Pharmaceutical industry news
Fresh coverage across pharma, biotech, medtech, research, approvals, and market-moving developments.
48,663 stories, page 55 of 812
Individualized Human Genome Editing Products: Considerations for BLA Submission and Postapproval Management; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document...
Electronic Submission Template for Investigational Device Exemption (IDE) Applications; Draft Guidance for Sponsors and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidanc...
Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in Food and Drug Administration Fellowship and Traineeship Programs
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public commen...
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Color Additive Certification
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has b...
Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Rapid Response Surveys
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on...
Notice of Approval of Product Under Voucher: Material Threat Medical Countermeasure (MCM) Priority Review Voucher; Bixlenvo (Bictegravir and Lenacapavir)
The Food and Drug Administration (FDA) is announcing the approval of a product redeeming a material...
Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Records; Electronic Signatures
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public commen...






