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FDA releases the form FDA-483 with 11 observations from an inspection at Indias Eugia Pharma Specialties sterile drug manufacturin...[ Price : $8.95]
FDA publishes a guidance with recommendations for how sponsors of animal drugs may facilitate changes to the approved conditions o...[ Price : $8.95]
Public Citizen petitions HHS to use existing law to eliminate patent barriers that prevent the entry of generic forms of Novo Nord...[ Price : $8.95]
Hyman, Phelps & McNamara attorney Peter Dickos reviews a Florida federal court decision that said FDA Warning Letters sent to Hybr...[ Price : $8.95]
CBER director Vinay Prasad overrules the Centers career reviewers in deciding to issue Moderna a refusal-to-file letter for its BL...[ Price : $8.95]
Politico says some GOP senators expressed frustration with FDA over a lack of apparent progress on its supposed safety review of t...[ Price : $8.95]
A detailed Reuters report looks at instances of surgical adverse events that may be related to artificial technology-enhanced medi...[ Price : $8.95]
FDA approves Novocures Optune Pax for use in combination with gemcitabine and nab-paclitaxel for adults with locally advanced panc...