Sen. Bill Cassidy says FDA needs to explain why it ignored Congress and expanded its oversight over clinical decision support software.
FDA releases the form FDA-483 with three observations from an inspection at a Eugia Steriles drug manufacturing facility in Andhra Pradesh, India, the third FDA-483 so far issued to company facilities in 2024.
Sen. Bill Cassidy says FDA needs to explain why it ignored Congress and expanded its oversight over clinical decision support software.
FDA releases the form FDA-483 with three observations from an inspection at a Eugia Steriles drug manufacturing facility in Andhra Pradesh, India, the third FDA-483 so far issued to company facilities in 2024.
Eli Lilly plans to file an NDA mid-year for tirzepatide and its use in treating obstructive sleep apnea; the drug is currently marketed as Zepbound for weight management.
CDRH releases reports on its commitment to medical device innovation and safety.
