FDA approves alectinib as adjuvant treatment for ALK-positive non-small cell lung cancer On April 18, 2024, the Food and Drug Administration approved alectinib (Alecensa, Genentech, Inc.) […]
To encourage innovation and competition in the market for biological products and facilitate the development of biosimilars and interchangeable biosimilars, FDA has developed the Biosimilars Action […]
Office of Communications10001 New Hampshire AveHillandale Building, 4th FlSilver Spring, MD 20993 Toll Free (855) 543-3784 (301) 796-3400 Hours Available CDER Division of Drug Information
FDA classifies inspections based on a company’s state of compliance as acceptable or unacceptable with respect to CGMP requirements: No action indicated (NAI) classification indicates a facility […]
Patients often receive several types of informational documents with their prescription medication. These documents are intended to help patients take their drugs safely and effectively, help […]
FDA is notifying consumers of certain products promoted for arthritis and pain management that have been found to contain hidden ingredients and may pose a significant […]
[4-17-2024] The Food and Drug Administration is advising consumers not to purchase or use Ossos-Sans, a product promoted and sold for pain on various websites, including https://alnaturaleshop.com, […]
Medication Safety Two-Year Medication Error Pharmacovigilance and Risk Management Fellowship provided by Butler University Fellowship dates: TBD, typical timeline shown below. Four months will be spent […]
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