Regulatory

Regulatory

Contributors in Regulatory

Regulatory

For FDA regulated products, the amount of liquidated damages assessed by Customs against the lot(s) not redelivered upon Customs demand is, at this printing, triple the amount of the lot value used ...

warning letter

Life Sciences; Regulatory

An informal advisory to a firm communicating the agency's position on a matter but does not commit FDA to taking enforcement action. The agency's policy is that Warning Letters should be issued for ...

for cause inspection

Life Sciences; Regulatory

An inspection that is carried out in response to specific information that raises questions, concerns, or problems associated with an FDA regulated firm or commodity. This information could come to ...

guaranty

Life Sciences; Regulatory

A formal and signed agreement between buyers and sellers in which the latter verifies the goods he sells are not in violation of the FD&C Act when shipped.

health fraud

Life Sciences; Regulatory

The promotion, advertisement, distribution, or sale of articles, intended for human or animal use, that are represented as being effective to diagnose, prevent, cure, treat, or mitigate disease (or ...