M11 Template: Clinical Electronic Structured Harmonised Protocol (CeSHarP)

FDA held a meeting with several states to discuss the section 804 importation program (SIP), which allows states and Indian tribes to import certain prescription drugs from Canada to significantly reduce the cost of these drugs to the American consumer.

Unapproved New Drugs/Misbranded

Sponsor/Investigator

MicroMyst Applicators are being recalled due to potential non-sterile product., but these devices may not have been properly sterilized.

The following are the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted in response to a Written Request issued under the BPCA and pediatric assessments conducted under PREA.