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© 2023 MJH Life Sciences and BioPharm International. All rights reserved.
© 2023 MJH Life Sciences™ and BioPharm International. All rights reserved.
A Congressional probe of FDA’s approval of Alzheimer’s treatment targets the agency’s interactions with drug manufacturers.
Cautiously setting aside pandemic practices, pharma workers appear ready for flux, change, evolution, and expanding molecular diversity.
Manufacturing biopharmaceuticals in an aging facility may create quality issues such as equipment breakdown and contamination risks.
March 16, 2023
27 drugs within Medicare will face penalties for having their prices raised faster than the rate of inflation.
March 15, 2023
Technological advances hold promise for mitigating human error in the pharmaceutical industry, especially in quality assurance/quality control, by reducing the incidence of, and risk associated with, mistakes.
A phase-appropriate analytical development strategy is crucial, especially for complex (formulated) drug substances.
This article focuses on drawing parallels between ICH Q14/Q2(R2), United States Pharmacopeia (USP) , and International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025:2017.
This article provides an overview of validation concept principles evolution to a life cycle risk-based approach with focus on compendial perspectives.
March 14, 2023
FDA is seeking $7.2 billion to enhance food safety and advance medical product availability.
March 10, 2023
Even after an FDA advisory panel voted 14–1 in October 2022 to remove the drug, Makena manufacturer Covis Pharma continued to press for some continued access to the therapy.
March 09, 2023
Congressional leaders are investigating how pharmacy benefit managers determine health plan coverage and charges for medicines.
March 06, 2023
Any patients who have received the identified lots or have any questions regarding the recall should contact their pharmacy or immediately contact a health provider in terms of medical advice.
March 01, 2023
Advances in vaccine development are creating partnerships and stimulating clinical trials to develop new mRNA applications.