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A Clinical Trial Vanguard column demonstrates how synthetic biology is outstripping FDAs regulatory framework under the Supreme Co...[ Price : $8.95]
FDA releases the form FDA-483 with five repeat observations from an inspection at Houston, TX-based Revive Rx Pharmacy.[ Price : $8.95]
Researchers describe FDA and congressional actions that will improve the ability of the new plausible mechanism pathway to lead to...[ Price : $8.95]
Gilead calls on FDA to rescind its decision to file a Cipla 505(b)(2) NDA for an apparent duplicate of Gileads Descovy.[ Price : $8.95]
FDA issues a Warning Letter to New Life Pharma citing serious manufacturing and regulatory violations tied to the companys product...[ Price : $8.95]
FDA extends by three months its review of a Sanofi BLA for a subcutaneous formulation of Sarclisa (isatuximab-irfc) for use in com...[ Price : $8.95]
FDA releases the form FDA-483 issued following an inspection at the Vet4U drug distribution facility in Clay, NY.[ Price : $8.95]
An unidentified major drug company calls on FDA to establish a process for redacting complete response letters for unapproved appl...