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A just-posted citizen petition from Luitpold Pharmaceuticals requests that FDA require that any NDA for injectable iron for treati...[ Price : $8.95]
The U.S. Senate passes and sends on to the President legislation on drug compounding safety which included track and trace drug su...[ Price : $8.95]
Federal Register Notice: FDA seeks comments on information collection in the guidance on special protocol assessment.[ Price : $8.95]
Sanofi decides to cancel the development of its investigational JAK2 inhibitor SAR302503 (fedratinib) due to safety concerns.[ Price : $8.95]
FDA releases updated FDA Form-356h and FDA Form-2253, as well as accompanying instructions.[ Price : $8.95]
FDA revises a draft guidance to clarify requirements for product name placement, size, prominence, and frequency in promotional la...[ Price : $8.95]
FDA denies clearance of a Ventripoint Diagnostics 510(k) for its Ventripoint Medical Systems use in pulmonary aterial hypertension...[ Price : $8.95]
CDER director Janet Woodcock tells a congressional hearing that the Office of Generic Drugs has shut down most communications with...