Clinical Research Solutions
Good Review Management Principles & Practices, Part Two: Operational Principles
Details on the fundamental values outlined on FDA’s GRMP draft guidance are available in our preceding article, entitled “Good Review Management Principles & Practices, Part One: Fundamental Values"...
Clinical Research Solutions
Good Review Management Principles & Practices, Part One: Fundamental Values
On Tuesday, September 25th, the FDA published a draft guidance containing recommendations on good review management principles and practices (GRMPs) for new drug applications (NDAs), Biologics...
Clinical Research Solutions
Generic Failure: Why so Few ANDAs Are Accepted by FDA on the First Pass
Generic drugs are immensely important to the U.S. healthcare system. These drugs account for 89% of the prescriptions dispensed in the United States. And, over the last decade, generic drugs have...
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FDA Releases Draft Guidance on Nonprescription Drugs
On Tuesday, July 17th, FDA released a new draft guidance entitled “Innovative Approaches for Nonprescription Drug Products.”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 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 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On Wednesday, June 20th, FDA announced the availability of a draft guidance entitled "Prescription Drug User Fee Waivers, Reductions, and Refunds for Drug and Biological Products."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
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...
Clinical Research Solutions
FDA Issues Final Rule to Delay Implementing Parts of ‘Intended Use’ Regulation
On Friday, March 16th, the FDA published a notice in the Federal Register, stating that the effective date for the amendments related to intended use would be delayed indefinitely. In the notice, the...