Federal Register notice: FDA makes available a draft guidance entitled Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Med...
Elekta Instrument recalls its Disposable Biopsy Needles from one batch (837838839) because they possibly contain some microscopic stainless steel debr...
FDA approves Pfizers Beqvez (fidanacogene elaparvovec-dzkt), a gene therapy for treating adults with moderate to severe hemophilia B.
FDA grants fast track designation to Compass CTX-009 that is in a Phase 2 study with paclitaxel to treat some biliary tract tumors.
FDA publishes a draft guidance to help sponsors expand eligibility for cancer drug clinical trials in terms of washout periods and concomitant medicat...
Federal Register notice: FDA announces that OMB has approved an information collection entitled Electronic Records: Electronic Signatures.
Federal Register notice: FDA makes available a revised draft guidance entitled Promotional Labeling and Advertising Considerations for Prescription Bi...
Three SheppardMullin attorneys say that manufacturers of tests labeled for research use only should review customer lists and promotional claims to be...
