FDA says it will receive until 10/30 joint applications from drug manufacturers and qualified research institutions to be one of 8-10 applicants chosen to participate in the new Expedited IND Pilot program.
FDA warns Bausch and Lomb about CGMP violations at its Tampa, FL, drug manufacturing facility.
FDA says it will receive until 10/30 joint applications from drug manufacturers and qualified research institutions to be one of 8-10 applicants chosen to participate in the new Expedited IND Pilot program.
FDA warns Bausch and Lomb about CGMP violations at its Tampa, FL, drug manufacturing facility.
FDA approves a Scholar Rock BLA for Isembyld (apitegromab-mstn) injection to treat spinal muscular atrophy.
FDA seeks input on whether traditional statistical standards should be modified for rare disease clinical investigations, including when the agency might accept different significance thresholds, external controls and other approaches intended to address the challenges of studying very small patient populations.
