Insights

23
Mar
2021

Medical Device Submission: What Go to Market Pathways Can You Take?

Any medical device that will be marketed and sold in the United States must receive the necessary approval from the FDA through their regulatory process. There are multiple pathways to navigate this regulatory process.
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16
Mar
2021

FDA Authority & Cosmetics: What You Need to Know

Cosmetics and other beauty products are obviously not food or drugs so it might be surprising to some that the FDA has authority over these products. Since these health and beauty products will be put on people’s faces and bodies, it was deemed important to have an authority verifying the safety of the ingredients.
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09
Mar
2021

Preparing for CMC Regulatory Compliance: The Basics & More

Are you familiar with the latest Chemistry, Manufacturing and Controls (CMC) regulatory compliance requirements?
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23
Feb
2021

The Main Phases of Clinical Research: Going From Preclinical to Phase IV

Over the last few months, people all over the world watched as various COVID-19 vaccinations completed the different phases of clinical research, nearing ever-closer to approval.

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16
Feb
2021

The Different Types of FDA Inspections: What You Need to Know

For those manufacturing drugs, medical devices, or anything else regulated by the United States Food and Drug Administration (FDA), an inspection conducted by the FDA is expected. Inspections are to verify that the manufacturers are compliant with any and all regulations.
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10
Feb
2021

The Center for Professional Innovation & Education Launches New Laboratory Equipment Validation and Qualification Course

The Center for Professional Innovation and Education (CfPIE) is excited to announce our latest course, Laboratory Equipment Validation and Qualification. This virtual course will run March 8 & 9th, and is designed for individuals who perform, supervise, manage, audit, or oversee the validation of text methods in any lab utilizing cGMP, GLP, and similar manufacturing processes.
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09
Feb
2021

The Pros and Cons of Using a CRO: The Basics and More

Many companies that are in the process of developing new medicines might outsource work to a Contract Research Organization (CRO).

This decision was possibly made to save money, to guarantee work completed within time and budget constraints, or to benefit from industry expertise.
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02
Feb
2021

European Medicines Agency's (EMA) Process for Vaccine Approval

As each new COVID-19 vaccination is announced, every region waits for approval for distribution to begin. The UK was the first country to approve the first vaccine, with the FDA in the United States of America following soon after.
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19
Jan
2021

Lyophilization and Its Application for the Pfizer Vaccine

As the news is inundated with stories about COVID-19, the world celebrated when the first vaccine from Pfizer was approved.
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05
Jan
2021

Everything We Know About the New Variant of COVID-19

A new variant of the coronavirus, first detected in the United Kingdom, has prompted dozens of travel bans and strict, tier four mixing rules for millions of people in England, Scotland, and Wales.
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15
Dec
2020

Become a Certified Medical Writing Professional (CMWP)

Medical communication plays a fundamental role in not just research but also regulatory processes, pharmaceutical marketing, health education, and the shaping of public health policies. Medical writers have the challenging task of distilling highly technical information to a variety of stakeholders.
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08
Dec
2020

Understanding Pharmaceutical Guidelines: GLP vs. GMP

The difference between good manufacturing practices (GMPs) and good laboratory practices (GLPs) aren’t always clear. In practice, confusing one for the other can lead to extra work at best and non-compliance at worst.
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24
Nov
2020

FDA Authorizes Most Accurate Antibody Test Yet

On November 25, the US Food and Drug Administration (FDA) granted an emergency use authorization (EUA) for a quantitative antibody test that can detect and measure levels of COVID-specific neutralizing antibodies.
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17
Nov
2020

FDA Approves First At-Home Self-Testing Kit for COVID-19

On November 17, the US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the first at-home self-testing kit for COVID-19.
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10
Nov
2020

New Vaccines Are More Than 90% Effective

On November 9, Pfizer and BioNTech announced that their COVID-19 vaccine candidate showed promising results in Phase 3 clinical trials. Preliminary findings suggest that the vaccine can prevent COVID-19 in more than 90% of people.
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03
Nov
2020

How Effective Does a COVID-19 Vaccine Need to Be?

The “effectiveness” of a vaccine can refer to a constellation of factors: What percentage of vaccinated people develop antibodies? How well do antibodies protect against the disease? How long does this protection last?
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27
Oct
2020

FDA Approves the First Treatment for COVID-19

On October 22, the Food and Drug Administration (FDA) approved remdesivir to treat COVID-19, making it the first and only COVID-19 treatment to have received full federal approval.
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20
Oct
2020

Your Guide to Preparing a Validation Protocol

Validation involves much more than end-product testing. Confirming a product’s safety solely through end-product testing is dangerous—how can you be sure that every pill will be the same?
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13
Oct
2020

FDA Regulatory Relaxations Due to COVID-19

Over recent months, the U.S. Food and Drug Administration (FDA) has relaxed regulations in several areas to keep up with the COVID-19 pandemic. Regulatory relaxations have been made to address interruptions in the supply chain, expedite clinical trials and product reviews, and increase the accessibility of both diagnostic tests and treatments.
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