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FTC Warns Makers of CBD-Infused Products

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

Medical Devices

Metrix Recalls IV Flexible Bags

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

Human Drugs

Abuse, Dependence Labeling Comments

Three drug companies respond to an FDA draft guidance on package insert labeling in the drug abuse and dependence section.

Human Drugs

Improve and Pass H.R. 3: Public Citizen

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

Human Drugs

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

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

Human Drugs

Doctor Sues FDA Over Internet Abortion Drugs

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

Federal Register

Info Collection for Symbols in Device Labeling

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

Human Drugs

CGMP Issues in Enprani Inspection

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

Human Drugs

CluePoints, FDA Clinical Trial Site Selection Model

CluePoints and FDA extend their cooperative research and development agreement that is exploring a data-driven approach to selecting clinical trial si...

Federal Register

25 No-Longer-Marketed NDAs Withdrawn

Federal Register notice: FDA withdraws approval of 25 NDAs from multiple applicants after they notified the agency that the drug products were no long...