Regulatory Affairs

FDA to Clarify Regulatory Status of Cannabidiol, Abernethy Says

December 10, 2019

Unapproved CBD products have not been evaluated for proper dosage, potential interactions with other FDA-approved drugs, or side effects, and the manufacturing process of unapproved CBD products has not been subjected to FDA review, she said. Read More

OPDP Warns Michigan Drugmaker for Product Claims, Missing Warnings

December 10, 2019

The company did not note that the FDA-approved indication did not include patients receiving dialysis through the abdomen. Read More

Federal Prosecutors Criminally Probe Drugmakers Compliance With Controlled Substances Act

December 10, 2019

Prosecutors are going after pharma companies and their compliance with the CSA, which is usually used to prosecute drug dealers. Read More

Restructuring of CDER’s Office of New Drugs Passes Half-Way Mark

December 10, 2019

The third phase will put in place the Office of Non-Prescription Drugs and the Office of Specialty Medicine. Read More

Federal Judge Says FDA Can't Regulate Barium Product as a Drug

December 9, 2019

A federal judge has ruled that the FDA can no longer regulate barium sulfate as a drug. Read More

White House Supports Updated Grassley-Wyden Drug Pricing Package

December 9, 2019

Senate Finance Committee Chairman Chuck Grassley (R-Iowa) and ranking member Ron Wyden (D-Ore.) have updated their bipartisan drug pricing legislation with provisions to reduce out-of-pocket expenses — and President Trump has said he would sign it into law. Read More

House Republicans Unveil Alternative to Pelosi’s H.R. 3

December 9, 2019

Four high-ranking House Republicans introduced drug pricing legislation Monday designed to replace House Speaker Nancy Pelosi’s H.R. 3, a bill they dismissed as one-sided and doomed to fail. Read More