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Understanding Recent Changes to 505(b)(2) Drugs and Reimbursement

Pharmacy Times

For submission consideration, manufacturers can petition the FDA for ANDA status if the requested change does not require safety or effectiveness studies. It is basically an essential copy, and the pharmaceutical manufacturer has to show bioequivalence to the reference product,” Soefje said. “If

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Responsible antibiotic use: How the industry can lead the way for evidence-backed guidelines

Express Pharma

Antibiotics have long been essential in treating common infections and supporting complex medical interventions like surgeries, cancer chemotherapy, and organ transplants. This creates little financial incentive for pharmaceutical companies to invest in antibiotic research.