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FDA publishes a draft guidance on recommended documentation for premarket submissions of medical device software functions.[ Price : $8.95]
FDA says it is evaluating a DC federal court ruling remanding to the agency its memorandum of understanding with states on the int...[ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Novartis Adakveo (crizanliz...[ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Sanofis Dengvaxia (dengue t...[ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Galdermas Aklief (trifarote...[ Price : $8.95]
FDA approves Insightecs Exablate Neuro for a third indication.[ Price : $8.95]
FDA grants breakthrough device designation for TecTraums Pro2cool system to improve concussion outcomes.[ Price : $8.95]
A BMJ investigation says a Ventavia Research Group whistleblower informed FDA about multiple irregularities in the companys work t...