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FDA says Teva manufacturing delays have led to a shortage of Adderalls immediate-release formulation.[ Price : $8.95]
FDA publishes a final guidance on using comparability protocols for postapproval changes in chemistry, manufacturing, and controls...[ Price : $8.95]
FDA solicits input on a discussion paper raising regulatory issues and questions about direct manufacturing and point-of-care manu...[ Price : $8.95]
The CDER Office of Prescription Drug Promotion says it wants to research how consumers and healthcare providers interpret prescrip...[ Price : $8.95]
FDA says Palm Harbor, FL-based Regener-Eyes is illegally marketing its Regener-Eyes Ophthalmic Solution.[ Price : $8.95]
Federal Register notice: FDA extends the comment period for a draft guidance entitled Laser-Assisted In Situ Keratomileusis (LASIK...[ Price : $8.95]
Federal Register notice: FDA announces a voluntary Total Product Life Cycle Advisory Program pilot that was agreed to between FDA ...[ Price : $8.95]
FDA expands the emergency use authorization for the Moderna and Pfizer/BioNTech bivalent Covid vaccine booster shots to cover chil...