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Shoolin Pharma Insanitary Conditions, CGMP Issues

[ Price : $8.95]

FDA warns Indias Shoolin Pharma Chem that it is producing active pharmaceutical ingredients in insanitary conditions and with sign...

Boxed Warning for Injectafer on Low Phosphate Levels

[ Price : $8.95]

FDA orders a Boxed Warning for American Regents Injectafer (ferric carboxymaltose injection) over the risk of symptomatic hypophos...

uniQure Files BLA for Huntingtons Gene Therapy

[ Price : $8.95]

Following a course reversal by FDA, uniQure files a BLA seeking accelerated approval of ifezuntirgene inilparvovec (AMT-130), an i...

Early Alert: Convenience Kit Issue from AVID Medical

[ 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...

Pediatric Research Policy and Procedure

[ Price : $8.95]

CBER publishes a Standard Operating Policy and Procedure resource on complying with provisions of the Pediatric Research Equity Ac...

Stakeholder Suggestions to Improve Gene Therapy Draft Guidance

[ Price : $8.95]

Four stakeholders recommend ways FDA can improve a draft guidance on leveraging prior knowledge in developing some human gene ther...

Cancer White Paper on Dosage Optimization

[ Price : $8.95]

A Friends of Cancer Research white paper recommends a new approach to support administered activity escalation and dosage optimiza...

CGMP Violations at Fresenius Ogden, UT, Plant

[ Price : $8.95]

FDA warns Fresenius Medical Care North America about CGMP violations at its Ogden, UT, drug manufacturing facility.

Two Guidances on Dental Composites and Curing Lights

[ Price : $8.95]

FDA posts two guidance documents on dental composite resins and curing lights.

CGMP Violations Seen at Indias Reliance Life Sciences

[ Price : $8.95]

FDA warns Indias Reliance Life Sciences about significant CGMP violations in its production of finished drugs.