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FDA releases an FDA-483 with 10 observations from an inspection at a Hospira sterile drug manufacturing facility.[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance on demonstrating bioequivalence for soluble powder drug products.[ Price : $8.95]
Medical Action Industries recalls its Medical Convenience Kits that include the BD/Carefusion Chloraprep 3mL applicator, which was...[ Price : $8.95]
Federal Register notice: FDA releases a draft guidance on adjusting for covariates in drug/biologic clinical trials.[ Price : $8.95]
FDA issues a final guidance on regulatory, quality, nonclinical, and clinical considerations for bispecific antibody development p...[ Price : $8.95]
CDER director Patrizia Cavazzoni says the Center will apply an intense focus to encourage the pharmaceutical industry to achieve q...[ Price : $8.95]
Federal Register notice: FDA announces a 6/10 Vaccines and Related Biological Products Advisory Committee meeting to discuss Covid...[ Price : $8.95]
Federal Register notice: FDA announces a 7/15 Cardiovascular and Renal Drugs Advisory Committee meeting to review FibroGen anemia ...