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FDA warns Indias Shoolin Pharma Chem that it is producing active pharmaceutical ingredients in insanitary conditions and with sign...[ Price : $8.95]
FDA orders a Boxed Warning for American Regents Injectafer (ferric carboxymaltose injection) over the risk of symptomatic hypophos...[ Price : $8.95]
Following a course reversal by FDA, uniQure files a BLA seeking accelerated approval of ifezuntirgene inilparvovec (AMT-130), an i...[ Price : $8.95]
CDRH issues an alert on AVID Medical convenience kits based on a letter the company sent to customers recommending that certain ki...[ Price : $8.95]
CBER publishes a Standard Operating Policy and Procedure resource on complying with provisions of the Pediatric Research Equity Ac...[ Price : $8.95]
Four stakeholders recommend ways FDA can improve a draft guidance on leveraging prior knowledge in developing some human gene ther...[ Price : $8.95]
A Friends of Cancer Research white paper recommends a new approach to support administered activity escalation and dosage optimiza...[ Price : $8.95]
FDA warns Fresenius Medical Care North America about CGMP violations at its Ogden, UT, drug manufacturing facility.