A required preapproval inspection delays Sol-Gel Technologies NDA review for Epsolay (benzoyl peroxide) 5% topical cream for treating rosacea inflamma...
FDA publishes a draft guidance on nonclinical information supporting an IND for some antisense oligonucleotides.
Attorney Sara Koblitz explains the importance of a recent 5th Circuit Court of Appeals decision in an FTC pay-for-delay case.
FDA grants Medtronic a breakthrough device designation for the Emprint ablation catheter kit, which is intended to be used in conjunction with the Emp...
FDA says it is concluding the Quality in 510(k) Review pilot program as of 5/30 and recommending that submitters make use of eSTAR instead.
Saniona says responding to an FDA request for Tesomet manufacturing information will delay the start of a Phase 2b trial.
FDA brings Erica Jefferson back to the agency as associate commissioner for external affairs.
FDA releases its latest batch of Warning Letters that include American Specialty Pharmacy and Exela Pharma Sciences.