EMA Takes Steps to Minimize Animal Testing During Product Development

On Wednesday, September 29th, EMA announced the implementation of new measures indented to replace, reduce, and refine animal use in the development, manufacturing, and testing of human and...

FDA Monographs and Current Regulations for Sunscreen Products

Over-the-counter (OTC) drugs are defined by the FDA as drugs that are safe and effective for use by the general public without seeking treatment by a health professional. Currently, there are more...

Clinical Research Solutions

How to Survive a Multi-Year Consent Decree

Operating a business under a Consent Decree is extremely difficult; there is no area of the business that goes unaffected. In addition to fines that could reach $500 million, a three to five-year...

FDA Announces Update to Nonproprietary Naming Convention for Biosimilar Products

On Thursday, March 7th, FDA published a revised draft guidance, updating its nonproprietary naming convention for biological products licensed under section 351 of the Public Health Service Act (PHS...

FDA Approves Nasal Spray to Treat Depression in Adults

Earlier this month, FDA announced the approval of Spravato (esketamine) nasal spray. The product is to be used in conjunction with an oral antidepressant and is indicated for the treatment of...

FDA Issues Draft Guidance to Advance Development of Combination Products

On Tuesday, February 5th, FDA published a draft guidance explaining the principles for premarket review of combination products, including how to determine which type of premarket submission is...

Regulatory Sciences

FDA Draft Guidance on Tentatively Approved ANDA Submissions

On Wednesday, January 16th, the FDA published its first draft guidance since the partial government shutdown took effect on December 22, 2018. The draft guidance, entitled "ANDA Submissions –...

Human Subject Protection Regulations: Differences Between HHS’ & FDA’s Clinical Trial Rules

On Friday, October 12th, FDA issued a guidance document entitled “Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.” The document aims to help...

FDA Prescription Drug User Fee Rates: Fiscal Year 2019

On Wednesday, August 1st, FDA released a notice with updated prescription drug user fee rates for fiscal year 2019. Prescription Drug Application Fees According to the Food, Drug, & Cosmetic (FD&C)...

FDA Steps up its Game on Generic Drugs: The Story Behind the Recent Focus on Generic Products

Throughout 2017, the FDA focused its attention on the regulation of generic drug products. In 2015, the Agency issued only two generic-related guidance documents. In 2016, there were seven. In 2017,...

Regulatory Sciences

Finding a Roadmap to Approval - Hint: You Can't Pick One Up at the FDA

Earning FDA approval for your drug program is a journey. A misstep at any point of that journey could jeopardize your chance at getting your drug approved. That’s why it’s so important to have a...

7 Things to Consider Before Selecting a CRO

Selecting the right contract research organization (CRO) is one of the most important decisions you, as a sponsor, must make. That’s because CROs can improve efficiency and increase productivity,...

Clinical Quality Systems & the Outsourced Model

The landscape of clinical trials is evolving. The changes that are happening are due to the increased number of FDA-regulated trials, as well as a rise in the complexity of clinical protocols. As...

Senators work to Reform FDA’s Medical Device Inspection Process with Bipartisan Bill

On Wednesday, February 15th, Senators Michael Bennet (D – CO) and Johnny Isakson (R – GA) introduced a bill to improve FDA’s medical device inspection process. If passed, the bill would amend the...

Clinical Research Solutions

#2: Labeling for Human Prescription Drug and Biological Products – Implementing the PLR Content and Format Requirements

In 2013, the FDA released a guidance entitled "Labeling for Human Prescription Drug and Biological Products – Implementing the PLR Content and Format Requirements." This guidance was finalized after...

#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...