The US Food and Drug Administration (FDA) has published a manual of policies and procedures (MAPP) outlining how the Office of Generic Drugs (OGD) will classify which new drugs and drug-device ...

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 ...

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 ...

Delve into the hidden innovation system of drug repurposing. When patents expire and commercial value fades, a new wave of ...

Defining the steps involved in a successful technology transfer process would benefit biopharma, say the researchers behind a “generic” blueprint intended to help drug makers move more easily from ...

This Brush Up is sponsored by MilliporeSigma. Learn more about therapeutic synthesis pathways. Drug development is a process that spans many years, from the initial phase of identifying potential drug ...

India is considering stronger regulatory data protection for new medicines. The country's generic pharmaceutical industry has ...

Federal regulators have agreed to review a Swiss pharmaceutical company's applications for two cheaper generic versions of ...

Generic drugs are cheaper copies of brand drugs, offering significant savings to patients. Once a brand-name drug's patent expires, competitors can apply to make generic versions. Generic ...

FDA accepts two applications for generic weight loss drugs amid international competition as well as issues of patents and ...