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Rep. Andy Harris calls for an investigation to determine whether an FDA cozy relationship with the drug industry led to a 10-year ...[ Price : $8.95]
Arcutis asks FDA to restrict approvals of any ANDA citing its Zoryve psoriasis cream as the reference-listed drug.[ Price : $8.95]
FDA opens its eSTAR electronic submission template for voluntary use for certain PMA submissions.[ Price : $8.95]
CBER director Peter Marks outlines his Centers plans to speed gene therapy development, such as through FDA-encouraged harmonizati...[ Price : $8.95]
FDA accepts for priority review a Bristol Myers Squibb (BMS) supplemental BLA for Opdivo (nivolumab) for combination use with cisp...[ Price : $8.95]
Federal Register notice: FDA amends its animal drug regulations to reflect application-related actions during July, August, and Se...[ Price : $8.95]
Three medical device industry stakeholders raise multiple legal and regulatory concerns with an FDA draft guidance on choosing an ...[ Price : $8.95]
FDA warns Chicago, IL-based Belmont Eyecare it is illegally marketing six types of eye drops that are unapproved new drugs.