general regulatory

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FDA Draft Guidance on Tentatively Approved ANDA Submissions

On Wednesday, January 16th, the FDA published its first draft guidance since the partial government shutdown took effect on December 22, 2018. The draft guidance, entitled "ANDA Submissions –...

Block numbers of 2018 turning into 2019.

Clinical Research Solutions

Year in Review: Taking a Look at Pharma's Top News Stories & Events from 2018

From FDA's approval of the first cannabis-based product in the U.S., to the classification of two Apple Watch apps and changes in the Agency's submission requirements related to Sponsor meetings,...

Business worker with virtual attendees in conference room

Regulatory Sciences

CBER Provides Sponsors with Policies and Procedures Regarding INTERACT Meetings

On Monday, October 1, FDA’s Center for Biologics Evaluation and Research (CBER) issued a document outlining the policies and procedures for scheduling and conducting INitial Targeted Engagement for...

Regulatory Sciences

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 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,...

Clinical Research Solutions

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 Research Solutions

FDA Meetings: How to Prepare for FDA Type B Meetings

The Food and Drug Administration has laid out a drug development continuum that includes three milestones, or Type B meetings. Earliest is the Pre-IND Meeting, the second is the End of Phase 2 (EOP2)...

Clinical Research Solutions

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...

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...

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