OR WAIT null SECS
March 18, 2019
The company is recalling 8.4% Sodium Bicarbonate Injection USP, 50 mEq/50 mL (1 mEq/mL) because of glass found in product.
March 15, 2019
The agency published guidance to help with the development of enrichment strategist for clinical investigations of drug and biologic effectiveness.
FDA sent a warning letter to Hospira Healthcare India Pvt. Ltd. for CGMP violations including data integrity issues.
March 13, 2019
Norman (Ned) Sharpless, director of the National Cancer Institute at the National Institutes of Health, will become FDA acting commissioner.
The FDA planned budget features added funds allotted to improved oversight of drugs, biologics, and medical devices.
FDA sent a warning letter to Jubilant Life Sciences after investigators found CGMP violations.
March 12, 2019
Ned Sharpless is tapped to take on acting commissioner role following Gottlieb’s resignation.
A federal court ordered Guardian Pharmacy Services to stop producing compounded drugs.
The agency prioritized the review of the generic angiotensin II receptor blocker to help relieve the shortage of valsartan due to recent recalls.
March 11, 2019
As part of FDA’s ongoing effort to modernize interactions with industry, FDA launched a portal to help with submissions of controlled correspondence via email instead of manual data entry.