FDA issues a safety alert on a Class 1 recall of Beckman Coulters DxH 800, DxH 600 and DxH 900 hematology analyzers due to inaccurate blood platelet c...
A House Agriculture subcommittee votes to advance a fiscal year 2020 spending bill that would increase FDAs budget authority by 6% ($184 million) over...
FDA releases the FDA-483 with three observations following an inspection at Indias Lupin, Ltd., drug manufacturing firm.
FDA clears a Roche 510(k) for the cobas TV/MG test for use on the cobas 6800/8800 Systems for detecting Trichomonas vaginalis and Mycoplasma genitaliu...
Two drug industry stakeholders comment on an FDA draft guidance on bioavailability studies submitted in NDAs and INDs.
The Justice Department asks a federal court for an injunction to stop Confidence USA from selling dietary supplements that dont meet cGMP requirements...
The governments Spring 2019 rule list includes 80 proposed rule stage and final rule stage items from FDA.
FDA posts a draft guidance on Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Consideratio...