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Home » Topics » Pharmaceuticals » Regulatory Affairs

Regulatory Affairs
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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
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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

Celltrion Healthcare Gets EU’s OK for Remsima SC to Treat Rheumatoid Arthritis

December 9, 2019
CT-P13 was approved by the FDA in 2016 under the trade name Inflectra. Read More

Bipartisan Lawmakers Begin Work on Cures 2.0

December 9, 2019
Upton and DeGette are asking for public comment by Dec. 16 on what Cures 2.0 should include. Read More

Novartis Boosts Heart Treatment Portfolio With $9.7 Billion Deal

December 9, 2019
The Medicines Company plans to file for FDA approval by the end of the year. Read More

Patient Charity Settles DOJ Allegations it Helped MS Drugmakers Pay Kickbacks

December 9, 2019
The charity entered into a three-year deal that requires it to operate independently. Read More
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Florida Stem-Cell Supplier Draws Untitled Letter for False Claims

December 9, 2019
The website included patient testimonials for the product as treatments for asthma, knee and spine pain, and arthritis, the agency noted. Read More
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