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Regulatory
Industry: Life Sciences
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Regulatory
notice of detention and hearing (form fda-718)
Life Sciences; Regulatory
Issued by FDA to the importer when articles offered for entry into the U.S. appear to be in violation of the law. It affords the importer an opportunity (10 working days) to offer testimony ...
notice of refusal of admission (nora) (form fda-772)
Life Sciences; Regulatory
Form issued to importer indicating that an entry of merchandise appears violative and that it is refused admission into the U.S. This occurs after the importer has been provided an opportunity to ...
permanent injunction
Life Sciences; Regulatory
A Decree of Permanent Injunction may be entered at any time after the complaint is filed, either following a hearing or as a result of a negotiated settlement. Defendants in an injunction proceeding ...
preliminary injunction
Life Sciences; Regulatory
Whether or not a TRO has been obtained, a Motion for Preliminary Injunction is subject to a full hearing in which (1) evidence by affidavit, and/or (2) testimony of witnesses is presented, depending ...
prior notice
Life Sciences; Regulatory
The FDA policy of notifying an individual or firm of a violation of the Federal FD&C Act, or other acts, when voluntary correction is an appropriate initial response to the violation. This policy is ...
adjudicate (adjudication)
Life Sciences; Regulatory
To make a final judgment in a lawsuit. The judgment of the court.
admonition
Life Sciences; Regulatory
A reprimand from a judge to a person accused, on being discharged, warning of the consequences of his conduct and should he be guilty of same fault, he will be punished with greater severity.