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Actions taken by firms to remove problem products
from the market. Recalls may be conducted on a firm's own initiative,
by FDA request, or by FDA order under statutory authority.
Sent from FDA to regulated companies about
regulatory issues.
A weekly report of FDA regulatory activities.
Identify problems with commodities and shippers
and provide guidance to FDA field investigators about import
coverage.
Notices about imported products that FDA
has detained because appear to be out of compliance with the
Federal Food, Drug, and Cosmetic Act.
"Cyberletters" and other information
about actions involving Websites whose offers to sell prescription
drugs online may be illegal.
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Individuals or firms barred from participating
in the drug industry because they have been convicted of crimes
related to FDA's regulation of drugs.
Clinical investigators who have at one time
been disqualified, restricted, or have agreed to certain restrictions
on their conduct in future studies. If an investigator has
been reinstated or restrictions have expired, it is so noted.
Researchers who have had administrative
actions imposed against them by the Office of Research Integrity
(ORI).
Letters issued by FDA when it believes that
a clinical investigator repeatedly or deliberately violated
FDA's regulations governing the proper conduct of clinical
studies involving investigational products or submitted false
information to the sponsor.
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