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Hangzhou Badi CGMP Violations

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FDA warns Chinas Hangzhou Badi Daily Use Chemical Company about CGMP and other violations in its manufacturing of finished drugs.

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Enprani Co., and Hangzhou Badi Daily Use Chemical.

Public Citizen Sues FDA Seeking Cesium Chloride Ban

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Public Citizen 9/10 sues FDA in Washington, DC federal court over the agencys inaction to respond to the groups 7/2018 citizen pet...

FDA Develops Hepatitis A Immune Response Biomarker

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FDA says its scientists have developed a way to determine whether dendritic cells are primed to trigger production of antibodies a...

Ipca Laboratories FDA-483

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FDA releases an FDA-483 issued to Indias Ipca Laboratories with three inspection observations.

FTC Warns Makers of CBD-Infused Products

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The Federal Trade Commission warns three companies that they need credible and reliable scientific evidence to make health claims ...

Metrix Recalls IV Flexible Bags

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The Metrix Co. (Dubuque, IA) recalls several lots of its empty IV flexible containers due to the potential for leakages from the I...

Abuse, Dependence Labeling Comments

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Three drug companies respond to an FDA draft guidance on package insert labeling in the drug abuse and dependence section.

Improve and Pass H.R. 3: Public Citizen

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Public Citizen calls on the House to improve H.R. 3 to lower drug prices and then pass the legislation.

Some Post-Approval Studies Need a Long Time: Opinion Post

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Forbes contributor John LaMattina defends the long time needed to complete some drug post-approval studies.