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 ...
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 ...
WuXi Biologics (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), announced that its MFG17 drug substance facility located at the Shanghai Fengxian site ...
New draft guidance issued by the US Food and Drug Administration (FDA) is intended to clarify which changes to a pharmaceutical company's manufacturing process must be reported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, ...
Drug Substance manufacturing is a critical component of pharmaceutical production, requiring precise processes, rigorous quality control, and innovative solutions to overcome various challenges. From ...
Voyageur Pharmaceuticals Ltd. (TSX.V: VM) (OTC Pink: VYYRF) ("Voyageur" or the "Company"), a Canadian developer of ...
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 ...
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