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Latest posts

Last updated about 3 hours ago

FDA approves alectinib as adjuvant treatment for ALK-positive non-small cell lung cancer

about 8 hours ago

On April 18, 2024, the Food and Drug Administration approved alectinib (Alecensa...

Tainted Weight Loss Products

about 8 hours ago

FDA is notifying consumers of certain products promoted for weight loss that...

Biosimilars Action Plan

about 11 hours ago

FDA is committed to encouraging innovation and competition for biologics and facilitating...

Updated Information | Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs)

about 11 hours ago

Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs); Updated Information

Guidance, Compliance, & Regulatory Information

about 12 hours ago

Looking for FDA Guidance, Compliance, & Regulatory Information? Web page provides quick...

Pharmaceutical Inspections and Compliance

about 12 hours ago

One way FDA works to ensure drug manufacturers comply with Current Good...

Patient Medication Information: A 2023 Proposed Rule to Help Patients Understand Their Prescription Medication Information

about 15 hours ago

FDA proposed a new type of Medication Guide known as Patient Medication...

Tainted Arthritis | Pain Products

1 day ago

FDA is notifying consumers of certain products promoted for arthritis and pain...

Ossos-Sans contains hidden drug ingredients

1 day ago

The Food and Drug Administration is advising consumers not to purchase or...

Notable Approvals | Drugs

1 day ago

News about human drug-related approvals

Regulatory Pharmaceutical Fellowship Program

1 day ago

Information about the two-year post-graduate Regulatory Pharmaceutical Fellowship program. This program is...

Fiscal Year 2024 Generic Drug Science and Research Initiatives Public Workshop - 05/20/2024

1 day ago

The purpose of the public workshop is to provide an overview of...