Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...

Designing an efficient platform is crucial for any industrial process. This design process is known as process development, and it has become increasingly important in the pharmaceutical industry at ...

The US Food and Drug Administration (FDA) is out with its fourth draft guidance document under the 2012 Generic Drug User Fee Act, this time explaining the nuances of how generic drug companies can ...

The US Food and Drug Administration (FDA) is allowing more time for industry stakeholders and the public to weigh in on whether new regulations or policies are needed to oversee the generic ...

Continuous process improvement can benefit all aspects of life — from personal New Year’s resolutions to complex drug development. In a world where two-thirds of planned improvement initiatives fail, ...

The potential of using artificial intelligence in drug discovery and development has sparked both excitement and skepticism among scientists, investors and the general public. Researchers have applied ...

Creating a new drug involves significant time, effort, and resources. Many assume drug development is straightforward, with final products approved fairly quickly, but the drug approval timeline can ...

The Food and Drug Administration said it will take steps to speed up the process of developing generic versions of complex biological drugs, in a bid to increase cheaper competition for expensive ...

As drug prices continue to rise and the affordability of medicines for patients remains out of reach, finding new and creative solutions that address affordability, while also rewarding innovation, is ...

President Trump wants pharmaceutical production to return to the United States. A shuttered factory in Louisiana shows how hard that will be for generic medicines. Dr. Reddy’s, an Indian generic ...