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General Regulatory Drug Approval

March 29, 2022

FDA’s Expedited Programs Explained

In order to incentivize the development of therapies (drugs biologics) to fill unmet medical needs for treatment of serious conditions, the FDA has developed various programs to expedite drug...

Agency Alerts Ophthalmic

March 22, 2022

FDA Issues Guidance on Certain Ophthalmic Products: Policy for Compliance with 21 CFR Part 4

The U.S. Food and Drug Administration today issued the guidance for industry, Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4. This guidance provides information to...

General Regulatory Drug Approval

October 5, 2021

Four Benefits of Requesting an FDA Pre-IND Meeting

Although not required, a Pre-IND Meeting is a critical milestone, one that is highly recommended by the FDA. The goal of the meeting is to receive general agreement from FDA that your drug...

Generic Drugs Agency Alerts

August 22, 2019

Only 12% of Generic Drugs Reviewed Were Approved in the 1st Review Cycle, says GAO Report

On August 7th, the U.S. Government Accountability Office (GAO) published its report on generic drug applications.  In the report, GAO comments on the number of products approved on the first review...

Agency Alerts General Regulatory

March 15, 2019

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On Thursday, March 7th, FDA published a revised draft guidance, updating its nonproprietary naming convention for biological products licensed under section 351 of the Public Health Service Act (PHS...

Medical Device Agency Alerts

February 28, 2019

Draft Guidance: Requesting Nonbinding Feedback After an FDA Inspection of Your Medical Device Establishment

On Tuesday, February 19th, FDA published a draft guidance for medical device makers which identifies a process for companies to request nonbinding feedback on certain FDA Form 483 deficiencies noted...

Agency Alerts General Regulatory

February 22, 2019

FDA Warns Health Care Providers About the Development of Cancer After Breast Implants

On Wednesday, February 6th, FDA issued a letter to health care providers to increase the awareness of an association between all breast implants and Breast Implant Associated-Anaplastic Large Cell...

Agency Alerts General Regulatory

February 18, 2019

FDA Approves First Therapy for Rare Blood-Clotting Disorder

On Wednesday, February 6th, FDA approved the Cablivi®(caplacizumab-yhdp) injection, the first product approved in combination with plasma exchange and immunosuppression specifically for adults with...

Medical Device Agency Alerts

February 12, 2019

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...

Statistical Intervals Confidence Interval Process Validation Life Science Consulting featured-image

Aug 15, 2013 12:00:00 AM

Understanding Statistical Intervals: Part 2 - Prediction Intervals

Part 1 of this series discussed confidence intervals. Confidence intervals are the best known of the statistical intervals but they only bound regions associated with population parameters; i.e., the...

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General Regulatory Drug Approval Regulatory Sciences featured-image

Mar 29, 2022 12:00:00 AM

FDA’s Expedited Programs Explained

In order to incentivize the development of therapies (drugs biologics) to fill unmet medical needs for treatment of serious conditions, the FDA has developed various programs to expedite drug...

Read More
Biostatistics Clinical Research Solutions featured-image

Dec 22, 2020 12:00:00 AM

How Important is Biostatistics?

The link between statistical methods and healthcare is not a new one, but the volume of available data to inform healthcare decisions and the use of data science in the medical industry has exploded...

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ICH MW QC CSR Clinical Research Solutions featured-image

Dec 8, 2020 12:00:00 AM

A Guide to the Clinical Study Report

What is a Clinical Study Report? A Clinical Study Report (CSR) is a document that describes the methods and results of a clinical study or trial, along with a short discussion of key findings related...

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General Regulatory FDA Meetings Regulatory Sciences featured-image

Feb 28, 2017 12:00:00 AM

Formal Meetings Between the FDA & Sponsors or Applicants of PDUFA Products

On March 10, 2015, the FDA published a draft guidance, providing a number of recommendations regarding the conduct of formal meetings between the FDA and Sponsors. These meetings are intended to...

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Regulatory Sciences featured-image

Oct 12, 2022 12:00:00 AM

Prescription Drug User Fee Act (PDUFA) VII and Type D Meetings: A New Mechanism for Interacting with FDA

For those who have been awaiting Congressional reauthorization of PDUFA, the wait is over. On September 30, 2022, the President signed into law the FDA User Fee Reauthorization Act of 2022. We...

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