Joanne S. Eglovitch
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Latest From Joanne S. Eglovitch
This year’s 89 warning letters so far hit API testing for nitrosamines, aseptic facility design, contaminated water, API traceability and more.
After discovering one firm suppressed over 4,000 compounded-hormone adverse event reports, agency leans on compounders and outsourcers to improve reporting.
New messaging standard from GS1 would enable industry to sell most returned drugs after November DSCSA deadline without running afoul of the FDA.
FDA proposal would allow traditional compounding from five drug substances based on medical need, but not from another 26.
The public-private partnership has $5.5m for grants to develop continuous manufacturing methods, cell/gene therapy platforms and other biopharmaceutical manufacturing innovations.
Expected flurry of FDA proposals against 503B compounding from bulk drug substances follows vasopressin court ruling.