Clinical Research Solutions
FDA Approves First Drug for a Form of Batten Disease
On Thursday, April 27th, the FDA announced the approval of Brineura™ (cerliponase alfa). Brineura, manufactured by BioMarin International Ltd., is an infusion indicated for the treatment of...
Clinical Research Solutions
FDA Approves 5th Biosimilar Product
On Friday, April 21st, Reneflexis® (SB2, infliximab – abda) was approved by the FDA. Reneflexis is manufactured by Samsung Bioeipis, and is a biosimilar product to Janssen’s Remicade® (infliximab)....
Clinical Research Solutions
FDA Approves New Treatment for Moderate-to-Severe Eczema
On Tuesday, March 28th, the FDA announced the approval of Dupixent (dupilumab), an injection for the treatment of adults with moderate-to-severe atopic dermatitis. What is Atopic Dermatitis? Atopic...
Clinical Research Solutions
#3: Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route
In October 2015, the FDA published a guidance document which outlines its recommendations regarding “the nonclinical evaluation of previously approved drug substances when a new formulation or a new...
Clinical Research Solutions
FDA Approves Erelzi™, the Third US Biosimilar Product
On Wednesday, August 30th, the FDA announced the approval of Sandoz’s Erelzi™ (etanercept-szzs). Erelzi is biosimilar to Amgen’s Enbrel® (etanercept) and is indicated for the treatment of multiple...
Clinical Research Solutions
FDA Prescription Drug User Fee Rates: Fiscal Year 2017
The Prescription Drug User Fee Amendments of 2012 (PDUFA V) allows FDA to collect user fees for the review of applications concerning human drug and biological products, the establishments where...
Clinical Research Solutions
FDA Revises Review Timeline Due to Increasing Number of Orphan Drug Applications
FDA Revises Review Timeline Due to Increasing Number of Orphan Drug Applications: In 1983 Congress passed the Orphan Drug Act, which created FDA’s Orphan Drug Designation (ODD) program. The goal of...
Clinical Research Solutions
FDA Outlines Policies for Compounding Drug Products That Are Essentially Copies of Commercially Available Drugs Under Section 503A of the FD&C Act
On Thursday, July 7th, the FDA issued two draft guidance documents regarding the compounding of drugs that are essentially copies of commercially available or approved drugs. In these documents,...
Clinical Research Solutions
Federal Circuit Court Requires Biosimilar Makers Participate in “Patent Dance” & Give 180-Day Notice
On Tuesday, July 5th the Federal Circuit Court announced the final decision in the case of Amgen v. Apotex, ruling that manufacturers of biosimilar products must notify their brand-name competitors...
Clinical Research Solutions
FDA Guidelines for Post-Approval CMC Changes, Part Two: Contents of Comparability Protocol Submissions
Additional information on FDA's draft guidance is available in our preceding FDA News article, entitled "FDA Guidelines for Post-Approval CMC Changes, Part One: Overview of the Updated Draft...