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Three drug companies respond to an FDA draft guidance on package insert labeling in the drug abuse and dependence section.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

Doctor Sues FDA Over Internet Abortion Drugs

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A Dutch physician sues FDA in Idaho federal court after the agency seized several international packages containing abortion drugs...

Info Collection for Symbols in Device Labeling

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Federal Register notice: FDA submits to OMB an information collection extension for Medical Devices; Use of Symbols in Labeling G...

CGMP Issues in Enprani Inspection

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FDA warns South Koreas Enprani Co. about CGMP and other violations in its manufacturing of finished pharmaceuticals.