FDA clears an Optovue 510(k) for its epithelial thickness mapping software for quantitative measurements of the epithelial and stromal layers of the c...
International Laboratories recalls one lot of pravastatin sodium tablets USP 40 mg packaged in bottles of 30 tablets due to mislabeling.
Federal Register notice: FDA announces the availability of a revised draft guidance on Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage For...
FDA publishes a final guidance on qualification of medical device development tools.
FDA grants a Public Citizen petition asking for labeling changes warning of a drug-drug interaction between Prandin and Plavix, but denies the advocac...
The American Dental Association asks FDA to open a public review process to update five OTC oral health drug monographs.
CDER Office of Strategic Programs director Theresa Mullin says China is reforming its drug approval program as part of its application to join the Int...
Allergan asks FDA to apply multiple restrictions to ANDAs citing its Restasis as the reference-listed drug.