units begins by mixing stiff concrete composed of Portland cement, aggregates, and water. This mixture is then poured into metal molds. To ensure the concrete settles uniformly and to avoid separation of its components, the mixture in the molds is subjected to vibration. Shortly after, the still-wet blocks are removed from the molds and placed on racks.
These wet blocks are then transported for curing, which can occur in one of two environments: a...