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Newer Approach Could Help Biosimilar Development: FDA
FDA researchers say there have been global efforts to streamline biosimilar development of therapeutic proteins (TPs) by reducing reliance on comparative efficacy studies and moving instead toward a comparative analytic assessment plus pharmacokinetics approach. Writing in the open-source Clinical Pharmacology & Therapeutics, the researchers say the new approach is
FDA Seeks Solutions to Data Barriers in Real-World Evidence Submissions
CDER and CBER are seeking industry input on how to overcome legal, privacy and technical barriers that prevent them from accessing patient-level data used to support product applications containing real-world evidence (RWE). In a request for information (RFI) scheduled for publication in the 11/12 Federal Register, FDA
Ex-HHS Aide Says Overton Pressured Makary Over Vaccine Approval
Former senior HHS adviser Calley Means has accused FDA commissioner nominee Heidi Overton of pressuring former commissioner Marty Makary to approve Moderna's mRNA influenza vaccine despite his scientific objections, alleging that she conditioned assistance on other policy matters on his willingness to approve the product. Means resigned 10/
Novocure Gets Rejection Letter on Lung Cancer Device
FDA has issued Novocure a Not Approvable Letter for its PMA for Optune Mya for treating adult patients with brain metastases from non-small cell lung cancer following stereotactic radiation. The said the agency determined that uncertainty around the degree of clinical benefit provided by Optune Mya prevented approval, according