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Contributors in Regulatory


FDA ordered recall

Life Sciences; Regulatory

"FDA ordered recall" means a recall initiated by a firm in response to an order for such action. Examples would be device recalls ordered under section 518(e), Infant Formula recalls ordered under ...

FDA requested recall

Life Sciences; Regulatory

"FDA requested recall" means a recall initiated by a firm in response to a formal request for such action by the Associate Commissioner for Regulatory Affairs, or the appropriate center director when ...


Life Sciences; Regulatory

The process of obtaining information concerning the other party's case. Methods of discovery are contained in Rule 16 of the Rules of Criminal Procedure, and Rules 26 through 37 of the Rules of Civil ...


Life Sciences; Regulatory

A restraint through formal Court order; to cease a practice or to stop further violation of the Act.

execution of decree

Life Sciences; Regulatory

The carrying out of the court's order e.g., the destruction of goods under seizure by the Marshall in response to a Default Decree of Condemnation.

procedure in admiralty

Life Sciences; Regulatory

Seizure actions taken pursuant to the FD&C Act are (per Section 304(b)) to be in conformity with the procedure in admiralty, which means the Government may initiate confiscation of articles it deems ...


Life Sciences; Regulatory

A "recall" is a firm's removal or correction of a marketed product(s), including its labeling and/or promotional materials, that FDA considers to be in violation of the laws it administers, and ...

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