[ Price : $8.95]
Federal Register Notice: FDA releases a guidance, Data Elements for Submission of Veterinary Adverse Event Reports to the Center f...[ Price : $8.95]
CDER medical reviewers say Gilead's sofosbuvir appears to be acceptably safe and effective as a hepatitis C treatment in combinati...[ Price : $8.95]
Federal Register Notice: FDA releases a guidance, Q4B Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH Regi...[ Price : $8.95]
FDAs Florida District Office warns Capillus about Quality System, Medical Device Reporting, and other violations in its manufactur...[ Price : $8.95]
Viiv Healthcare says it is submitting an NDA for a combination HIV-1 drug based on its Tivicay and two other antiretrovirals.[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Capillus, Dolphin Intertrade, Omid Nassam, R82 A/S. Dimitri Sirakoff, USP Labs, ...[ Price : $8.95]
FDA approves a Lupin supplemental NDA for Antara (fenofibrate) capsules in 30 mg and 90 mg strengths, indicated for treating patie...[ Price : $8.95]
Cubist Pharmaceuticals submits an NDA for its investigational antibiotic tedizolid phosphate, indicated for treating acute bacteri...