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PhRMA makes nine recommendations for changes to an FDA draft guidance on the platform technology designation program.[ Price : $8.95]
Ali Pharmaceutical asks FDA to require AbbVie to stop saying it is using Alis Armour Thyroid in a clinical trial since it is using...[ Price : $8.95]
Politico explores the many ideas people have for improving FDFA regulation of artificial intelligence.[ Price : $8.95]
CDER reports on research into how healthcare providers view and use Boxed Warnings when making treatment decisions for their patie...[ Price : $8.95]
Denali Therapeutics plans to submit a BLA early next year that will seek accelerated approval for DNL310 (tividenofusp alfa) and i...[ Price : $8.95]
FDA releases a guidance entitled Bioresearch Monitoring Technical Conformance Guide Technical Specifications Document that provid...[ Price : $8.95]
FDA releases the form FDA-483 with five observations from an inspection at the Otsuka Pharmaceutical second factory in Tokushima, ...[ Price : $8.95]
FDA clears an Embecta 510(k) for its Disposable Patch Pump for Insulin Delivery, intended for use by adults who require insulin to...