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A North Carolina federal judge says the states learned intermediary law applies to medical devices although the law only specifica...[ Price : $8.95]
Zafgen reports to FDA a patient death that occurred in its ongoing Phase 3 study of beloranib in Prader-Willi Syndrome, a rare gen...[ Price : $8.95]
An email campaign by over 100 injured Essure patients deluges CDRH director Jeffrey Shurens in-box, demanding that he revoke Essur...[ Price : $8.95]
Federal Register Notice: FDA reopens the comment period on a notice of public meeting on the reauthorization of the Prescription D...[ Price : $8.95]
FDA says that InvaGen Pharmaceuticals is not following quality control responsibilities and procedures fully.[ Price : $8.95]
CDRH director Jeffrey Shuren tells a conference that FDA wants to develop a new approach to medical device regulation that would p...[ Price : $8.95]
FDA warns Indias Unimark Remedies about significant current good manufacturing practice deviations in its manufacturing of active ...[ Price : $8.95]
FDA says that two recently published final rules will help develop the infrastructure needed for widespread use of unique device i...