Life Sciences

Life Sciences

The life sciences encompass all the fields of science concerned with the study of living organisms, and not ecluding other subjects such as bioethics.

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Life Sciences > 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 ...

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 ...

discovery

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 ...

enjoin

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 ...

recall

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 ...