FDA Outlines New Communication Process for Generic Drug Companies The US Food and Drug Administration (FDA) is out with its fourth draft guidance document under the 2012 Generic Drug User Fee Act, ...

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 ...

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 ...

The US Food and Drug Administration (FDA) approved or tentatively approved 776 Abbreviated New Drug Applications (ANDAs) for generic drugs in 2021, continuing a steady decline in generic approvals in ...

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 ...

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 ...

EpiPen will face competition in a generic version of the auto-injector marketed by Teva Pharmaceuticals and approved by the U.S. Food and Drug Administration on Thursday. The FDA previously approved ...

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 ...