Regulatory

Regulatory

Industry: Life Sciences

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Regulatory

Mutual recognition agreement (mra)

Life Sciences; Regulatory

A type of memorandum of understanding that provides for the mutual assessment of the comparability of specific FDA programmes or activities with those of a foreign regulatory authority. An MRA is ...

Nolo contendere

Life Sciences; Regulatory

A plea in a criminal case which is essentially the same as a guilty plea. The only difference is that a guilty plea may be used as evidence in a subsequent civil suit against the defendant, but a ...

Judicial district

Life Sciences; Regulatory

Physical parameters, set by Congress, designating the counties under the jurisdiction of a United States District Court.

Magistrate

Life Sciences; Regulatory

A part time or full time court official authorised to try misdemeanour cases without a jury, and to perform certain other duties of the court, such as issuing inspection warrants.

"Market withdrawal" means a firm's removal or correction of a distributed product which involves a minor violation for which FDA would not initiate legal action, or which involves no violation (e.g., ...

Memorandum of understanding (mou)

Life Sciences; Regulatory

This is a formal agreement with a state or local agency. The agreement does not involve a transfer of funds or a transfer of personal or real property (Agreements calling for transfer of funds, or a ...

Subpoena

Life Sciences; Regulatory

A document, issued by the Clerk of the Court which, when delivered to the person named therein, requires him to appear in court, or at a deposition, or before a grand jury.