Clinical Research Solutions
FDA Generic Drug User Fee Rates: Fiscal Year 2019
On Friday, July 27th, FDA released a notice with updated generic drug user fee rates for fiscal year 2019. Under GDUFA II, user fees should total $493,600,000 each year, adjusted for inflation. The...
Clinical Research Solutions
FDA Releases Draft Guidance on Nonprescription Drugs
On Tuesday, July 17th, FDA released a new draft guidance entitled “Innovative Approaches for Nonprescription Drug Products.” The guidance discusses two different approaches for making nonprescription...
Clinical Research Solutions
FDA Approves 1st Drug to Treat Smallpox
On Friday, July 13th, FDA approved TPOXX (tecovirimat) for the treatment of smallpox. According to the World Health Organization (WHO), smallpox was eradicated in 1980; however, since eradication...
Clinical Research Solutions
FDA Announces Voluntary Recall of Drugs Containing Valsartan
On Friday, July 13th, FDA announced the voluntary recall of several drugs containing the active ingredient valsartan. Valsartan is often used to treat serious medical conditions such as high blood...
Clinical Research Solutions
FDA Releases Six Draft Guidances Related to Gene Therapy
On Wednesday, July 11th, FDA released six draft guidances to aid in the development of new gene therapies. Of the six guidances, three were disease specific and three were related to manufacturing....
Clinical Research Solutions
FDA Issues Untitled Letter to Pfizer for False or Misleading Video
On June 19th, FDA’s Office of Prescription Drug Promotion (OPDP) sent an untitled letter to Pfizer Inc. regarding an online direct-to-consumer (DTC) video featuring Estring® (estradiol vaginal ring)....
Clinical Research Solutions
FDA Approves First Marijuana-Derived Drug for the Treatment of Epilepsy
On Monday, June 25th, FDA approved GW Pharmaceuticals’ Epidiolex (cannabidiol) for the treatment of two rare and severe forms of epilepsy. Epidiolex is the first FDA-approved drug that contains a...
Clinical Research Solutions
FDA Updates Guidance on User Fee Waivers, Reductions, & Refunds
On Wednesday, June 20th, FDA announced the availability of a draft guidance entitled "Prescription Drug User Fee Waivers, Reductions, and Refunds for Drug and Biological Products." The guidance is an...
Clinical Research Solutions
FDA Announces Two Initiatives to Support Generic Drug Competition
On Monday, June 18th, FDA introduced two initiatives intended to increase access to generic drugs and promote generic competition. The Agency requested $37.6 million in fiscal year 2019 to fund these...
Clinical Research Solutions
First Clinical Study Report Data Published for FDA Pilot Project
On Monday, March 19th, the FDA officially began a new Clinical Data Summary Pilot Program. This program is intended to “assess the feasibility of using a different format to provide required...