A new guidance document issued by the US Food and Drug Administration's (FDA) drug and biologics review divisions explains how the agency handles Prior Approval Supplements (PAS) under its generic ...

New draft guidance issued by the US Food and Drug Administration (FDA) is intended to clarify which changes to a pharmaceutical company's manufacturing process must be reported to federal regulators, ...

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 ...

Drug Substance manufacturing is a critical component of pharmaceutical production, requiring precise processes, rigorous quality control, and innovative solutions to overcome various challenges. From ...

Pharmaceutical manufacturing steps are often isolated in space and time. The synthesis, isolation and purification of the drug substance (DS) and the formulation of the drug product (DP) may be ...

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 ...

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 ...

Pharmacy benefit managers received substantial attention during 2024. Congress and regulating agencies including the FTC and HHS scrutinized PBM business practices and related profits. As a new ...

While much of the conversation around the Trump administration’s potential pharmaceutical import tariffs has leaned heavily toward branded drugmakers, generic medicines and the companies that ...

President Trump wants to bring pharmaceutical manufacturing back to the United States. Experts warn that tariffs could result in shortages and higher prices for generic drugs. By Rebecca Robbins The ...

It could be years before a cell therapy from Nkarta reaches autoimmune disease patients in the market, but CEO Paul Hastings still thinks about the impact of pharmaceutical tariffs here and now. With ...