Operating under the FDA's 503B pathway, the Apex facility will prioritize the production of generic shortage-listed ...

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 ...

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 ...

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 post ProPublica Publishes Unreleased Data on the Origins of Generic Prescription Drugs appeared first on ProPublica.

NEW DELHI — In the global pursuit of greater pharmaceutical accessibility, Indian generic drugs have gained popularity for their affordability and broad reach, while also facing persistent challenges ...

Guidance development and publication from the Food and Drug Administration (FDA) has long been considered an essential element of medical product development, approval, and regulation. While temporary ...